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Apósitos hidrocoloides para la cicatrización de las úlceras del pie diabético

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References

References to studies included in this review

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Clever 1995 {published data only}

Clever HU, Dreyer M. Comparing two wound dressings for the treatment of neuropathic diabetic foot ulcers. Proceedings of the 5th European Conference on Advances in Wound Management; 1995, 21‐24 November; Harrogate, UK. 1995:201‐3.

Jeffcoate 2009 {published data only}

Jeffcoate WJ, Price PE, Phillips CJ, Game FL, Mudge E, Davies S, et al. Randomised controlled trial of the use of three dressing preparations in the management of chronic ulceration of the foot in diabetes. Health Technology Assessment 2009;13(54):1‐110.

Jude 2007 {published data only}

Jude EB, Apelqvist, Spraul M, Martini J. Prospective randomized controlled study of Hydrofiber dressing containing ionic silver or calcium alginate dressings in non‐ischaemic diabetic foot ulcers. Diabetic Medicine 2007;24(3):280‐8.

Kuo 2012 {published data only}

Kuo Y‐S, Chien H‐F, Lu W. Plectranthus amboinicus and Centella asiatica Creamforthe Treatment of Diabetic Foot Ulcers. Evidence‐Based Complementary and Alternative Medicine 2012;418679:doi: 10.1155/2012/418679.

Piaggesi 2001 {published data only}

Piaggesi A, Baccetti F, Rizzo L, Romanelli, Navalesi R, Benzi L. Sodium carboxyl‐methyl‐cellulose dressings in the management of deep ulcerations of diabetic foot. Diabetic Medicine 2001;18(4):320‐4.

References to studies excluded from this review

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Agas 2006 {published data only}

Agas CM, Bui TD, Driver VR, Gordon IL. Effect of window casts on healing rates of diabetic foot ulcers. Journal of Wound Care 2006;15(2):80‐3.

Ahroni 1993 {published data only}

Ahroni JH, Boyko EJ, Pecoraro RE. Diabetic foot ulcer healing: extrinsic vs intrinsic factors. Wounds 1993;5(5):245‐55.

Altman 1993 {published data only}

Altman MI, Mulder GD. Multi‐centre evaluation of Nu‐Gel wound dressing in full‐thickness chronic wounds of the lower extremities. 3rd European Conference on Advances in Wound Management; 1993, 19‐22 October; Harrogate, UK. 1993:164‐5.

Alvarez 2003 {published data only}

Alvarez OM, Roger RS, Booker JG, Patel M. Effect of non contact normothermic wound therapy on the healing of neuropathic (diabetic) foot ulcers: an interim analysis of 20 patients. Journal of Foot and Ankle Surgery 2003;42(1):30‐5.

Apelqvist 1990 {published data only}

Apelqvist J, Larsson J, Stenstrom A. Topical treatment of necrotic foot ulcers in diabetic patients: a comparative trial of DuoDerm and MeZinc. British Journal of Dermatology 1990;123:787‐92.

Apelqvist 1996 {published data only}

Apelqvist J, Ragnarson‐Tennvall G. Cavity foot ulcers in diabetic patients: a comparative study of cadexomer iodine ointment and standard treatment. An economic analysis alongside a clinical trial. Acta Dermato‐Venereologica 1996;76(3):321‐5.

Apelqvist 2004 {published data only}

Apelqvist J, Piaggesi A. Enamel matrix protein in diabetic foot ulcers, a controlled multicentre study. 2nd World Union of Wound Healing Societies Meeting; 2004 ,8‐13 July; Paris. 2004:8‐13.

Armstrong 2004 {published data only}

Armstrong DG, Lavery LA, Frykberg RG, Andros G, Attinger CE, Boulton AJM. VAC therapy appears to heal complex DFU. 2nd World Union of Wound Healing Societies Meeting; 2004 ,8‐13 July; Paris. 2004:22.

Baker 1993 {unpublished data only}

Baker NR, Creevy J. A randomised comparative pilot study to evaluate Allevyn hydrocellular dressings and Sorbsan calcium‐alginate dressings in the treatment of diabetic foot ulcers. Unpublished1993.

Belcaro 2010 {published data only}

Belcaro G, Cesarone MR, Errichi BM, Ricci A, Dugall M, Pellegrini L, et al. Venous and diabetic ulcerations: management with topical multivalent silver oxide ointment. Panminerva Medica 2010;52(2 (Suppl 1)):37‐42.

Blackman 1994 {published data only}

Blackman JD, Senseng D, Quinn L, Mazzone T. Clinical evaluation of a semipermeable polymeric membrane dressing for the treatment of chronic diabetic foot ulcers. Diabetic Care 1994;17(4):322‐5.

Bogaert 2004 {published data only}

Bogaert T, Meert S, Derre B, Goethals E. Topical autologous platelet gel enhances healing of chronic diabetic ulcer: Preliminary report. 2nd World Union of Wound Healing Societies Meeting; 2004 ,8‐13 July; Paris. 2004:114.

Bradshaw 1989 {published data only}

Bradshaw T, Gem J, Boulton A. The use of Kaltostat in the treatment of ulceration in the diabetic foot. Chiropodist 1989;44(9):204‐7.

Caravaggi 2003 {published data only}

Caravaggi C, De Giglio R, Pritelli C, Sommaria M, Dalla Noce S, Faglia E, et al. HYAFF 11‐based autologous dermal and epidermal grafts in the treatment of noninfected diabetic plantar and dorsal foot ulcers: a prospective, multicenter, controlled, randomized clinical trial. Diabetes Care 2006;10:2853‐9.

Chang 2000 {published data only}

Chang DW, Sanchez LA, Veith FJ, Wain RA, Okhi T, Suggs WD. Can a tissue‐engineered skin graft improve healing of lower extremity foot wounds after revascularization?. Annals of Vascular Surgery 2000;14(1):44‐9.

Chauhan 2003 {published data only}

Chauhan VS, Rasheed MA, Pandley SS, Shukla VK. Nonhealing wounds ‐ a therapeutic dilemma. International Journal of Lower Extremity Wounds 2003;2(1):40‐5.

Chirwa 2010 {published and unpublished data}

Chirwa Z, Bhengu T, Litiane K. The cost effectiveness of using calcium alginate silver matrix in the treatment of wounds. European Wound Management Association Journal 2010;10(2):257, Abstract P299.

Cuevas 2007 {published data only}

Cuevas FR, Velázquez Méndez AA, Andrade IC. Zinc hyaluronate effects on ulcers in diabetic patients [Efecto delhialuronato de zinc sobre las úlceras en pacientes con diabetes]. Gerokomos 2007;18(2):91‐105.

D'Hemecourt 1998 {published data only}

D'Hemecourt PA, Smiell JM, Karim MR. Sodium carboxymethyl cellulose aqueous‐based gel vs becaplermin gel in patients with nonhealing lower extremity diabetic ulcers. Wounds 1998;10(3):69‐75.

Dash 2009 {published data only}

Dash NR, Dash SN, Routray P, Mohapatra S, Mohapatra PC. Targeting nonhealing ulcers of lower extremity in human through autologous bone marrow‐derived mesenchymal stem cells. Rejuvenation Research 2009;12(5):359‐66.

Diehm 2005 {published data only}

Diehm C, Lawall H. Evaluation of Tielle hydro polymer dressings in the management of chronic exuding wounds in primary care. International Wound Journal 2005;2(1):26‐35.

Donaghue 1998 {published data only}

Donaghue VM, Chrzan JS, Rosenblum BI, Giurini JM, Habershaw GM, Veves A. Evaluation of a collagen‐alginate wound dressing in the management of diabetic foot ulcers. Advances in Wound Care 1998;11(3):114‐9.

Driver 2006 {published data only}

Driver VR, Hanft J, Fylling CP, Beriou JM, and Autologel Diabetic Foot Ulcer Study Group. A prospective randomized controlled trial of autologous platelet‐rich plasma gel for the treatment of diabetic foot ulcers. Ostomy/Wound Management 2006;52(6):68‐70, 72, 74.

Edmonds 2009 {published data only}

Edmonds M. Apligraf in the treatment of neuropathic diabetic foot ulcers. International Journal of Lower Extremity Wounds 2009;8(1):11‐8.

Eginton 2003 {published data only}

Eginton MT, Brown KR, Seabrook GR, Towne JB, Cambria RA. A prospective randomized evaluation of negative‐pressure wound dressings for diabetic foot wounds. Annals of Vascular Surgery 2003;17(6):645‐9.

Etoz 2003 {published data only}

Etoz A, Ozgenel Y, Ozcan M. The use of negative pressure wound therapy on diabetic foot ulcers: a preliminary controlled trial. Wounds: A Compendium of Clinical Research and Practice 2004;16(8):264‐9.

Farac 1999 {published data only}

Farac KP, Grief R, Sessler DI. Radiant heat bandage speeds healing of diabetic‐neuropathic foot ulcers. 31st Annual Wound, Ostomy and Continence Conference; 1999 June; Minneapolis, MN. 1999:488.

Foo 2004 {published data only}

Foo LSS, Chua BSY, Chia GT, Tan SB, Howe TS. Vacuum assisted closure vs moist gauze dressing in post‐operative diabetic foot wounds: early results from a randomised controlled trial. 2nd World Union of Wound Healing Societies Meeting; 2004 ,8‐13 July; Paris. 2004:8‐9.

Foster 1994 {published data only}

Foster AVM. Comparing dressings for diabetic foot ulcers ‐ letter. Journal of Wound Care 1995;4(1):10.
Foster AVM, Greenhill MT, Edmonds ME. A randomised comparative study to compare Allevyn hydrocellular dressings and Kaltostat calcium‐sodium alginate dressings in the treatment of diabetic foot ulcers. 5th Annual Symposium on Advanced Wound Care; 1992, 23‐25 April; New Orleans, Lousiana. 1992:146.
Foster AVM, Greenhill MT, Edmonds ME. A randomised comparative study to compatre Allevyn hydrocellular dressings and Kaltostat calcium‐sodium alginate dressings in the treatment of diabetic foot ulcers. 2nd European Conference on Advances in Wound Management; 1992, 20‐23 October; Harrogate, UK. 1993:77.
Foster AVM, Greenhill MT, Edmonds ME. Comparing two dressings in the treatment of diabetic foot ulcers. Journal of Wound Care 1994;3(5):224‐8.

Foster 1999 {published data only}

Foster A, Bates M, Doxford M, Edmonds ME. Treatment of indolent neuropathic ulceration of the diabetic foot with Hyaff. The Diabetic Foot 1999;2(2):72.

Gao 2007 {published data only}

Gao L, Xu GX, Zhou HB. Efficacy evaluation of diabetic foot ulceration treated with iodophors dressings therapy. Journal of Clinical Nursing 2007;6(4):21‐2.

Gentzkow 1996 {published data only}

Gentzkow GD, Iwasaki SD, Hershon KS, Mengel M, Prendergast JJ, Ricotta JJ, et al. Use of Dermagraft, a cultured human dermis, to treat diabetic foot ulcers. Diabetes Care 1996;19(4):350‐4.

Gottrup 2011 {published data only}

Gottrup F, Gibson M, Karlsmark T, Bishoff‐Mikkelsen M, Nisbet L, Cullen B. Collagen/ORC/silver treatment of diabetic foot ulcers; a randomised controlled trial. Wound Repair and Regeneration  2011;19(2):A24.
Gottrup F, Karlsmark T, Cullen B, Gibson M, Nisbet L. Comparative clinical study to determine the effects of collagen/orc+silver therapy on wound healing of diabetic foot ulcers. EWMA Journal 2010;10(2):83 Abstract 126.

Hanft 2002 {published data only}

Hanft JR, Surprenant MS. Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast‐derived dermis. Journal of Foot and Ankle Surgery 2002;41(5):291‐1.

Jeffery 2008 {published data only}

Jeffery S. A honey‐based dressing for diabetic foot ulcers: a controlled study. Diabetic Foot Journal 2008;11(2):87‐91.

Jensen 1998 {published data only}

Jensen JL, Seeley J, Gillin B. A controlled, randomized comparison of two moist wound healing protocols: Carrasyn hydrogel wound dressing and wet‐to‐moist saline gauze. Advances in Wound Care 1998;11(7 (Suppl)):1‐4.

Kordestani 2008 {published data only}

Kordestani S, Shahrezaee M, Tahmasebi MN, Hajimahmodi H, Ghasemali DH, Abyaneh MS. A randomised controlled trial on the effectiveness of an advanced wound dressing used in Iran. Journal of Wound Care 2008;17(7):323‐7.

Lalau 2002 {published data only}

Lalau JD, Bresson R, Charpentier P, Coliche V, Erlher S, Ha Van G, et al. Efficacy and tolerance of calcium alginate versus Vaseline gauze dressings in the treatment of diabetic foot lesions. Diabetes and Metabolism 2002;28(3):223‐9.
Lalau JD, Samardzic M. Algoderm dressing versus Vaseline gauze for the treatment of diabetic foot lesions. First World Wound Healing Congress; 2000, 10‐13 September; Melbourne, Australia. 2000:96.

Landsman 2010 {published data only}

Landsman A, Agnew P, Parish L, Joseph R, Galiano RD. Diabetic foot ulcers treated with becaplermin and TheraGauze, a moisture‐controlling smart dressing: a randomized, multicenter, prospective analysis. Journal of the American Podiatric Medical Association 2010;100(3):155‐60.

Lazaro‐Martinez 2007 {published data only}

Lázaro‐Martíneza JL, García‐Moralesa E, Aragón‐Sánchezc FJ. Randomized comparative trial of a collagen/oxidized regenerated cellulose dressing in the treatment of neuropathic diabetic foot ulcers. EWMA Journal 2008;8(2 (Suppl)):Poster 371.
Lázaro‐Martíneza JL, García‐Moralesa E, Beneit‐Montesinosa JV, Martínez‐de‐Jesúsb FR, Aragón‐Sánchezc FJ. Randomized comparative trial of a collagen/oxidized regenerated cellulose dressing in the treatment of neuropathic diabetic foot ulcers [Estudio aleatorizado y comparativo de unapósito de colágeno y celulosa oxidadaregenerada en el tratamiento de úlcerasneuropáticas de pie diabético]. Cirugia Espanola 2007;82(1):27‐31.

Lipkin 2003 {published data only}

Lipkin S, Chaikof E, Isseroff Z, Silverstein P. Effectiveness of bilayered cellular matrix in healing of neuropathic diabetic foot ulcers: results of a multicenter pilot trial. Wounds: A Compendium of Clinical Research and Practice 2003;15(7):230‐6.

Markevich 2000 {published data only}

Markevich YO, McLeod‐Roberts J, Mousley M, Melloy E. Maggot therapy for diabetic neuropathic foot wounds. Diabetologia. Northampton, UK, 2000; Vol. 43, issue Suppl 1:A15.

Marston 2001 {published data only}

Marston W, Foushee K, Farber M. Prospective randomized study of a cryopreserved, human fibroblast‐derived dermis in the treatment of chronic plantar foot ulcers associated with diabetes mellitus. 14th Annual Symposium on Advances in Wound Care and Medical Research Forum on Wound Repair; 2001 30 April ‐ 3 May; Las Vegas, Nevada. 2001.

Mazzone 1993 {published data only}

Mazzone T, Blackman JD. Evaluation of a new loaded foam membrane on the healing rate of diabetic foot ulcers. 1st Joint Meeting of the Wound Healing Society and the European Tissue Repair Society; 1993, August; Amsterdam, the Netherlands1993:88.

McCallon 2000 {published data only}

McCallon SK, Knight CA, Valiulus JP, Cunningham MW, McCulloch, Farinas LP. Vacuum‐assisted closure versus saline moistened gauze in the healing of postoperative diabetic foot wounds. Ostomy/Wound Management 2000;46(8):28‐34.

Mody 2008 {published data only}

Mody GN, Nirmal IA, Duraisamy S, Perakath B. A blinded, prospective, randomized controlled trial of topical negative pressure wound closure in India. Ostomy/Wound Management 2008;54(12):36‐46.

Moretti 2009 {published data only}

Moretti B, Notarnicola A, Maggio G, Moretti L, Pascone M, Tafuri S, et al. The management of neuropathic ulcers of the foot in diabetes by shock wave therapy. BMC Musculoskeletal Disorders2009; Vol. 10, issue 54. [DOI: 10.1186/1471‐2474‐10‐54]

Mueller 1989 {published data only}

Mueller MJ, Diamond JE, Sinacore DR, Delitto A, Blair VP, Drury DA, et al. Total contact casting in treatment of diabetic plantar ulcers. Diabetes Care 1989;12(6):184‐8.

Mulder 1994 {published data only}

Mulder GD, Jensen JL, Seeley JE, Peak Andrews K. A controlled randomized study of an amorphous hydrogel to expedite closure of diabetic ulcers. 4th European Tissue Repair Society Meeting; 1994, 25‐28 August; Oxford, England. 1994:130.

Munter 2006 {published data only}

Munter KC, Beele H, Russell L, Basse E, Grochenig E, Crespi A, et al. The CONTOP study: improved healing of delayed healing ulcers with sustained silver‐releasing foam dressing versus other silver dressings. 16th Conference of the European Wound Management Association; 2006, 18‐20 May; Prague, Czech Republic. 2006:210, Abstract No.P068.
Munter KC, Beele H, Russell L, Basse PB, Groechenig E, Crespi A, et al. The CONTOP study: a large‐scale,comparative, randomized study in patients treated with a sustained silver‐releasing foam dressing. SAWC; 30 April‐3 May 2006; San Antonio,Texas. 2006:Poster 11.
Munter KC, Beele H, Russell L, Crespi A, Grocenig E, Basse P, et al. Effect of a sustained silver‐releasing dressing on ulcers with delayed healing: the CONTOP study. Journal of Wound Care 2006;15(5):199‐205.
Russell L, Nebbioso G, Munter KC, Beele H, Basse PB, Dienst H. The Contop study: a hydro‐activated silver containing foam dressing versus standard care. 2nd World Union of Wound Healing Societies Meeting; 2004 ,8‐13 July; Paris. 2004:89.
Scalise A, Forma O, Happe M, Hahn TW. The Contop study: real life experiences from an international study comparing a silver containing hydro‐activated foam dressing with standard wound care. 13th Conference of the European Wound Management Association; 2003, 22‐24 May; Pisa, Italy. 2003:212.

Novinscak 2010 {published data only}

Novinscak T, Zvorc M, Trojko S, Jozinovic E, Filipovic M, Grudic R. Comparison of cost‐benefit of the three methods of diabetic ulcer treatment: dry, moist and negative pressure. Acta Medica Croatica 2010;64(Suppl 1):113‐5.

Palao i Domenech 2008 {published data only}

Palao i Domenech R, Romanelli M, Tsiftsis DD, Slonkova V, Jortikka A, Johannesen N, et al. Effect of an ibuprofen‐releasing foam dressing on wound pain: a real‐life RCT. Journal of Wound Care 2008;17(8):342, 344‐8.

Parish 2009 {published data only}

Parish L, Routh H, Parish J. Diabetic foot ulcers: a randomized multicenter study comparing a moisture‐controlling dressing with a topical growth factor. Journal of the American Academy of Dermatology 2009;60(Suppl 3):AB202.

Pham 1999 {published data only}

Pham HT, Rosenblum BI, Lyons TE, Giurini JM, Chrzan JS, Habershaw GM, et al. Evaluation of a human skin equivalent for the treatment of diabetic foot ulcers in a prospective, randomized, clinical trial. Wounds: A Compendium of Clinical Research and Practice 1999;11(4):76‐86.

Piaggesi 1997 {published data only}

Piaggesi A. A thin hydrocolloid occlusive dressing in diabetic foot ulcerations. Journal of Wound Care 1997;6(3):10.

Reyzelman 2009 {published data only}

Reyzelman A, Crews RT, Moore JC, Moore L, Mukker JS, Offutt S, et al. Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: a prospective, randomised, multicentre study. International Wound Journal 2009;6(3):196‐208.

Roberts 2001 {published data only}

Roberts GH, Hammad LH, Haggan G, Baker N, Sandeman D, Mani R, et al. Hydrocellular against non‐adherent dressings to treat diabetic foot ulcers ‐ a randomised controlled study. 11th European Tissue Repair Society Annual Conference; 2001 5‐8 September; Cardiff, Wales. 2001:50.

Robson 2005 {published data only}

Robson MC, Payne WG, Garner WL, Biundo J, Giacalone VF, Cooper DM, et al. Integrating the results of phase IV(post marketing) clinical trial with four previous trials reinforces the position that Regranex (Becaplermin) gel 0.01% is an effective adjunct to the treatment of diabetic foot ulcers. Journal of Applied Research 2005;5(1):35‐45.

Robson 2009 {published data only}

Robson V, Dodd S, Thomas S. Standardized antibacterial honey (Medihoney) with standard therapy in wound care: randomized clinical trial. Journal of Advanced Nursing  2009 ;65 (3):565‐75.

Sabolinski 2000 {published data only}

Sabolinski M, Giovino K, Graftskin Diabetic Foot Ulcer Study Group. Risk factors associated with the healing of diabetic foot ulcers. Wound Healing Society Educational Symposium; 2000, 4‐6 June; Toronto, Canada. 2000:14.
Sabolinski M, Toole T, Giovino K, Apligraft Diabetic Foot Ulcer Study Group. Apligraf (Graftskin) bilayered living skin construct in the treatment of diabetic foot ulcers. First World Wound Healing Congress; 2000, 10‐13 September; Melbourne, Australia. 2000:68‐9.
Sabolinski ML, Veves A. Graftskin (Apligraf) in neuropathic diabetic foot ulcers. Wounds: A Compendium of Clinical Research and Practice 2000;12(5 (Suppl A)):33A‐6A.
Sabolinski ML, Veves A. Graftskin bilayered living skin construct in the treatment of diabetic foot ulcers. 13th Annual Symposium on Advanced Wound Care and 10th Annual Medical Research Forum on Wound Repair; 2000, 1‐4 April; Dallas, Texas. 2000:C72‐C73.
Veves A, Falango V, Armstrong DG, Sabolinski ML. Graftskin (Apligraf) a human skin equivalent, promotes wound healing in diabetic foot ulcers in a prospective, randomized, multicenter clinical trial. Tenth Annual Meeting of the European Tissue Repair Society; 24–27 May 2000; Brussels, Belgium. 2000.

Sabolinski 2001 {published data only}

Sabolinski M, Falanga V. The healing of diabetic plantar foot ulcers of greater than two‐month duration with Graftskin in a randomized prospective study. Eleventh Annual Meeting and Educational Symposuim Wound Healing Society; 2001, 16‐18 May; Albuquerque, New Mexico. 2001:148.

Shaw 2010 {published data only}

Shaw J, Hughes CM, Lagan KM, Stevenson MR, Irwin CR, Bell PM. The effect of topical phenytoin on healing in diabetic foot ulcers: a randomised controlled trial. Diabetologia 2010;53(Suppl 1):S463.

Shukrimi 2008 {published data only}

Shukrimi A, Sulaiman AR, Halim AY, Azril A. A comparative study between honey and povidone iodine as dressing solution for Wagner type II diabetic foot ulcers. Medical Journal of Malaysia 2008;63(1):44‐6.

Sibbald 2011 {published data only}

Sibbald RG, Coutts P, Woo KY. Reduction of bacterial burden and pain in chronic wounds using a new polyhexamethylene biguanide antimicrobial foam dressing‐clinical trial results. Advances in Skin and Wound Care  2011;24(2):78‐84.

Solway 2011 {published data only}

Solway DR, Clark WA, Levinson DJ. A parallel open‐label trial to evaluate microbial cellulose wound dressing in the treatment of diabetic foot ulcers. International Wound Journal 2011;8(1):69‐73.

Steed 1992 {published data only}

Holloway GA, Steed DL, DeMarco MJ, Matsumoto T, Moosa HH, Webster MW, et al. A randomized controlled multicenter dose response trial of activated platelet supernatant topical CT‐102 in chronic nonhealing diabetic wounds. Wounds: A Compendium of Clinical Research and Practice 1993;5(4):198‐206.
Steed DL. Growth factors in managing diabetic foot ulcers. 5th Annual Symposium on Advanced Wound Care; 1992, 23‐25 April; New Orleans, Lousiana. 1992.
Steed DL, Goslen JB, Holloway GA, Malone JM, Bunt TJ, Webster MW. Randomized prospective double‐blind trial in healing chronic diabetic foot ulcers. Diabetic Care 1992;15(11):1598‐604.

Steed 1995 {published data only}

Steed DL, Ricotta JJ, Prendergast JJ, Kaplan RJ, Webstar MW, McGill JB. Promotion and acceleration of diabetic ulcer healing by arginine‐glycine‐aspartic acid (RGD) peptide matrix. RGD Study Group. Diabetes Care 1995;18(1):39‐46.

Steed 1996 {published data only}

Steed DL, Edington HD, Webster MW. Recurrence rate of diabetic neurotrophic foot ulcers healed using topical application of growth factors released from platelets. Wound Repair and Regeneration 1996;4(2):230‐3.

Subrahmanyam 1993 {published data only}

Subrahmanyam M. Honey as a surgical dressing for burns and ulcers. Indian Journal of Surgery 1993;55(9):468‐73.

Trial 2010 {published data only}

Teot L, Trial C, Lavigne JP. Results of RCT on the antimicrobial effectiveness of a new silver alginate wound dressing. European Wound Management Association Journal 2008;8(Suppl 2):54 Abstract no. 69.
Trial C, Darbas H, Lavigne J. Assessment of the antimicrobial effectiveness of a new silver alginate wound dressing: a RCT. Journal of Wound Care 2010;19(1):20‐6.

Turns 2012 {published data only}

Turns M. Evaluation of NOSF in neuropathic diabetic. Wounds UK 2012;8(1):100‐6.

Urbaneie‐Rovan 1999 {published data only}

Urbaneie‐Rovan V. Efficacy and cost of different dressings. Practical Diabetes International 1999;16(2):S3.

Vandeputte 1997 {published data only}

Vandeputte J, Gryson L. Clinical trial on the control of diabetic foot infection by an immunomodulating hydrogel containing 65% glycerine. Proceedings of the 6th European Conference on Advances in Wound Management; 1‐4 October, 1996; Amsterdam. 1996:50‐3.
Vandeputte J, Gryson L. Diabetic foot infection controlled by immuno‐modulating hydrogel containing 65% glycerine. Personal Communication: Presentation of a clinical trial.1996.

Varma 2006 {published data only}

Varma AK, Bal A, Kumar H, Kesav R, Nair S. Efficacy of polyurethane foam dressing in debrided diabetic lower limb wounds. Wounds: A Compendium of Clinical Research and Practice 2006;18(10):300‐6.

Veves 2001 {published data only}

Veves A, Falanga V, Armstrong DG, Sabolinski ML. Graftskin, a human skin equivalent, is effective in the management of neuropathic diabetic foot ulcers. Diabetes Care 2001;24(2):290‐5.

Veves 2002 {published data only}

Sheehan P, Jones P,   Caselli A, Giurini JM, Veves A. Percent change in wound area of diabetic foot ulcers over a 4‐week period is a robust predictor of complete healing in a 12‐week prospective trial. Diabetes Care  2003;26(6):1879‐82.
Veves A. Promogran clinical trial. The Diabetic Foot 2001;4(4):S4‐S5.
Veves A. Wound care device expert meeting. Summary report. Promogran ‐ clinical trial data. The Diabetic Foot  2001;4(3):S8‐S10.
Veves A, Sheehan P, Pham HT. A randomized controlled trial of Promogran (a collagen / oxidised regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers. Archives of Surgery 2002;137:822‐7.

Whalley 2001 {published data only}

Capillas R, Whalley A, Boulton AMJ, Dargis V, Harding K, Van Acker K. Performance characteristics and safety of hydrogels using a non‐adhesive foam dressing as secondary dressing in the treatment of diabetic foot ulcers. 12th Conference of the European Wound Management Association;2002, 23‐25 May; Granada, Spain. 2002:261.
Whalley A, Boulton AJM, Dargis V, Harding K, Van Acker K, Capillas R. Characteristics of the efficacy and safety of a hydrogen using a hydropolymer as the secondary dressing in the treatment of ulcers of the diabetic foot. 12th Conference of the European Wound Management Association;2002, 23‐25 May; Granada, Spain. 2002:322.
Whalley A, Boulton AJM, Dargis V, Harding K, Van Acker K, Capillas R. Performance characteristics and safety of Purilon gel versus Intrasite using Biatain non‐adhesive dressing as secondary dressing in the treatment of diabetic foot ulcers. 11th European Tissue Repair Society Annual Conference; 2001 5‐8 September; Cardiff, Wales. 2001:49.

Woo 2010 {published data only}

Woo K, Sibbald G, Coutts P. Reduction of infection and pain in chronic wounds using a new antimicrobial foam dressing. EWMA Journal 2010;10(2):59 Abstract 78.

Yao 2007 {published data only}

Yao XZ, Chen W. Effectiveness of feet soaking with Chinese herbs combined with changing dressings in the treatment of diabetic foot ulceration. Journal of Nursing Science 2007;22(5):42‐3.

Zimny 2003 {published data only}

Zimny S, Schatz H, Pfohl U. The effects of applied felted foam on wound healing and healing times in the therapy of neuropathic diabetic foot ulcers. Diabetic Medicine 2003;20(8):622‐5.

References to studies awaiting assessment

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Ogce 2007 {published data only}

Ogce F, Dramali A. The treatment of diabetic foot ulcers. Sendrom 2007;19(12):79‐81.

Additional references

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Abbott 2002

Abbott CA, Carrington AL, Ashe H, Bath S, Every LC, Griffiths J, et al. The North West Diabetes Foot Care Study: incidence of and risk factors for, new diabetic foot ulceration in a community‐based patient cohort. Diabetic Medicine 2002;19:377‐84.

Apelqvist 2000a

Apelqvist J, Bakker K, van Houtum WH, Nabuurs‐Franssen MH, Schaper NC. International consensus and practical guidelines on the management and the prevention of the diabetic foot: International Working Group on the Diabetic Foot. Diabetes Metabolism Research and Review 2000;16(Suppl 1):S84‐92.

Apelqvist 2000b

Apelqvist J, Larsson J. What is the most effective way to reduce incidence of amputation in the diabetic foot?. Diabetes Metabolism Research and Reviews 2000;16(Suppl 1):S75‐83.

Becker 2011

Becker LA, Oxman AD. Chapter 22: Overviews of reviews. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

Bergin 2006

Bergin SM, Wraight P. Silver based wound dressings and topical agents for treating diabetic foot ulcers. Cochrane Database of Systematic Reviews 2006, Issue 1. [DOI: 10.1002/14651858.CD005082.pub2]

BNF 2010

British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary Appendix 8: Wound management products and elastic hosiery. http://www.bnf.org.uk/bnf/bnf/current Sept 2010;60.

Cardinal 2009

Cardinal M, Eisenbud DE, Armstrong DG, Zelen C, Driver V, Attinger C, et al. Serial surgical debridement: a retrospective study on clinical outcomes in chronic lower extremity wounds. Wound Repair and Regeneration 2009;17(3):306‐11.

Currie 1998

Currie CJ, Morgan CL, Peters JR. The epidemiology and cost of inpatient care for peripheral vascular disease, infection, neuropathy, and ulceration in diabetes. Diabetes Care 1998;21(1):42‐8.

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Murray HJ, Young MJ, Hollis S, Boulton AJ. The association between callus formation, high pressures and neuropathy in diabetic foot ulceration. Diabetic Medicine 1996;13:979‐82.

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

Jump to:

Clever 1995

Methods

RCT (not clear if single‐centre or multi‐centred) comparing a foam dressing (Allevyn, Smith & Nephew) with a hydrocolloid (polyurethane matrix) dressing (Cutinova Hydro, S&N Hlth, previously Beiersdorf) undertaken in Germany
Duration of follow up: until healing occurred or for a maximum of 16 weeks

Participants

40 participants
Inclusion criteria: patients aged 18 to 80 years with a pure neuropathic superficial ulcer 1 to 5 cm in diameter and with no clinical and radiological signs of osteomyelitis or tendon involvement
Exclusion criteria: patients with an ankle‐brachial pressure index < 0.8 (measured using doppler ultrasound) and with clinical or radiological signs of osteomyelitis or tendon involvement. Ulcers requiring topical treatment were also excluded, as were patients with know allergies to any product being used.

Interventions

Group A (n = 20): hydrocolloid (polyurethane matrix) dressing (Cutinova Hydro, Smith & Nephew)

Group B (n = 20): foam dressing (Allevyn, Smith & Nephew)
In both groups, dressing changes were performed as often as required but at least once a week
Co‐intervention: pressure relief comprising a half‐shoe or so‐called 'heal sandal', therapeutic footwear with cushioned insoles, and crutches as required to meet individual needs, infection control with systemic antibiotics if required, wound cleansing with Ringer's solution and debridement with removal of callus if needed

Outcomes

Primary outcome: ulcer healing (number of ulcers healed; mean time to healing; median time to healing; wound size)

Secondary outcomes: adverse events (number); costs (mean number of dressing changes between clinical visits)
Health‐related quality of life; amputations and ulcer recurrence not reported

Notes

Trial data: Analysis 5.1

Funding source: Beiersdorf AG, Hamburg

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote:"Conducted an open, randomised, controlled study"
Comment: method of generation of random schedule not reported

Allocation concealment (selection bias)

Unclear risk

Comment: the process of randomising participants, including who did this is not reported

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Quote: "Conducted an open, randomised, controlled study"
Comment: the trial was stated as being open‐labelled. No other details in the text

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Quote:"Conducted an open, randomised, controlled study"
Comment: this was labelled an open trial not clear if blinded evaluation was conducted.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Comment: in total 6 participants were withdrawn, or 15% of the total study population. The study report also states that withdrawals were excluded from the analyses.

Selective reporting (reporting bias)

Low risk

Comment: based on paper only, protocol not obtained

Other bias

Unclear risk

Comment: funded by commercial organisation

Jeffcoate 2009

Methods

Three‐armed RCT comparing an iodine‐impregnated dressing (Inadine, Johnson and Johnson) and fibrous‐hydrocolloid (hydrofibre) dressing (Aquacel, ConvaTec) with a non‐adherent dressing, viscose filament gauze (Johnson & Johnson) undertaken in the UK
Duration of follow up: ulcers once healed were followed bi‐weekly for 4 weeks  to ensure they remained healed. Ulcers that recurred within the 4 weeks were regarded as unhealed and continued in the study. All participants with healed ulcers were re‐assessed by the clinicians in charge of their care 12 weeks after healing to assess for recurrence. Patients with persistent ulcers were assessed by clinicians in charge by 24 weeks and withdrawn from the intervention phase at that time. They did attend for a final assessment 36 weeks after recruitment.  

Participants

317 participants
Inclusion criteria: patients with Type 1 or 2 diabetes, aged 18 years or more having a foot ulcer present for at least 6 weeks. Ulcer cross‐sectional area of between 25 and 2500 mm2. Able and willing to give informed consent. Reasonably accessible by car to the hospital base and under routine review by the multidisciplinary clinic. If there was more than one ulcer on the foot, the largest ulcer that conformed to the inclusion criteria was selected as the index ulcer.       
Exclusion criteria: patients with a known allergy to any of the trial preparations (including iodine). Any ulcer on either foot extending to tendon, periosteum or bone. Patients with infection of the bone, soft tissue infection requiring treatment with systemic antibiotics. An ulcer on a limb being considered for revascularisation. Ulcers chosen for management with a non‐removable cast without a dressing window. Gangrene on the affected foot. Eschar which was not removable by clinical debridement. Patients with evidence of a sinus or deep track. Patients in whom the hallux had been amputated on the affected side (preventing the measurement of toe pressure). Those with an ankle:brachial pressure index of less than 0.7 or toe systolic pressure less than 30 mmHg. Ulceration judged to be caused primarily by disease other than diabetes. Patients with any other serious disease likely to compromise the outcome of the trial. Patients with critical renal disease (creatinine greater than 300 mmol/l) and those receiving immunosuppressants, systemic corticosteroid therapy (other than by inhalation) or any other preparation which could, in the opinion of the supervising clinician, have interfered with wound healing. Patients living at such a distance (generally further than 10 miles) from the clinic as would have made frequent assessment visits inappropriately expensive and/or impractical. Patients who withheld consent.

Interventions

Group A (n = 103): fibrous‐hydrocolloid (hydrofibre) dressing (Aquacel, ConvaTec)

Group B (n = 108): iodine‐impregnated dressing (Inadine, Systagenix)
Group C (n = 106): non‐adherent dressing, viscose filament gauze (Johnson & Johnson)  
For all groups, patients and carers were shown the dressing to be used and asked if they wished to change their own dressings (either entirely or just on some occasions), but with fortnightly monitoring by a trial nurse. Those who wished to do so received further training to ensure the dressings were applied correctly. Those who chose not to be responsible for this aspect of their care had their dressings changed by the district nurse or practice nurse, according to usual procedure, or by the trial nurse. Dressings were changed daily, on alternate days or 3 times a week according to need and/or availability of professional staff.  
Co‐intervention: ulcer management was in line with current guidelines for good practice, including appropriate and regular use of debridement and with a removable fibreglass or polyester boot being recommended for off‐loading. Participants were advised to have a bath or shower as often as they wished provided the ulcer could be redressed afterwards, and provided the ulcerated foot was not immersed in water for more than 5 minutes.    

Outcomes

Primary outcome: ulcer healing (number of ulcers healed at 24 weeks; mean time to healing in days)
Secondary outcomes: health‐related quality of life (Mean Cardiff Wound Impact Schedule score); amputations (minor and major); adverse events (serious and non‐serious); cost (cost per patient); ulcer recurrence

Notes

Trial data: Analysis 5.1

In total, 88 were withdrawn from this study. The study methods note that an ITT analysis for % healed was conducted using last entry carried forward, with participants only considered healed if this was confirmed after 4 weeks. Thus, the analysis assumed that those withdrawn did not heal (they are in denominator but not the numerator)
Funding source: non‐commercial organisation (United Kingdom National Health Service Health Technology Assessment Programme)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote:"Randomisation lists were created using SPSS (SPSS Inc., Version 14), using blinded dressing codes "
Comment: method of generation of random schedule reported

Allocation concealment (selection bias)

Low risk

Quote:"using blinded dressing codes. The lists were held at Cardiff University and each recruiting centre telephoned a designated number during working hours"
Comment: central allocation using telephone

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Quote:"The nurse was not blinded to the randomisation and dressed the wound at the end of the visit"
Comment: no mention about blinding of participants. Healthcare providers were not blinded.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Quote:"Dressings were removed prior to the examination by investigators who were not involved in the conduct of the trial and who were blind to the randomisation group."
Comment: outcome assessors were blinded

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Quote:"Intention to treat analysis was carried out using the last value carried forward method, with strict adherence to the protocol such that only those who attended for a healing verification visit and reported as still healed at 28 days have been coded as ‘healed’ for the outcome classification."
Comment: ITT analysis was done but imputing missing data due to withdrawal of trial participants due to adverse events and protocol violations

Selective reporting (reporting bias)

Low risk

Comment: based on full report, protocol not obtained

Other bias

Low risk

Comment: funded by non‐commercial organisation (UK Health Technology Assessment Programme)

Jude 2007

Methods

Multi‐centred, 2‐armed trial, RCT comparing a fibrous‐hydrocolloid (hydrofibre) dressing with 1.2% ionic silver (Aquacel Ag, ConvaTec) with a calcium‐alginate dressing (Algosteril, Smith & Nephew) undertaken in the UK, France, Germany, Sweden
Duration of follow up: 8 weeks

Participants

134 participants
Inclusion criteria: patients with type 1 or type 2 diabetes mellitus (HbA1c ≤ 12%), serum creatinine ≤ 200 mol/l diabetic foot ulcers classed as Wagner grade 1 or 2 and of neuropathic or neuro‐ischaemic aetiology. All wounds > 1 cm2 in area.     
Exclusion criteria: patients with known allergies to dressings under study; if there was a known or suspected malignancy near ulcer. Also, if patient had been on systemic antibiotics > 7 days prior to enrolment or with inadequate arterial perfusion as defined by ankle‐to‐brachial index < 0.8, great toe systolic blood pressure < 40 mmHg or forefoot TcPO2 < 30 mmHg (subject supine) or < 40 mmHg (subject sitting)

Interventions

Group A (n = 67): fibrous‐hydrocolloid (hydrofibre) dressing with 1.2% ionic silver (Aquacel® Ag, ConvaTec). Left in place and changed on leakage or at evaluation or every 7 days as indicated.        
Group B (n = 67): calcium‐alginate dressing (Algosteril, Smith & Nephew). Manufacturers instructions were followed and the dressing was moistened before use on dry wounds and changed on leakage or at evaluation or every 7 days as indicated (except if the wound was infected when dressed changed daily).                       
In both groups, ulcers were cleansed using sterile saline, each dressing was covered with a sterile, non‐adherent foam dressing
Co‐intervention: accommodative footwear for non‐plantar ulcers and off‐loading for planter ulcers was delivered as required. 

Outcomes

Primary outcome: ulcer healing (number of ulcers healed; velocity of healing; mean time in days to healing; reduction in ulcer area; reduction in ulcer depth)

Secondary outcomes: adverse events (number); costs (mean number of dressing changes)
Health‐related quality of life; amputations and ulcer recurrence not reported

Notes

Trial data: Analysis 5.1

22 participants had clinically infected ulcers at baseline, 9 in Group A and 13 in Group B . On enrolment antibiotics were prescribed to 13 in Group A and 8 in Group B.
Funding source: ConvaTec (Bristol Myers Squibb)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote:"Individuals were randomly assigned to receive either ** or ** dressings according to instructions in a sealed envelope and stratified according to whether or not systemic antibiotics were being administered for treatment of the study ulcer"
Comment: method of generation of random schedule not clear from this description

Allocation concealment (selection bias)

Unclear risk

Comment: not clear if envelopes were sequentially numbered, opaque and sealed 

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: no mention of blinding in study report

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: no mention of blinding in study report

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: 21 participants recorded as discontinuing treatment, however, it does not seem like these were study withdrawals. All randomised included in the analysis.

Selective reporting (reporting bias)

Low risk

Comment: based on study report, protocol not obtained

Other bias

Unclear risk

Comment: funded by commercial organisation

Kuo 2012

Methods

2‐arm trial, RCT comparing a fibrous‐hydrocolloid (hydrofibre) dressing with a topical cream containing P. amboinicus (Lour.) Spreng. (Lamiaceae) and C. asiatica (L.) Urban (Umbelliferae) undertaken in Taiwan.

Duration of follow up: 2 weeks. After two weeks, the wounds in both groups were all reconstructed by split‐thickness skin graft or primary closure.

Participants

24 participants
Inclusion criteria: Inclusion criteria were patients with type 1 or type 2 diabetes, aged 20 years or older, and having Wagner
grade 3 foot ulcers postsurgical debridement. Wagner grade 3 was defined as “deep ulcer involving osteitis, abscess, or
osteomyelitis”.
Exclusion criteria: Patients with poor nutritional status (albumin <3 g/dL), poor diabetic control (HbA1c >10%), anaemia (hemoglobin <10 g/dL), and leukocyte counts <1,000/cu mm; presence of connective tissue disease; known or suspected malignancy local to the study ulcer; renal failure insufficiency (serum creatinine >1.5mg/dL) or abnormal liver function (AST, ALT >2.5 × upper limit of normal range); requiring treatment with immunosuppressive agents, corticosteroids, chemotherapy or radiotherapy; female patients with positive pregnancy test or breastfeeding or unwilling to use appropriate contraceptive methods during study; patients with known sensitivity to essential oils or lanolin cream.

Interventions

Group A (n = 12): fibrous‐hydrocolloid (hydrofibre) dressing (Aquacel ConvaTec, Valencia, CA, USA). Hydrocolloid fiber dressing group and left in place for up to 7 days or changed earlier as clinically indicated.
Group B (n = 12): cream contained extracts from two botanical raw materials, P. amboinicus and C. asiatica. The plants of
P. amboinicus were collected on 2007 according to good agricultural and good collection practices. C. asiatica. extract
was sourced commercially with certificate of analysis of the extract and herbal material. the most active fractions from P. amboinicus and from C. asiatica, were combined in a 1 : 4 ratio to form the drug substance. The final cream, contained
1.25% of drug substance in a cream base, 15 g per tube. The cream base contained cetostearyl alcohol, ireine, liquid
petrolatum, methyl paraben propyl paraben, Span 60, Tween 60, white petrolatum, water, and pigments.

The cream was applied topically twice daily in an amount to fully cover the ulcer area in a thin and even layer (not exceed 2 millimetres in thickness).

In both groups, After applying cream or fibrous‐hydrocolloid dressing, the wound was covered with a transparent, adhesive, waterproof dressing (Opsite, Smith & Nephew, Taipei, Taiwan). After two weeks, the wounds in both groups were all reconstructed by split‐thickness skin graft or primary closure.

Co‐intervention: sharp surgical debridement (including resection of necrotic soft tissue and bone, sinus tracts,
fistulae, undermined borders, callus) to form viable wound margins was performed before randomization and repeated
as needed during the dosing period. Systemic antimicrobial agents were allowed for treatment of infections. Nonweight
bearing or offloading was required for all subjects. Prohibited treatments during the study period included
immunosuppressive agents, corticosteroids, chemotherapy and radiotherapy.

Outcomes

Primary outcome: Percent change in wound size

Secondary outcomes: Adverse event (no. of participants with at least one adverse event).

Notes

Trial data: Analysis 5.1
Funding source: No details

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: Treatment allocation was performed before site initiation. Permuted‐block treatment allocation was used to assign participants to each group. A list of sequential numbers was generated using a permuted‐block randomization procedure with a block size of 4 in SAS 9.1, with each number randomly
assigned to one group.

Comment: Adequate

Allocation concealment (selection bias)

Unclear risk

Quote: "Patients meeting the inclusion and exclusion criteria were randomly assigned in a 1:1 ratio to the WH‐1 cream group or the hydrocolloid fiber dressing group according to a predefined randomization schedule"

Comment: No mention of how the randomisation sequence was implemented

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: No mention of blinding in report

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Comment: No mention of blinding in report

Incomplete outcome data (attrition bias)
All outcomes

High risk

Comment: 24 participants were randomised and 21 were included in the analysis: the 3 exclusions represent 12.5% of the total sample size. Classed as high risk of bias.

Selective reporting (reporting bias)

Low risk

No evidence. Healed wounds were not planned in this study.

Other bias

Unclear risk

Possibility some baseline imbalance perhaps due to the small sample size.
Piaggesi 2001

Methods

Single‐centred, 2‐armed RCT comparing a fibrous‐hydrocolloid (hydrofibre) dressing (Aquacel, ConvaTec) with saline moistened gauze undertaken in Italy
Duration of follow up: patients were followed until complete re‐epithelialisation occurred. Maximum calculated by review authors as approximately 350 days. 

Participants

20 participants
Inclusion criteria: diabetic patients (type 1 or type 2) for over 5 years, between age 18 to 75 years, foot ulcer more than 3 weeks, > 1 cm wide and 1 cm deep, good peripheral blood supply (palpable peripheral pulses or ABPI > 0.9). Ulcers were due to diabetic neuropathy, or surgical drainage of a previous infection or both.
Exclusion criteria: active infection documented by clinical local (redness, swelling, tenderness, purulent discharge, odour) or systemic (fever, malaise, leukocytosis) and confirmed with culture exams. Serum creatinine > 2 mg/dl, recent episodes of ketoacidosis, malignancies and any systemic therapy or chronic pathology which could obstruct the healing process.  

Interventions

Group A (n = 10): fibrous‐hydrocolloid (hydrofibre) dressing (Aquacel, ConvaTec); dressing changed every second or third day, depending on the extent of wound exudate
Group B (n = 10): saline‐moistened gauze; dressing renewed twice a day with saline to prevent drying out
Both trial dressings were covered by several layers of gauze
Co‐interventions: participants received special postoperative shoes to relieve the pressure from the ulcerated foot. Participants were trained to walk with crutches until there was satisfactory healing.   

Outcomes

Primary outcome: ulcer healing (number of ulcers healed; healing time in days; median % reduction in lesion volume; median % of granulation tissue)
Secondary outcomes: amputation; adverse events; cost/resource use (average number of days between dressings changes)
Health‐related quality of life and ulcer recurrence not reported

Notes

Trial data: Analysis 5.1

Study authors have also reported the results for healing time excluding the patients suffering from infection (NOT extracted)
Funding source: grant from Italian health board (Ministero della Sanita: Ricerca Finalizzata 1999 ‐ Convenzione no. RF 99.52). Dressing material and devices were supplied by the hospital during the study as part of the routine therapy: manufacturers were not involved in any part of the experiment.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote:"Patients were randomly sorted into two different groups using a computer ‐generated list".
Comment: method of generation of random schedule reported

Allocation concealment (selection bias)

Unclear risk

Comment: the process of randomising participants, including who did this is not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: no mention of blinding in study report

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Quote:"After 8 weeks patients were blindly evaluated by one of the authors (M.R) for rate of RVL and rate of GT".
Comment: it is not clear if healing assessment was blinded

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: no indication of incomplete outcome data in paper

Selective reporting (reporting bias)

Low risk

Comment: based on study report, protocol not obtained

Other bias

Low risk

Comment: funded by non‐commercial organisation

ABPI: ankle brachial pressure index
ITT: intention‐to‐treat
RCT: randomised controlled trial

Characteristics of excluded studies [ordered by study ID]

Jump to:

Study

Reason for exclusion

Agas 2006

Study did not randomise participants

Ahroni 1993

The dressing groups evaluated in this study were not hydrocolloid dressings

Altman 1993

No single, identifiable dressing type evaluated.

Alvarez 2003

The dressing groups evaluated in this study were not hydrocolloid dressings

Apelqvist 1990

Relevant outcome data are not reported: study outcome was limited to change in size of necrotic material on the wound. Study authors were unable to provide the original healing outcome data.

Apelqvist 1996

No single, identifiable dressing type evaluated.

Apelqvist 2004

No single, identifiable dressing type evaluated.

Armstrong 2004

No single, identifiable dressing type evaluated.

Baker 1993

The dressing groups evaluated in this study were not hydrocolloid dressings

Belcaro 2010

The dressing groups evaluated in this study were not hydrocolloid dressings

Blackman 1994

The dressing groups evaluated in this study were not hydrocolloid dressings

Bogaert 2004

Study did not randomise participants

Bradshaw 1989

Trial stopped after recruiting six participants. No data presented. Authors not contacted for healing data.

Caravaggi 2003

Other intervention, not dressings, differs between trial arms

Chang 2000

Study did not include diabetic foot ulcers

Chauhan 2003

Other intervention, not dressings, differ between trial arms

Chirwa 2010

Study did not randomise participants

Cuevas 2007

No single, identifiable dressing type evaluated.

D'Hemecourt 1998

The dressing groups evaluated in this study were not hydrocolloid dressings

Dash 2009

Other intervention, not dressings, differ between trial arms

Diehm 2005

Study did not randomise participants

Donaghue 1998

The dressing groups evaluated in this study were not hydrocolloid dressings

Driver 2006

Other intervention, not dressings, differs between trial arms

Edmonds 2009

Other intervention, not dressings, differs between trial arms

Eginton 2003

No single, identifiable dressing type evaluated.

Etoz 2003

Study did not randomise participants

Farac 1999

Author contacted: study not suitable for inclusion due to data quality issues

Foo 2004

The dressing groups evaluated in this study were not hydrocolloid dressings

Foster 1994

The dressing groups evaluated in this study were not hydrocolloid dressings

Foster 1999

Other intervention, not dressings, differs between trial arms

Gao 2007

Other intervention, not dressings, differs between trial arms

Gentzkow 1996

Other intervention, not dressings, differs between trial arms

Gottrup 2011

The dressing groups evaluated in this study were not hydrocolloid dressings

Hanft 2002

Other intervention, not dressings, differs between trial arms

Jeffery 2008

Study did not randomise participants

Jensen 1998

The dressing groups evaluated in this study were not hydrocolloid dressings

Kordestani 2008

The dressing groups evaluated in this study were not hydrocolloid dressings

Lalau 2002

The dressing groups evaluated in this study were not hydrocolloid dressings

Landsman 2010

Other intervention, not dressings, differs between trial arms

Lazaro‐Martinez 2007

No single, identifiable dressing type evaluated.

Lipkin 2003

Other intervention, not dressings, differs between trial arms

Markevich 2000

The dressing groups evaluated in this study were not hydrocolloid dressings

Marston 2001

Other intervention, not dressings, differs between trial arms

Mazzone 1993

The dressing groups evaluated in this study were not hydrocolloid dressings

McCallon 2000

Study did not randomise participants

Mody 2008

Study did not include diabetic foot ulcers

Moretti 2009

Other intervention, not dressings, differs between trial arms

Mueller 1989

Other intervention, not dressings, differs between trial arms

Mulder 1994

The dressing groups evaluated in this study were not hydrocolloid dressings

Munter 2006

The dressing groups evaluated in this study were not hydrocolloid dressings

Novinscak 2010

No single, identifiable dressing type evaluated.

Palao i Domenech 2008

The dressing groups evaluated in this study were not hydrocolloid dressings

Parish 2009

Other intervention, not dressings, differs between trial arms

Pham 1999

Other intervention, not dressings, differs between trial arms

Piaggesi 1997

Study did not randomise participants

Reyzelman 2009

No single, identifiable dressing type evaluated.

Roberts 2001

The dressing groups evaluated in this study were not hydrocolloid dressings

Robson 2005

Other intervention, not dressings, differs between trial arms

Robson 2009

Study did not include diabetic foot ulcers

Sabolinski 2000

Other intervention, not dressings, differs between trial arms

Sabolinski 2001

Other intervention, not dressings, differs between trial arms

Shaw 2010

Other intervention, not dressings, differs between trial arms

Shukrimi 2008

Other intervention, not dressings, differs between trial arms

Sibbald 2011

The dressing groups evaluated in this study were not hydrocolloid dressings

Solway 2011

Study did not randomise participants

Steed 1992

Other intervention, not dressings, differs between trial arms

Steed 1995

Other intervention, not dressings, differs between trial arms

Steed 1996

Other intervention, not dressings, differs between trial arms

Subrahmanyam 1993

The dressing groups evaluated in this study were not hydrocolloid dressings

Trial 2010

The dressing groups evaluated in this study were not hydrocolloid dressings

Turns 2012

Study did not randomise participants

Urbaneie‐Rovan 1999

No single, identifiable dressing type evaluated.

Vandeputte 1997

The dressing groups evaluated in this study were not hydrocolloid dressings

Varma 2006

No single, identifiable dressing type evaluated.

Veves 2001

Other intervention, not dressings, differs between trial arms

Veves 2002

The dressing groups evaluated in this study were not hydrocolloid dressings

Whalley 2001

The dressing groups evaluated in this study were not hydrocolloid dressings

Woo 2010

The dressing groups evaluated in this study were not hydrocolloid dressings

Yao 2007

Other intervention, not dressings, differs between trial arms

Zimny 2003

Other intervention, not dressings, differs between trial arms

Characteristics of studies awaiting assessment [ordered by study ID]

Jump to:

Ogce 2007

Methods

Participants

Interventions

Outcomes

Notes

Translation required

Data and analyses

Open in table viewer
Comparison 1. Fibrous‐hydrocolloid (hydrofibre) dressing compared with basic wound contact dressing

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of ulcers healed Show forest plot

2

229

Risk Ratio (M‐H, Random, 95% CI)

1.01 [0.74, 1.38]
Analysis 1.1
Comparison 1 Fibrous‐hydrocolloid (hydrofibre) dressing compared with basic wound contact dressing, Outcome 1 Number of ulcers healed.

Comparison 1 Fibrous‐hydrocolloid (hydrofibre) dressing compared with basic wound contact dressing, Outcome 1 Number of ulcers healed.

Open in table viewer
Comparison 2. Hydrocolloid (matrix) dressing compared with foam dressing

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of ulcers healed Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only
Analysis 2.1
Comparison 2 Hydrocolloid (matrix) dressing compared with foam dressing, Outcome 1 Number of ulcers healed.

Comparison 2 Hydrocolloid (matrix) dressing compared with foam dressing, Outcome 1 Number of ulcers healed.

Open in table viewer
Comparison 3. Silver hydrocolloid dressing compared with alginate dressing

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of ulcers healed Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only
Analysis 3.1
Comparison 3 Silver hydrocolloid dressing compared with alginate dressing, Outcome 1 Number of ulcers healed.

Comparison 3 Silver hydrocolloid dressing compared with alginate dressing, Outcome 1 Number of ulcers healed.

Open in table viewer
Comparison 4. Iodine‐impregnated dressing compared with fibrous‐hydrocolloid (hydrofibre) dressing

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of ulcers healed Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only
Analysis 4.1
Comparison 4 Iodine‐impregnated dressing compared with fibrous‐hydrocolloid (hydrofibre) dressing, Outcome 1 Number of ulcers healed.

Comparison 4 Iodine‐impregnated dressing compared with fibrous‐hydrocolloid (hydrofibre) dressing, Outcome 1 Number of ulcers healed.

Open in table viewer
Comparison 5. Trial data

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Trial data Show forest plot

Other data

No numeric data
Analysis 5.1

Study

Groups

Primary outcome: ulcer healing

Secondary: health‐related quality of life

Number and level of amputations

Adverse events, including pain

Cost

Ulcer recurrence

Heading 8

Clever 1995

Group A (n = 20): Hydrocolloid (polyurethane matrix) dressing

Group B (n = 20): Foam dressing

Number of ulcers healed:
Group A: 16

Group B: 14
Mean time to healing in days (SD)
Group A: 25.19 (23.52)

Group B: 20.43 (14.74)
Median time to healing in days
Group A: 15.5 (range 4 to 76)

Group B: 16.5 (range 4 to 52)
Wound size at 4 weeks mm2 (SD):
Group A: 32.37 (54.12)

Group B: 33.46 (75.22)

n/r

n/r

(Reasons not reported separately for 2 groups):
Group A: 1

Group B: 5

Mean number of dressing changes between clinical visits (SD):
Group A: 2.23 (2.19)

Group B: 2.37 (2.18)

n/r

Jeffcoate 2009

Group A (n = 103): Fibrous‐hydrocolloid

(hydrofibre) dressing

Group B (n = 108): Iodine‐impregnated dressing
Group C (n = 106): non‐adherent dressing, viscose filament gauze

Number of ulcers healed at 24 weeks:
Group A: 46

Group B: 48
Group C: 41
Mean time to healing in days (SD) (fixed at max of 168 days)
Group A: 125.8 (55.9)

Group B: 127.8 (54.2)
Group C  130.7 (52.4)

Mean Cardiff Wound Impact Schedule score at 24 weeks (SD)

Group A: Physical functioning: 71.4 (19.5).  Social functioning: 70.3 (25.4). Well being: 53.1 (19.9)
Group B: Physical functioning: 67.1 (23.6).  Social functioning: 69.7 (24.1). Well being: 51.0 (22.3) 
Group C: Physical functioning: 68.9 (19.1).  Social functioning: 69.8 (23.5). Well being: 50.2 (21.1) 
Other
Study also reports mean and SD for each of the eight domains of the SF‐36. No significant different between the groups for any domain.

Minor amputations (Below ankle):
Group A: 3
Group B: 1
Group C: 1
Major amputations (Above knee)
Group A: 1
Group B: 0
Group C: 1

Non‐serious adverse events
Group A: 227

Group B: 239
Group C: 244
Serious adverse events
Group A: 28

Group B: 37
Group C: 35

Cost in GBP per patient for dressing management:
Mean (95% CI)

Group A: 191.33 (148.41 to 234.25)
Group B: 183.60 (128.92 to 238.21)
Group C: 141.18 (108.18 to 174.17)
Cost in GBP of professional time in managing foot ulcers: Mean (95% CI)

Group A: 459.87 (354.78 to 564.97)
Group B: 556.90 (422.32 to 691.48)
Group C: 448.86 (348.68 to 549.03
Cost in GBP of generating a healed ulcer using non‐adherent dressing (Group C): 362.

Cost in GBP of generating an additional healed ulcer:

Group A: 836

Group B: 848

At same site
Group A: 3
Group B: 7
Group C: 3

Jude 2007

Group A (n = 67): Fibrous‐hydrocolloid (hydrofibre) dressing with 1.2% ionic silver  
Group B (n = 67): Calcium‐alginate dressing

Number of ulcers healed in 8 weeks
Group A: 21
Group B: 15
Velocity of healing cm2/week (SD):
Group A: 0.29 (0.33) (n = 61)
Group B: 0.26 (0.90) (n = 61)
Velocity of healing as % per week (SD):
Group A: 11.6 (17.7) (n = 61)   
Group B: 10.0 (15.5)  (n = 61)                 
Mean time in days to healing (SD):
Group A: 52.6 (1.8)       
Group B: 57.7 (1.7)                                                                
Reduction in ulcer area in 8 weeks:
Group A: 58.1 (53.1).
Group B: 60.5 (42.7). 
Reduction in ulcer depth (cm) at 8 weeks (SD):
Group A:  0.25 (0.49)   
Group B:  0.13 (0.37)   


                              

n/r

n/r

Group A: 25 participants experienced one or more events. Death = 1; Infection = 14. 8 participants discontinued treatment due to AE.                                            
Group B: 26 participants experienced adverse event. Death = 1; Infection = 8. 13 participants discontinued treatment due to AE.                 

Mean number of dressing changes during study:
Group A: 21.9    
Group B: 20.8   

n/r

Kuo 2012

Group A (n = 12): fibrous‐hydrocolloid (hydrofibre) dressing
Group B (n = 12): cream contained extracts from two botanical raw materials, P. amboinicus and C. asiatica.

Percent change in wound size (from baseline ‐ assumed to 14 days).

Median and (IQR)

Group A: ‐22.64 (‐36.90 to ‐3.20)

Group B: ‐ 27.18(‐38.86 to 36.10)

Reported in paper as not statistically significant from Mann‐Whitney U test. P = 0.673

n/r

n/r

Number of people with one or more adverse events

Group A: 5/12 (41.7%)

Group B: 5/12 (41.7%)

Piaggesi 2001

Group A (n = 10): Fibrous‐hydrocolloid

(hydrofibre) dressing
Group B (n = 10): Saline‐moistened gauze dressing

Number of ulcers healed (during period of study):
Group A: 9
Group B: 10
Healing time in days (mean) (SD)
Group A: 127 (46 days)
Group B: 234 (61 days) 
Median % reduction in lesion volume at 8 weeks follow up (interquartile range):
Group A: 50 (26)           
Group B: 35 (15) 
Median % of granulation tissue at 8 weeks follow up (interquartile range)
Group A: 60 (40)               
Group B: 32.5 (10)                       

    

n/r

Group A: Amputation of a lesser toe = 3; Amputation of 2 lesser toes = 1; Metatarsal resection = 1
Group B: Amputation of a lesser toe = 2; Metatarsal resection = 1

Group A: Maceration of peri‐lesional skin = 1; Infective complications = 1
Group B: Maceration of peri‐lesional skin = 2; Infective complications = 3    

Average number of days between dressings changes (SD)
Group A: 2.1 (0.6)
Group B: 2.4 (0.3)

n/r

Comparison 5 Trial data, Outcome 1 Trial data.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
Figure 1

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 2

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

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Comparison 1 Fibrous‐hydrocolloid (hydrofibre) dressing compared with basic wound contact dressing, Outcome 1 Number of ulcers healed.
Figures and Tables -
Analysis 1.1

Comparison 1 Fibrous‐hydrocolloid (hydrofibre) dressing compared with basic wound contact dressing, Outcome 1 Number of ulcers healed.

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Comparison 2 Hydrocolloid (matrix) dressing compared with foam dressing, Outcome 1 Number of ulcers healed.
Figures and Tables -
Analysis 2.1

Comparison 2 Hydrocolloid (matrix) dressing compared with foam dressing, Outcome 1 Number of ulcers healed.

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Comparison 3 Silver hydrocolloid dressing compared with alginate dressing, Outcome 1 Number of ulcers healed.
Figures and Tables -
Analysis 3.1

Comparison 3 Silver hydrocolloid dressing compared with alginate dressing, Outcome 1 Number of ulcers healed.

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Comparison 4 Iodine‐impregnated dressing compared with fibrous‐hydrocolloid (hydrofibre) dressing, Outcome 1 Number of ulcers healed.
Figures and Tables -
Analysis 4.1

Comparison 4 Iodine‐impregnated dressing compared with fibrous‐hydrocolloid (hydrofibre) dressing, Outcome 1 Number of ulcers healed.

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Study

Groups

Primary outcome: ulcer healing

Secondary: health‐related quality of life

Number and level of amputations

Adverse events, including pain

Cost

Ulcer recurrence

Heading 8

Clever 1995

Group A (n = 20): Hydrocolloid (polyurethane matrix) dressing

Group B (n = 20): Foam dressing

Number of ulcers healed:
Group A: 16

Group B: 14
Mean time to healing in days (SD)
Group A: 25.19 (23.52)

Group B: 20.43 (14.74)
Median time to healing in days
Group A: 15.5 (range 4 to 76)

Group B: 16.5 (range 4 to 52)
Wound size at 4 weeks mm2 (SD):
Group A: 32.37 (54.12)

Group B: 33.46 (75.22)

n/r

n/r

(Reasons not reported separately for 2 groups):
Group A: 1

Group B: 5

Mean number of dressing changes between clinical visits (SD):
Group A: 2.23 (2.19)

Group B: 2.37 (2.18)

n/r

Jeffcoate 2009

Group A (n = 103): Fibrous‐hydrocolloid

(hydrofibre) dressing

Group B (n = 108): Iodine‐impregnated dressing
Group C (n = 106): non‐adherent dressing, viscose filament gauze

Number of ulcers healed at 24 weeks:
Group A: 46

Group B: 48
Group C: 41
Mean time to healing in days (SD) (fixed at max of 168 days)
Group A: 125.8 (55.9)

Group B: 127.8 (54.2)
Group C  130.7 (52.4)

Mean Cardiff Wound Impact Schedule score at 24 weeks (SD)

Group A: Physical functioning: 71.4 (19.5).  Social functioning: 70.3 (25.4). Well being: 53.1 (19.9)
Group B: Physical functioning: 67.1 (23.6).  Social functioning: 69.7 (24.1). Well being: 51.0 (22.3) 
Group C: Physical functioning: 68.9 (19.1).  Social functioning: 69.8 (23.5). Well being: 50.2 (21.1) 
Other
Study also reports mean and SD for each of the eight domains of the SF‐36. No significant different between the groups for any domain.

Minor amputations (Below ankle):
Group A: 3
Group B: 1
Group C: 1
Major amputations (Above knee)
Group A: 1
Group B: 0
Group C: 1

Non‐serious adverse events
Group A: 227

Group B: 239
Group C: 244
Serious adverse events
Group A: 28

Group B: 37
Group C: 35

Cost in GBP per patient for dressing management:
Mean (95% CI)

Group A: 191.33 (148.41 to 234.25)
Group B: 183.60 (128.92 to 238.21)
Group C: 141.18 (108.18 to 174.17)
Cost in GBP of professional time in managing foot ulcers: Mean (95% CI)

Group A: 459.87 (354.78 to 564.97)
Group B: 556.90 (422.32 to 691.48)
Group C: 448.86 (348.68 to 549.03
Cost in GBP of generating a healed ulcer using non‐adherent dressing (Group C): 362.

Cost in GBP of generating an additional healed ulcer:

Group A: 836

Group B: 848

At same site
Group A: 3
Group B: 7
Group C: 3

Jude 2007

Group A (n = 67): Fibrous‐hydrocolloid (hydrofibre) dressing with 1.2% ionic silver  
Group B (n = 67): Calcium‐alginate dressing

Number of ulcers healed in 8 weeks
Group A: 21
Group B: 15
Velocity of healing cm2/week (SD):
Group A: 0.29 (0.33) (n = 61)
Group B: 0.26 (0.90) (n = 61)
Velocity of healing as % per week (SD):
Group A: 11.6 (17.7) (n = 61)   
Group B: 10.0 (15.5)  (n = 61)                 
Mean time in days to healing (SD):
Group A: 52.6 (1.8)       
Group B: 57.7 (1.7)                                                                
Reduction in ulcer area in 8 weeks:
Group A: 58.1 (53.1).
Group B: 60.5 (42.7). 
Reduction in ulcer depth (cm) at 8 weeks (SD):
Group A:  0.25 (0.49)   
Group B:  0.13 (0.37)   


                              

n/r

n/r

Group A: 25 participants experienced one or more events. Death = 1; Infection = 14. 8 participants discontinued treatment due to AE.                                            
Group B: 26 participants experienced adverse event. Death = 1; Infection = 8. 13 participants discontinued treatment due to AE.                 

Mean number of dressing changes during study:
Group A: 21.9    
Group B: 20.8   

n/r

Kuo 2012

Group A (n = 12): fibrous‐hydrocolloid (hydrofibre) dressing
Group B (n = 12): cream contained extracts from two botanical raw materials, P. amboinicus and C. asiatica.

Percent change in wound size (from baseline ‐ assumed to 14 days).

Median and (IQR)

Group A: ‐22.64 (‐36.90 to ‐3.20)

Group B: ‐ 27.18(‐38.86 to 36.10)

Reported in paper as not statistically significant from Mann‐Whitney U test. P = 0.673

n/r

n/r

Number of people with one or more adverse events

Group A: 5/12 (41.7%)

Group B: 5/12 (41.7%)

Piaggesi 2001

Group A (n = 10): Fibrous‐hydrocolloid

(hydrofibre) dressing
Group B (n = 10): Saline‐moistened gauze dressing

Number of ulcers healed (during period of study):
Group A: 9
Group B: 10
Healing time in days (mean) (SD)
Group A: 127 (46 days)
Group B: 234 (61 days) 
Median % reduction in lesion volume at 8 weeks follow up (interquartile range):
Group A: 50 (26)           
Group B: 35 (15) 
Median % of granulation tissue at 8 weeks follow up (interquartile range)
Group A: 60 (40)               
Group B: 32.5 (10)                       

    

n/r

Group A: Amputation of a lesser toe = 3; Amputation of 2 lesser toes = 1; Metatarsal resection = 1
Group B: Amputation of a lesser toe = 2; Metatarsal resection = 1

Group A: Maceration of peri‐lesional skin = 1; Infective complications = 1
Group B: Maceration of peri‐lesional skin = 2; Infective complications = 3    

Average number of days between dressings changes (SD)
Group A: 2.1 (0.6)
Group B: 2.4 (0.3)

n/r

Figures and Tables -
Analysis 5.1

Comparison 5 Trial data, Outcome 1 Trial data.

Navigate to figure in Review
Summary of findings for the main comparison. Fibrous‐hydrocolloid (hydrofibre) dressing compared to basic wound contact dressing for healing diabetic foot ulcers

Fibrous‐hydrocolloid (hydrofibre) dressing compared to basic wound contact dressing for healing diabetic foot ulcers

Patient or population: patients with healing diabetic foot ulcers
Settings: Any
Intervention: Fibrous‐hydrocolloid (hydrofibre) dressing
Comparison: basic wound contact dressing

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Basic wound contact dressing

Fibrous‐hydrocolloid (hydrofibre) dressing

Number of ulcers healed

Low1

RR 1.01
(0.74 to 1.38)

229
(2 studies)

⊕⊕⊕⊝
moderate2

340 per 1000

343 per 1000
(252 to 469)

Moderate1

530 per 1000

535 per 1000
(392 to 731)

High1

650 per 1000

657 per 1000
(481 to 897)

HRQoL

See comment

See comment

Not estimable

0
(0)

See comment

One study measured HRQoL at 24 weeks follow‐up. Data from several domains are presented in the report, with no statistically significant difference observed.

Adverse events

See comment

See comment

Not estimable

0
(0)

See comment

AEs for two studies ‐ very similar numbers in each arms. Data not analysed here as not independent ‐ that is one person could have multiple events or due to limited data.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Baseline risk of healing obtained from external source in which data from 27,630 patients with a diabetic neuropathic foot ulcer was used to develop a simple prognostic model to predict likelihood of ulcer healing (Margolis DJ, Allen‐Taylor L, Hoffstad O, Berlin JA. Diabetic neuropathic foot ulcers: predicting which ones will not heal. Am J Med. 2003;115:627‐31). It is important to note that given an outcome of ulcer healing, low risk refers to a low risk of healing and thus reflects the most severe patient populations. Conversely high risk refers to a high risk of healing.
2 108 participants achieved the endpoint of healing in the two studies, this is an underpowered comparison. The confidence interval around the estimate of relative risk is consistent with a 26% relative reduction in healing with hydrocolloid and a 38% relative increase in healing with hydrocolloid.

Figures and Tables -
Summary of findings for the main comparison. Fibrous‐hydrocolloid (hydrofibre) dressing compared to basic wound contact dressing for healing diabetic foot ulcers
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Table 1. Summary of studies

First author

Group A

Group B

Group C

Duration of follow up

% healed data

Clever 1995

Hydrocolloid (polyurethane matrix) dressing (Cutinova Hydro, S&N Hlth)

Foam dressing (Allevyn, S&N Hlth)

16 weeks

yes

Jeffcoate 2009

Fibrous‐hydrocolloid (hydrofibre) dressing (Aquacel, ConvaTec)

Iodine‐impregnated dressing (Inadine, Johnson & Johnson)

Non‐adherent dressing (Johnson & Johnson)

24 weeks

yes

Jude 2007

Fibrous‐hydrocolloid (hydrofibre) dressing with 1.2% ionic silver (Aquacel Ag, ConvaTec)

Calcium‐alginate dressing (Algosteril, S&N Hlth)

8 weeks

yes

Kuo 2012

Fibrous‐hydrocolloid (hydrofibre) dressing (Aquacel, ConvaTec)

Cream contained extracts from two botanical raw materials, P. amboinicus and C. asiatica.(Active ingredient 1.25%)

2 weeks

No

Piaggesi 2001

Fibrous‐hydrocolloid (Hydrofibre) dressing (Aquacel, ConvaTec)

Saline‐moistened gauze

Not reported (maximum follow up was 350 days)

yes
Figures and Tables -
Table 1. Summary of studies
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Comparison 1. Fibrous‐hydrocolloid (hydrofibre) dressing compared with basic wound contact dressing

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of ulcers healed Show forest plot

2

229

Risk Ratio (M‐H, Random, 95% CI)

1.01 [0.74, 1.38]
Figures and Tables -
Comparison 1. Fibrous‐hydrocolloid (hydrofibre) dressing compared with basic wound contact dressing
Navigate to table in Review
Comparison 2. Hydrocolloid (matrix) dressing compared with foam dressing

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of ulcers healed Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only
Figures and Tables -
Comparison 2. Hydrocolloid (matrix) dressing compared with foam dressing
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Comparison 3. Silver hydrocolloid dressing compared with alginate dressing

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of ulcers healed Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only
Figures and Tables -
Comparison 3. Silver hydrocolloid dressing compared with alginate dressing
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Comparison 4. Iodine‐impregnated dressing compared with fibrous‐hydrocolloid (hydrofibre) dressing

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of ulcers healed Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only
Figures and Tables -
Comparison 4. Iodine‐impregnated dressing compared with fibrous‐hydrocolloid (hydrofibre) dressing
Navigate to table in Review
Comparison 5. Trial data

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Trial data Show forest plot

Other data

No numeric data
Figures and Tables -
Comparison 5. Trial data
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