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Tratamiento de heridas a presión negativa para el tratamiento de las heridas del pie en pacientes con diabetes mellitus

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References

References to studies included in this review

Armstrong 2005 {published data only}

Apelqvist J, Armstrong DG, Lavery LA, Boulton AJ. Resource utilization and economic costs of care based on a randomized trial of vacuum‐assisted closure therapy in the treatment of diabetic foot wounds. American Journal of Surgery  2008;195(6):782‐8.
Apelqvist J, Armstrong DG, Lavery LA, Boulton AJM. Diabetic foot ulcer and VAC resource utilization and economic cost based on a randomized trial. 20th Annual Symposium on Advanced Wounds Care and the Wound Healing Society Meeting; 2007, 28 April ‐1 May. Tampa, FL, 2007.
Armstrong DG, Lavery LA. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet 2005;366(9498):1704‐10.
Armstrong DG, Lavery LA, Boulton AJ. Negative pressure wound therapy via vacuum‐assisted closure following partial foot amputation: What is the role of wound chronicity?. International Wound Journal  2007;4(1):79‐86.
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. Paris, 2004.
Driver V, Andersen C, Taneja C, Oster G. Evaluation of health‐care utilization and costs for hospitalizations and surgical procedures in patients with diabetic foot ulcers treated with negative pressure wound therapy using open cell foam versus advanced moist wound therapy. 3rd Congress of the World Union of Wound Healing Societies Meeting; 2008, 4‐8 June; Toronto. Toronto, 2008:Abstract no. OR035.

Blume 2008 {published data only}

Blume PA, Sumpio BE. Interim results of a randomized, controlled multicenter trial of vacuum‐assisted closure therapy* in the treatment and blinded evaluation of diabetic foot ulcers. 20th Annual Symposium on Advanced Wounds Care and the Wound Healing Society Meeting; 2007, 28 April ‐1 May. Tampa, FL, 2007.
Blume PA, Walters J, Payne W, Ayala J, Lantis J. Comparison of negative pressure wound therapy using Vacuum‐assisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: a multicenter randomized controlled trial. Diabetes Care  2008;31(4):631‐6.

Karatepe 2011 {published data only}

Karatepe O, Eken I, Acet E, Unal O, Mert M, Koc B, et al. Vacuum assisted closure improves the quality of life in patients with diabetic foot. Acta Chirurgica Belgica 2011;111(5):298‐302.

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.

Novinščak 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 [Usporedba troska i koristi (cost‐benefit)triju nacina lijecenja dijabetickog vrijeda: Suhim prevojem, vlaznim prevojem i negativnim tlakom LA: Cro]. Acta Medica Croatica 2010;64(Suppl 1):113‐5.

References to studies excluded from this review

Armstrong 2012 {published data only}

Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparative effectiveness of mechanically and electrically powered negative pressure wound therapy devices: a multicenter randomized controlled trial. Wound Repair and Regeneration 2012;20(3):332‐41.
Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: a multicenter randomized‐controlled trial. Wound Repair and Regeneration  2011;19(2):173‐80.
Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. NPWT comparative effectiveness trial. Wound Repair and Regeneration  2012;20(3):332‐41.

Braakenburg 2005 {published data only}

Braakenburg A, Obdeijn MC, Feitz R, van Rooij IA, van Griethuysen AJ, Klinkenbijl JH. The clinical efficacy and cost effectiveness of the vacuum‐assisted closure technique in the management of acute and chronic wounds: a randomized controlled trial. Plastic and Reconstructive Surgery  2006;118(2):390‐7.

Chong {published data only}

Chong SJ, Kwan TM, Weihao L, Joang KS, Rick SC. Maintenance of negative‐pressure wound therapy while undergoing hyperbaric oxygen therapy. Diving and hyperbaric medicine: the journal of the South Pacific Underwater Medicine Society  2011;41(3):147‐50.

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 2007 {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.

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. Paris, 2004.

Maggio 2010 {published data only}

Maggio G, Armenio A, Pascone M. Bio‐engineered tissue and VAC therapy: A new method for the treatment of the wide soft tissue defects in the diabetic foot. European Journal of Clinical Investigation 2010;40:87.

McCallon 2000 {published data only}

McCallon SK, Knight CA, Valiulus JP, Cunningham MW, McCulloch JM, 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.

Moues 2004 {published data only}

Moues CM, Vos MC, van den Bemd GJ, Stijnen T, Hovius SE. Bacterial load in relation to vacuum‐assisted closure wound therapy: a prospective randomized trial. Wound Repair and Regeneration 2004;12(1):11‐7.
Moues CM, van den Bemd GJ, Heule F, Hovius SE. Comparing conventional gauze therapy to vacuum‐assisted closure wound therapy: a prospective randomised trial. Journal of Plastic, Reconstructive and Aesthetic Surgery 2007;60(6):672‐81.
Mouës CM, van den Bemd GJ, Meerding WJ, Hovius SE. An economic evaluation of the use of TNP on full‐thickness wounds. Journal of Wound Care 2005;14(5):224‐7.

Perez 2010 {published data only}

Perez D, Bramkamp M, Exe C, von Ruden C, Ziegler A. Modern wound care for the poor: a randomized clinical trial comparing the vacuum system with conventional saline‐soaked gauze dressings. American Journal of Surgery  2010;199(1):14‐20.

Rahmanian‐Schwarz 2012 {published data only}

Rahmanian‐Schwarz A, Willkomm LM, Gonser P, Hirt B, Schaller HE. A novel option in negative pressure wound therapy (NPWT) for chronic and acute wound care. Burns 2012;38(4):573‐7.

Riaz 2010 {published data only}

Riaz MU, Khan M‐UR, Akbar A. Comparison of vacuum assisted closure versus normal saline dressing in healing diabetic wounds. Pakistan Journal of Medical and Health Sciences 2010;4(4):308‐12.

Sepulveda 2009 {published data only}

Sepulveda G, Espindola M, Maureira M, Sepulveda E, Fernandez JI, Oliva C, et al. Negative‐pressure wound therapy versus standard wound dressing in the treatment of diabetic foot amputation. A randomised controlled trial. Cirugia Espanola 2009;86(3):171‐7.

References to studies awaiting assessment

Sun 2007 {published data only}

Sun JW, Sun JH, Zhang CC. Vacuum assisted closure technique for repairing diabetic foot ulcers: Analysis of variance by using a randomized and double‐stage crossover design. Journal of Clinical Rehabilitative Tissue Engineering Research 2007;11(14):8908‐11.

Tuncel 2013 {published data only}

Tuncel U, Erkorkmaz U, Turan A. Clinical evaluation of gauze‐based negative pressure wound therapy in challenging wounds. International wound journal 2013;10:152‐158.

ISRCTN34166832 {published data only}

ISRCTN34166832. 100 Patient study of PICO v Standard care in chronic / sub‐acute wounds. http://www.controlled‐trials.com/ISRCTN34166832 (accessed 5 October 2013).

ISRCTN90301130 {published data only}

ISRCTN90301130. Treatment of Diabetic Foot Wounds by Vacuum‐Assisted Closure (VAC®): A multicentre, randomised controlled trial. http://www.controlled‐trials.com/ISRCTN90301130 (accessed 5 October 2013).

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(5):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 Reviews 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.

Centers for Disease Control and Prevention 2011

Centers for Disease Control and Prevention. 2011 National Diabetes Fact Sheet. http://www.cdc.gov/diabetes/pubs/estimates11.htm2011; Vol. Access Dec 2012.

Deeks 2002

Deeks JJ. Issues in the selection of a summary statistic for meta‐analysis of clinical trials with binary outcomes. Statistics in Medicine 2002;21(1):575‐600.

Department of Health 2010

Department of Health. About diabetes [Diabetes in the UK 2010:Key statistics on diabetes]. http://www.diabetes.org.uk/Documents/Reports/Diabetes_in_the_UK_2010.pdf2010; Vol. Access Jan 2013.

Department of Health and Human Services 2009

Department of Health and Human Services, Office of Inspector General. Comparison of prices for negative pressure wound therapy pumps. https://oig.hhs.gov/oei/reports/oei‐02‐07‐00660.pdf. OEI‐02‐07‐00660 2009; Vol. Access Dec 2012.

Diabetes UK 2011

Diabetes UK. Diabetes Prevalence 2011. http://www.diabetes.org.uk/Professionals/Publications‐reports‐and‐resources/Reports‐statistics‐and‐case‐studies/Reports/Diabetes‐prevalence‐2011‐Oct‐2011/2011; Vol. Access Dec 2012.

Dorresteijn 2010

Dorresteijn JAN, Kriegsman DMW, Valk GD. Complex interventions for preventing diabetic foot ulceration. Cochrane Database of Systematic Reviews 2010, Issue 1. [DOI: 10.1002/14651858.CD007610.pub2]

Dumville 2011a

Dumville JC, O'Meara S, Deshpande S, Speak K. Hydrogel dressings for healing diabetic foot ulcers. Cochrane Database of Systematic Reviews 2011, Issue 9. [DOI: 10.1002/14651858.CD009101.pub2]

Dumville 2011b

Dumville JC, Deshpande S, O'Meara S, Speak K. Foam dressings for healing diabetic foot ulcers. Cochrane Database of Systematic Reviews 2011, Issue 9. [DOI: 10.1002/14651858.CD009111.pub2]

Dumville 2012a

Dumville JC, Deshpande S, O'Meara S, Speak K. Hydrocolloid dressings for healing diabetic foot ulcers. Cochrane Database of Systematic Reviews 2012, Issue 2. [DOI: 10.1002/14651858.CD009099.pub2]

Dumville 2012b

Dumville JC, O'Meara S, Deshpande S, Speak K. Alginate dressings for healing diabetic foot ulcers. Cochrane Database of Systematic Reviews 2012, Issue 2. [DOI: 10.1002/14651858.CD009110.pub2]

Dumville 2012c

Dumville JC, Soares MO, O'Meara S, Cullum N. Systematic review and mixed treatment comparison: dressings to heal diabetic foot ulcers. Diabetologia 2012;55(7):1902‐10.

Eneroth 2008

Eneroth M, Van Houtum WH. The value of debridement and Vacuum‐Assisted Closure (V.A.C.) Therapy in diabetic foot ulcers. Diabetes Metabolism Research and Review 2008;24(Suppl 1):S76‐80.

FDA 2011

US Food, Drug Administration. FDA Safety Communication: Update on serious complications associated with negative pressure wound therapy systems. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm244211.htm2011; Vol. Access Nov 2012.

Game 2012

Game FL, Hinchliffe RJ, Apelqvist J, Armstrong DG, Bakker K, Hartemann A, et al. A systematic review of interventions to enhance the healing of chronic ulcers of the foot in diabetes. Diabetes Metabolism Research and Reveiw 2012;Suppl 1:119‐41.

Higgins 2003

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Higgins 2011

Higgins JPT, Altman DG, on behalf of the Cochrane Statistical Methods Group and the Cochrane Bias Methods Group (Editors). Chapter 8:  Assessing risk of bias in included studies. 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.

Holman 2012

Holman N, Young RJ, Jeffcoate WJ. Variation in the recorded incidence of amputation of the lower limb in England. Diabetologia 2012;55(7):1919‐25.

Ince 2008

Ince P, Abbas ZG, Lutale JK, Basit A, Ali SM, Chohan F, et al. Use of the SINBAD classification system and score in comparing outcome of foot ulcer management on three continents. Diabetes Care 2008;31(5):964‐7.

Karthikesalingam 2010

Karthikesalingam A, Holt PJE, Moxey P, Jones KG, Thompson MM, Hinchliffe RJ. A systematic review of scoring systems for diabetic foot ulcers. Diabetic Medicine 2010;27(5):544‐9.

KCI 2012a

KCI. Science behind wound therapy. http://www.kci1.com/KCI1/sciencebehindwoundtherapy (accessed 11th May 2012).

KCI 2012b

KCI. VAC therapy system clinical guidelines. http://www.kci1.com/KCI1/vactherapyformsandbrochures (acessed 11th May 2012).

Kerr 2012

Kerr M. Foot care for people with diabetes: the economic case for change. Factsheet No. 372012 March; Vol. http://www.diabetes.org.uk/upload/News/Factsheet%20Footcare%20for%20people%20with%20diabetes.pdf.

Kumar 1994

Kumar S, Ashe HA, Parnell LN, Fernando DJ, Tsigos C, Young RJ, et al. The prevalence of foot ulceration and its correlates in type 2 diabetic patients: a population‐based study. Diabetic Medicine 1994;11(5):480‐4.

Lebrun 2010

Lebrun E, Tomic‐Canic M, Kirsner RS. The role of surgical debridement in healing of diabetic foot ulcers. Wound Repair and Regeneration 2010;18(5):433‐8.

Lefebvre 2011

Lefebvre C, Manheimer E, Glanville J, on behalf of the Cochrane Information Retrieval Methods Group. Chapter 6: Searching for studies. 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.

Liberati 2009

Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta‐analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Medicine 2009;6(7):e1000100.

Margolis 1999

Margolis D, Kantor J, Berlin J. Healing of diabetic neuropathic foot ulcers receiving standard treatment. A meta‐analysis. Diabetes Care 1999;22(5):692‐5.

Margolis 2011

Margolis D, Malay DS, Hoffstad OJ, Leonard CE, MaCurdy T, Lopez de Nava K, et al. Prevalence of diabetes, diabetic foot ulcer, and lower extremity amputation among Medicare beneficiaries, 2006 to 2008. Diabetic foot ulcers. Data Points #1 (prepared by the University of Pennsylvania DEcIDE Center, under Contract No. HHSA29020050041I). Agency for Healthcare Research and Quality. AHRQ Publication No. 10(11)‐EHC009‐EF.2011.

Medical Advisory Secretariat 2006

Medical Advisory Secretariat. Negative pressure wound therapy: an evidence‐based analysis. Negative pressure wound therapy ‐ Ontario Health Technology Assessment Series 20062006; Vol. 6, issue 14:1‐38.

Morris 1998

Morris AD, McAlpine R, Steinke D, Boyle DI, Ebrahim AR, Vasudev N, et al. Diabetes and lower limb amputations in the community. A retrospective cohort study. DARTS/MEMO Collaboration. Diabetes Audit and Research in Tayside Scotland/Medicines Monitoring Unit. Diabetes Care 1998;21(5):738‐43.

Nabuurs‐Franssen 2005

Nabuurs‐Franssen MH, Huijberts MS, Nieuwenhuijzen Kruseman AC, Willems J, Schaper NC. Health‐related quality of life of diabetic foot ulcer patients and their caregivers. Diabetologia 2005;48(9):1906‐10.

NICE 2011

National Institute for Health and Clinical Excellence. Diabetic foot problems ‐ inpatient management: pre‐publication check. http://www.nice.org.uk/guidance/index.jsp?action=folder&o=524182011.

Noble‐Bell 2008

Noble‐Bell G, Forbes A. A systematic review of the effectiveness of negative pressure wound therapy in the management of diabetes foot ulcers. International Wound Journal 2008;5(2):233‐42.

Oyibo 2001

Oyibo SO, Jude EB, Tarawneh I, Nguyen HC, Harkless LB, Boulton AJ. A comparison of two diabetic foot ulcer classification systems: the Wagner and the University of Texas wound classification systems. Diabetes Care 2001;24(1):84‐8.

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Pecoraro RE, Reiber GE, Burgess EM. Pathways to diabetic limb amputation: basis for prevention. Diabetes Care 1990;13(5):513‐21.

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Peinemann F, McGauran N, Sauerland S, Lange S. Negative pressure wound therapy: potential publication bias caused by lack of access to unpublished study results data. BMC Medical Research Methodology 2008;8:4.

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

Armstrong 2005

Methods

2‐arm RCT; undertaken in USA (in wound and academic centres)

Participants

162 adult participants

Inclusion criteria: presence of: (1) wound from a diabetic foot amputation to the transmetatarsal level of the foot; (2) adequate perfusion; (3) University of Texas grade 2 or 3

Exclusion criteria: people presenting with (1) active Charcot arthropathy of the foot; (2) wounds resulting from burns; (3) venous insufficiency; (4) untreated cellulitis or osteomyelitis (after amputation); (5) collagen vascular disease; (6) malignant disease in the wound; or people treated with: (7) corticosteroids;  (8) immunosuppressive drugs or chemotherapy; (9) NPWT (in the last 30 days); (10) growth factors; (11) normothermic therapy; (12) hyperbaric medicine; (13) bioengineered tissue products (in the last 30 days)

Key baselines co‐variates:

Wound area (cm2):

Group A: 19.2 (SD = 17.6)

Group B: 22.3 (SD = 23.4)

 

Wound duration (months):

Group A: 1.8 (SD = 5.9)

Group B: 1.2 (SD = 3.9)

75.3% of the study population had wounds that were < 30 days' duration (classed as acute wounds by the author) and 24.7% had wounds that were > 30 days' duration (classed as chronic wounds by authors)

Interventions

Group A (n = 85): moist wound therapy with alginates, hydrocolloid, foam or hydrogel dressings – adhering to standardised guidelines at the discretion of attending clinician. Dressings changed every other day unless recommended by treating clinician

Group B (n = 77): NPWT (VAC® system) no information provided regarding the pressure applied or the cycle (e.g. constant/cyclical etc); dressing changes every 48 h. Treatment conducted until wound closure or completion of 112 day assessment.

 

All participants received: (1) off‐loading therapy, preventatively and therapeutically as indicated ‐ a pressure relief sandal or walker was provided for all participants; (2) sharp debridement within 2 days of randomisation and as deemed necessary by treating clinician; and, (3) measurement of pre‐albumin, albumin and HbA1c levels in 7 days before entering the study. Low pre‐study albumin levels resulted in consultation with nutritionist, and dietary supplement initiated if needed. 

Outcomes

Primary outcome: (1) number of wounds completely healed (defined as 100% re‐epithelialisation without drainage and INCLUDED closure via surgery where the decision for surgical closure was made by treating clinician); (2) time to wound healing; (3) amputation

Secondary outcomes: (1) other adverse events (serious and non‐serious); (2) resource use

Notes

Follow‐up: 112 days (16 weeks)

Outcome assessment: based on data from wound assessments and digital photographs taken by treatment clinicians at days 0, 7, 14, 28, 42, 56, 84 and 112

A secondary analysis of trial data reported that 75% of wounds were ≤ 1 month in duration (classed by authors as acute) and 25% were > 1 month in duration (classed by authors as chronic). We note that mean baseline values for ulcer duration were obviously very skewed

Funding: study funded by KCI – manufacturers of the VAC® intervention

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomisation was accomplished by using www.randomizer.org to generate 15 blocks of 10  random numbers each."

Comment: adequate methodology

Allocation concealment (selection bias)

Low risk

Quote: "Numbers were systematically assigned to each treatment group, and sealed envelopes containing opaque, black paper labelled with assigned treatment and patient ID number were sequentially numbered and provided to each site. The black paper was added to ensure that the contents of the envelopes were not visible prior to opening."

Comment: adequate methodology

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: it is understandably not possible to blind participants and patients to whether or not they receive NPWT. However, given this, it is important that any decision‐making that might be affected by performance bias is recognised and blinding is introduced where possible.  We note that unblinded health professionals were able to make decisions about closure surgery that could then have resulted in more wounds being closed (and classed as healed) or amputated in one group compared to the other. As a result of this we classed the risk of bias for this domain as unclear.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Quote: "Neither patients nor investigators were masked to the randomised treatment assignment . . . However, notes that the masking component of the study dealt specifically with planimetry measurements from digital photographs . . . concordance between the investigator and the digital planimetry provided independent confirmation of the primary efficacy endpoint of complete wound healing."

Comment: assessment of healing seems to have had a blinded component

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: no evidence of incomplete outcome data

Other bias

Low risk

No evidence of other bias

Blume 2008

Methods

2‐arm RCT; undertaken in USA

Participants

342 adult participants

Inclusion criteria: (1) stage 2 or 3 (Wagner’s scale) calcaneal, dorsal or planter foot ulcer; ulcer ≥ 2 cm2 in area after debridement; (3) adequate blood perfusion (various tests and cut‐offs reported)

Exclusion criteria: (1) recognised active Charcot disease; (2) ulcers resulting from electrical, chemical or radiation burns; (3) collagen vascular disease; (4) ulcer malignancy; (5) untreated osteomyelitis or cellulitis; (6) uncontrolled hyperglycaemia; (7) inadequate lower extremity perfusion; (8) pregnant or nursing mothers; or ulcer treatment within 30 days of trial start with (9) normothermic or hyperbaric oxygen therapy, (10) corticosteroids, (11) immunosuppressive drugs, (12) chemotherapy, (13) recombinant or autologous growth factor products, (14) skin and dermal substitutes; or (15) use of any enzymic debridement treatment.

Key baselines co‐variates:

Wound area (cm2):

Group A: 11.0 (SD = 12.7)

Group B: 13.5 (SD = 18.2)

 

Wound duration (months)

Group A: 6.9  (SD = 12.2)

Group B: 6.6 (SD = 10.8)

Interventions

Group A (n = 169): advanced moist wound therapy dressings used according to guidelines/local protocols ‐ noted as being predominantly hydrogels and alginates

Group B (n = 172): NPWT (VAC® system) applied according to manufacturer’s instructions, but no information provided about the pressure applied or the cycle (e.g. constant/cyclical etc).  Treatment continued until wound closure, or until there was sufficient granulation tissue formation for healing by primary and secondary intention

All participants received: (1) assessment and debridement of ulcers within 2 days of randomisation; (2) off‐loading therapy as deemed necessary

Outcomes

Primary outcome: (1) number of wounds completely healed (defined as 100% re‐epithelialisation without drainage or dressing requirement and INCLUDED closure via surgery where the decision for surgical closure was made by treating clinician); (2) time to wound healing; (3) amputation

Secondary outcomes: (1) other adverse events (serious and non‐serious); (2) resource use

Notes

Follow‐up: 112 days (16 weeks)

Outcome assessment: participants examined weekly for the first 4 weeks and then every other day until day 112, or ulcer closure by any means. Participants achieving closure were followed up at 3 and 9 months

Funding: study funded by KCI – manufacturers of the VAC® intervention

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote:"Randomization was accomplished by generating blocks of numbers through http://www.randomizer.org."

Comment: adequate methodology

Allocation concealment (selection bias)

Low risk

Quote: "Numbers were assigned to a treatment group and sealed in opaque envelopes containing black paper labelled with treatment and patient ID. Envelopes were sequentially numbered before clinical trial site distribution. At patient randomisation, treatment was assigned on the basis of the next sequentially labelled envelope."

Comment: adequate methodology

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Comment: It is understandably not possible to blind participants and patients to whether or not they receive NPWT. However, given this, it is important that any decision‐making that might be affected by performance bias is recognised and blinding is introduced where possible.  We note that unblinded health professionals were able to make decisions about undertaking closure surgery that could then have resulted more wounds being closed (and classed as healed) or amputated in one group compared with the other. As a result of this we classed the risk of bias for this domain as unclear

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Quote: "Blinded photographic evaluation was conducted."

Comment. whilst the main report has no discussion of blinded outcome assessment, it is mentioned in the conference abstract describing the study. However as with Armstrong 2005 we note that unblinded health professionals in 1 group were able to make decisions about undertaking closure surgery that could then have resulted more wounds being closed (and classed as healed) or amputated. As a result of this we classed the risk of bias for this domain as unclear

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Comment: 3 participants were excluded from analysis in each arm as they did not receive the trial treatment allocated. There were relatively low numbers of exclusions, although ideally data on these participants would have been included in the RCT report. Additionally, 31% of participants in the NPWT group and 25% in the dressing group were classed as being 'discontinued' for reasons that included adverse events, ineffective treatment and also death. It is not clear whether participants who were discontinued for reasons other than death were also censored from the analysis, rather than being followed up. If discontinuation did result in censoring in this open trial it may have introduced bias

Other bias

Low risk

No evidence of other bias

Karatepe 2011

Methods

2‐arm RCT; undertaken in Turkey

Participants

67 adult participants.

Inclusion criteria: diabetic foot ulcers

Exclusion criteria: not reported

Key baselines co‐variates:

Wound area (cm2):

Group A: 29.7 (SD 5.2)

Group B: 35.7 (SD 6.4)

 

Wound duration (weeks):

Group A: 8.8 (SD 7.2)

Group B: 11.3 (9.2)

Interventions

Group A (n = 37): conventional wound care treatment (described as daily wound care, debridement and treatment of gangrenous tissue where required and use of sterilized gauze dressing).

Group B (n = 30): NPWT  (VAC® system)

Clinical measures included standard diabetic treatment, daily wound care including antiseptic bath, debridement, toe removal for gangrene when necessary, and wound care with conventional methods or VAC®. 

Outcomes

Primary outcome: time‐to‐healing

Secondary outcomes: health‐related quality of life measured with  SF‐36 (not clearly reported)

Notes

Follow‐up: final SF‐36 form completed 1 month after wound healing (mean in 4th month of study)

Outcome assessment: healing time calculated as the time from hospital admission to re‐epithelization

Funding: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Randomisation of the patients was arranged by the free use web based system (http://www.tufts.edu\˜gdall/PLAN.HTM)"

Comment: classed as an adequate method

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not reported

Other bias

Low risk

No evidence of other risk of bias

Mody 2008

Methods

2‐arm RCT; undertaken in India

Participants

48 participants (recruited from inpatient wards), 15 of whom were reported to have DM and a foot ulcer. Data for these 15 participants only are presented

Inclusion criteria: people admitted to general surgery, physical medicine, and rehabilitation wards and referred by the surgical consultants for care of an acute or chronic extremity, sacral, or abdominal wound that could not be treated with primary closure

Exlusion criteria: (1) ischaemic wounds; or wounds: (2) in anatomical locations where an adequate seal around the wound site could not be obtained; (3) with exposed bowel or blood vessels; (4) with necrotic tissue that could not be debrided; (5) with communicating fistulae; (6) with malignancy; (7) with recent grafts; or (8) presence of osteomyelitis; or (9) patient receiving therapeutic anticoagulation

Key baselines co‐variates (foot ulcers in people with diabetes only):

Wound area (cm2):

Group A: 48.1 (SD = 53.5)

Group B: 25.7 (SD = 9.7)

 

Wound duration (days):

Group A: 5.2 (SD = 2.3)

Group B: 8.5 (SD = 8.3)

Interventions

Group A (n = 9): saline‐soaked gauze and dry pads used to cover the wound. Dressing changes typically performed twice daily; frequency adjusted according to the judgment of the treating physician

Group B (n = 6): locally‐constructed (homemade) device: a sterilized, porous packing material obtained from a local source was cut to fit the wound. A 14‐French suction catheter was tunnelled into the packing material, which then was placed into the wound cavity. A sterile adhesive plastic drape (Dermincise, Vygon, UK) was cut to overlap the surrounding skin and applied over the packing material, forming an airtight seal. Tubing was used to attach the free end of the suction catheter to a wall suction canister. The TNP timer was placed in circuit between the wall suction apparatus and the wall suction canister

The TNP timer, constructed from local electronics, was designed to cycle wall suction intermittently using a simple timed switch and a system of valves. For the study protocol, the timer was set to cycle for 2 minutes on, followed by 5 minutes off. Wall suction pressure was set at 125 mmHg. In sensitive wounds, suction was reduced to a tolerable level (usually 50 mmHg to 100 mmHg) until it could be comfortably increased. For oedematous wounds, the suction was kept on a continuous setting until oedema had been reduced and an intermittent regimen could be followed. The dressing was changed every 2 days unless otherwise scheduled by the treating physician. Wounds were debrided as required to keep the wound bed free of necrotic tissue. Patients receiving NPWT who no longer required hospitalisations for their primary diagnosis, or could not afford to remain in the hospital, remained in the study with conventional wound dressings in the outpatient setting, but outcomes were analysed in the original treatment groups

Wounds in both treatment groups were debrided before dressing application

Outcomes

Primary outcome: number of days to satisfactory healing, defined as complete wound closure by secondary intention or wound readiness for delayed primary closure as determined by the study investigator and treating surgeon

Secondary outcomes: none reported separately for foot ulcers

Notes

Participants were followed until wound closure or being lost to follow‐up for an average of 26.3 days (+/‐ 18.5) in the control and 33.1 days (+/‐ 37.3) in the treatment group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Wounds that met inclusion and exclusion criteria were assessed for size (in a manner that allowed blinding) and then block‐randomized using a concealed computer‐generated table in a 1‐to‐2 ratio of TNP closure versus conventional wound dressing."

Comment: adequate method

Allocation concealment (selection bias)

Unclear risk

Quote: "Following enrolment, wound size was assessed using computer‐aided measurements of digital photographs and block‐randomized to the study arms using a concealed allocation table."

Comment: unclear how allocation concealment was conducted

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Seems that participants were analysed in groups as randomised

Other bias

Unclear risk

No evidence of other risk of bias

Novinščak 2010

Methods

3‐arm RCT; undertaken in Croatia

Participants

27 adult participants

Inclusion criteria: complicated diabetic ulcer (sic) managed to international guidelines for treatment protocol (confirmed with the author that these were all foot wounds)
Exclusion criteria: revascularization, reconstruction and amputation procedures were not considered in this study

Key baselines co‐variates: not reported

Wound duration (months): not reported

Interventions

Group A (n = 8): classic gauze

Group B (n = 12): moist dressings
Group C (n = 7): NPWT

Surgical debridement, off‐loading, co‐morbidity treatment and appropriate wound care were performed

Outcomes

Primary outcome: healing rate (author defined as wound closure – personal contact)

Notes

Follow‐up: 2 months, extracted from abstract only

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not reported

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not reported

Other bias

Unclear risk

No evidence of other risk of bias

Abbreviations

< = less than
> = more than
≤ = less than or equal to
≥ = more than or equal to
h = hour(s)
NPWT = negative pressure wound therapy
RCT = randomised controlled trial
SD = standard deviation
TNP = topical negative pressure (synonym for NPWT)

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Armstrong 2012

Included multiple wounds types. Unable to obtain diabetic foot wound data separately

Braakenburg 2005

Included multiple wounds types. Unable to obtain diabetic foot wound data separately

Chong

No relevant outcome reported

Eginton 2003

No relevant outcome reported

Etoz 2007

Not an RCT, as participants allocated using alternation

Foo 2004

No relevant outcome reported

Maggio 2010

Treatment with NPWT was not the only systematic difference between groups (intervention group receiving NPWT also received autologous fibroblasts and skin grafting)

McCallon 2000

Not an RCT, as participants allocated using alternation. Coin flipped for first participant and then participants allocated by alternation

Moues 2004

Not a diabetic foot wound study population

Perez 2010

Included multiple wounds types. Unable to obtain diabetic foot wound data separately

Rahmanian‐Schwarz 2012

Included multiple wounds types. Unable to obtain diabetic foot wound data separately

Riaz 2010

Included wounds in people with diabetes in regions other than the foot (legs and back). Unable to obtain diabetic foot wound data separately

Sepulveda 2009

No relevant outcome reported

Abbreviations

NPWT = negative pressure wound therapy
RCT = randomised controlled trial

Characteristics of studies awaiting assessment [ordered by study ID]

Sun 2007

Methods

Not clear: could be an RCT

Participants

People with DM and foot ulcers n = 38

Interventions

NPWT

Outcomes

Not clear ‐ seems to be wound dimensions

Notes

Requires translation from Chinese

Tuncel 2013

Methods

RCT

Participants

Mixed ‐ request data for foot wound participants and further details

Interventions

NPWT

Outcomes

Requested wound healing data from authors

Notes

Abbreviations

DM = diabetes mellitus
NPWT = negative pressure wound therapy
RCT = randomised controlled trial

Characteristics of ongoing studies [ordered by study ID]

ISRCTN34166832

Trial name or title

RCT PICO pilot study (Smith and Nephew)

Methods

RCT

Participants

Chronic and sub‐acute wounds (some potentially foot wounds in people with DM). Planned sample size of 100

Interventions

NPWT vs standard care

Outcomes

Time to wound closure

Starting date

Contact information

Emma.Whatley@smith‐nephew.com

Notes

ISRCTN record states end date of Aug 2012. Project Manager e‐mail: "I can confirm that recruitment for the study has not yet finished and that we currently have no DFU’s in the study. We expect that this might change with the possible addition of a new site. We are hoping to have some data by the middle of next year."

ISRCTN90301130

Trial name or title

Treatment of diabetic foot wounds by Vacuum‐Assisted Closure (VAC®): A multi‐centre randomised controlled trial (KCI)

Methods

RCT

Participants

Chronic or post‐amputation wounds on the feet of people with diabetes

Interventions

NPWT vs conventional moist wound therapy

Outcomes

Time to complete healing, percentage of wounds closed, recurrence, resource use, adverse events

Starting date

June 2011

Contact information

Ms D Seidel: doerthe.seidel@uni‐wh.de

Notes

End date cited as Sept 2013

Abbreviations
DM = diabetes mellitus
DFU = diabetic foot ulcer
NPWT = negative pressure wound therapy
RCT = randomised controlled trial

Data and analyses

Open in table viewer
Comparison 1. NPWT compared with moist (non‐gauze) wound dressings

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of wounds healed Show forest plot

2

503

Risk Ratio (M‐H, Fixed, 95% CI)

1.47 [1.18, 1.84]

Analysis 1.1

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 1 Proportion of wounds healed.

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 1 Proportion of wounds healed.

2 Time to healing Show forest plot

2

Hazard Ratio (Fixed, 95% CI)

1.85 [1.40, 2.45]

Analysis 1.2

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 2 Time to healing.

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 2 Time to healing.

3 Amputations Show forest plot

2

503

Risk Ratio (M‐H, Fixed, 95% CI)

0.35 [0.17, 0.74]

Analysis 1.3

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 3 Amputations.

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 3 Amputations.

4 Adverse events Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 1.4

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 4 Adverse events.

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 4 Adverse events.

4.1 All adverse events

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 Treatment‐related adverse events

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Open in table viewer
Comparison 2. NPWT compared with gauze dressings

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of wounds healed Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 2.1

Comparison 2 NPWT compared with gauze dressings, Outcome 1 Proportion of wounds healed.

Comparison 2 NPWT compared with gauze dressings, Outcome 1 Proportion of wounds healed.

Study flow diagram (Liberati 2009)
Figures and Tables -
Figure 1

Study flow diagram (Liberati 2009)

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
Figure 2

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

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 3

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

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 1 Proportion of wounds healed.
Figures and Tables -
Analysis 1.1

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 1 Proportion of wounds healed.

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 2 Time to healing.
Figures and Tables -
Analysis 1.2

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 2 Time to healing.

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 3 Amputations.
Figures and Tables -
Analysis 1.3

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 3 Amputations.

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 4 Adverse events.
Figures and Tables -
Analysis 1.4

Comparison 1 NPWT compared with moist (non‐gauze) wound dressings, Outcome 4 Adverse events.

Comparison 2 NPWT compared with gauze dressings, Outcome 1 Proportion of wounds healed.
Figures and Tables -
Analysis 2.1

Comparison 2 NPWT compared with gauze dressings, Outcome 1 Proportion of wounds healed.

Summary of findings for the main comparison. NPWT compared to Moist dressings for healing post‐operative wounds in people with diabetes

NPWT compared to Moist dressings for healing post‐operative wounds in people with diabetes

Patient or population: patients with healing post‐operative wounds in people with diabetes
Settings:
Intervention: NPWT
Comparison: Moist dressings

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Moist dressings

NPWT

Proportion of wounds healed
Follow‐up: mean 16 weeks

Study population

RR 1.44
(1.03 to 2.01)

162
(1 study)

⊕⊕⊝⊝
low1,2

388 per 1000

559 per 1000
(400 to 780)

Moderate

Time to ulcer healing
Follow‐up: mean 16 weeks

Study population

HR 1.91
(1.21 to 2.99)

162
(1 study)

⊕⊕⊝⊝
low1,3

388 per 1000

609 per 1000
(448 to 770)

Moderate

Amputation
Follow‐up: mean 16 weeks

Study population

RR 0.25
(0.05 to 1.10)

162
(1 study)

⊕⊝⊝⊝
very low1,4

106 per 1000

26 per 1000
(5 to 116)

Moderate

*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; HR: Hazard 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 There was the potential for performance bias as unblinded health professionals were able to make decisions about undertaking closure surgery that could then have resulted more wounds being closed (and classed as healed) or amputated in one group compared with the other.
2 The confidence interval around the estimate of relative risk is consistent with a 3% relative increase in healing with NPWT to a 101% relative increase in healing with NPWT.
3 The confidence interval around the estimate hazard ratio is consistent with a 21% relative increase in the hazard of healing with NPWT to a 199% relative increase in the hazard of healing with NPWT.
4 The confidence interval around the estimate of relative risk is consistent with a 95% relative reduction in chance of healing with NPWT to a 10% relative increase in healing with NPWT.

Figures and Tables -
Summary of findings for the main comparison. NPWT compared to Moist dressings for healing post‐operative wounds in people with diabetes
Summary of findings 2. NPWT compared to Moist dressings for debrided foot ulcers in people with diabetes

NPWT compared to Moist dressings for debrided foot ulcers in people with diabetes

Patient or population: patients with debrided foot ulcers in people with diabetes
Settings:
Intervention: NPWT
Comparison: Moist dressings

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Moist dressings

NPWT

Proportion of wounds healed
Follow‐up: mean 16 weeks

Low risk of healing1

RR 1.49
(1.11 to 2.01)

341
(1 study)

⊕⊕⊝⊝
low2,3

340 per 1000

507 per 1000
(377 to 683)

Moderate risk of healing1

530 per 1000

790 per 1000
(588 to 1000)

High risk of healing1

650 per 1000

968 per 1000
(722 to 1000)

Time to healing
Follow‐up: mean 16 weeks

Low risk of healing4

HR 1.82
(1.27 to 2.60)

341
(1 study)

⊕⊕⊝⊝
low2,5

340 per 1000

531 per 1000
(410 to 661)

Moderate risk of healing4

530 per 1000

747 per 1000
(617 to 860)

High risk of healing4

650 per 1000

852 per 1000
(736 to 935)

Amputation
Follow‐up: mean 16 weeks

Study population

RR 0.40
(0.17 to 0.95)

341
(1 study)

⊕⊕⊝⊝
low2,6

101 per 1000

40 per 1000
(17 to 96)

Moderate

*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; HR: Hazard 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 There was the potential for performance bias as unblinded health professionals were able to make decisions about undertaking closure surgery that could then have resulted more wounds being closed (and classed as healed) or amputated in one group compared with the other.
3 The confidence interval around the estimate of relative risk is consistent with a 11% relative increase in healing with NPWT to a 101% relative increase in risk of healing with NPWT.
4 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.
5 The confidence interval around the estimate hazard ratio is consistent with a 27% relative increase in the hazard of healing with NPWT to a 160% relative increase in the hazard of healing with NPWT.
6 The confidence interval around the estimate of relative risk is consistent with a 83% relative reduction in amputation risk with NPWT to a 5% relative reduction in amputation risk with NPWT.

Figures and Tables -
Summary of findings 2. NPWT compared to Moist dressings for debrided foot ulcers in people with diabetes
Summary of findings 3. NPWT compared to Gauze dressings for debrided foot ulcers in people with diabetes

NPWT compared to Gauze dressings for debrided foot ulcers in people with diabetes

Patient or population: patients with debrided foot ulcers in people with diabetes
Settings:
Intervention: NPWT
Comparison: Gauze dressings

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Gauze dressings

NPWT

Proportion of wounds healed
Follow‐up: mean 30 days

Low risk of healing1

RR 0.38
(0.05 to 2.59)

15
(1 study)

⊕⊝⊝⊝
very low2,3

340 per 1000

129 per 1000
(17 to 881)

Moderate risk of healing1

530 per 1000

201 per 1000
(27 to 1000)

High risk of healing1

650 per 1000

247 per 1000
(33 to 1000)

*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 Several domain had unclear risk of bias recorded.
3 The confidence interval around the estimate of relative risk is consistent with a 95% relative reduction in risk of healing with NPWT to a 159% relative increased risk of healing with NPWT.

Figures and Tables -
Summary of findings 3. NPWT compared to Gauze dressings for debrided foot ulcers in people with diabetes
Table 1. Overview of trials

Armstrong 2005

16 weeks

Diabetic foot amputation to trans‐metatarsal level

Group A: moist wound therapy with alginates, hydrocolloid, foam or hydrogel dressings (n = 85)

Group B: NPWT (VAC system, dressing changes every 48 h. Treatment conducted until wound closure or completion of 112‐day assessment (n = 77)

Number of wounds completely healed

Group A: 33/85 (38.8%)

Group B: 43/77 (55.8%)

Of healed wounds —healed by secondary intention (without primary/surgical wound closure)

Group A: 25/33 (75.8%)

Group B: 31/43 (72.1%)

Remaining wounds were closed following surgery.

Time to wound healing

median time to healing

Group A: 77 days (IQR 40 to 122)

Group B: 56 days (IQR 26 to 92)

Log rank = p = 0.005

Amputation

Number of participants undergoing further amputation

Group A: 9/85 (10.6%)

Major = 5/Minor = 4

Group B: 2/77 (2.3%)

Major = 0/Minor = 2

There was no difference noted in time to healing for acute or chronic wounds.

Adverse events

Participants who had one or more adverse events

Group A: 46/85 (54.1%)

Group B: 40/77 (51.9%)

Participants who had one or more treatment‐related adverse events

Group A: 11/85 (12.9%)

5 classified as serious

Group B: 9/77 (11.7%)

1 classified serious

Resource use

Average total cost per participant

Group A: USD 36,887

Group B: USD26,972

Average total direct cost per participants for those treated for 8 weeks or longer

Group A: USD 36,096

Group B: USD 27,270

Average per participant cost to achieve 100% healing

Group A: USD 38,806

Group B: USD 25,954

Blume 2008

16 weeks

Ulceration of the foot in people with diabetes

Group A: advanced moist wound therapy dressings used according to guidelines/local protocols (n = 169)

Group B: NPWT (VAC system), applied according to manufacturer’s instructions. (n = 172)

Number of wounds completely healed (six participants excluded in paper as did not receive treatment, added back into denominator here)

Group A: 48/169 (28.4%)

Group B: 73/172 (42.4%)

Proportion of wounds closed using surgery (unclear if considered part of healed group)

Group A: 14/169 (8.3%)

Group B: 16/172 (9.3%)

Time to wound healing

median time to healing

Group A: could not be estimated

Group B: 96 days (95% CI 75.0 to 114.0)

Log rank taken as P value 0.001

Amputation

Number of participants undergoing amputation*

Group A: 17/169 (10.1%)

Major = 4; minor = 13

Group B: 7/172 (4.1%)

Major = 5; minor = 2

Adverse events

Limited data: not extracted

Resource use – taken from conference abstract that we think is related to this main publication.

Mean estimated total costs of inpatient services per participant

Group A: USD 8570 (95%CI USD 5922 to USD 11,432)

Group B: USD 5206 (95%CI USD 3172 to USD 7561)

Karatepe 2011

Not specified. Last assessment one month after healing

Diabetic foot ulcers

Group A: conventional wound care treatment: based on text in report taken to be dry gauze (n = 37)

Group B: NPWT (VAC system) (n = 30)

Time to healing

Median time to healing

Group A: 4.4 weeks

Group B: 3.9 weeks

Mean value presented but not extracted.

No specific P value presented

Health‐related quality of life

SF‐36: Data not presented.

Mody 2008

Not specified: until healing or loss to follow‐up

Diabetic foot ulcers

Group A: wet‐to‐dry gauze (n = 9)

Group B: locally‐constructed NPWT (n = 6)

Number of wounds completely healed

By secondary intention:

Group A: 1/9 (11.0%)

Group B: 1/6 (16.6%)

By delayed primary closure:

Group A: 3/9 (33%)

Group B: 0/6 (0%)

Novinščak 2010

2 months

Complicated diabetic foot ulcers

Group A: classic gauze (n = 8)

Group B: dressings (moist) (n = 12)
Group C: NPWT (n = 7)

Healing rate (percentage with wound closure – defined by author on contact)

Group A: 4/8* (50%)

Group B: 9/12* (75%)

Group C: * could not be calculated (90%)

*Figure calculated by review author as only proportions obtained from study author

Figures and Tables -
Table 1. Overview of trials
Comparison 1. NPWT compared with moist (non‐gauze) wound dressings

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of wounds healed Show forest plot

2

503

Risk Ratio (M‐H, Fixed, 95% CI)

1.47 [1.18, 1.84]

2 Time to healing Show forest plot

2

Hazard Ratio (Fixed, 95% CI)

1.85 [1.40, 2.45]

3 Amputations Show forest plot

2

503

Risk Ratio (M‐H, Fixed, 95% CI)

0.35 [0.17, 0.74]

4 Adverse events Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

4.1 All adverse events

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 Treatment‐related adverse events

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figures and Tables -
Comparison 1. NPWT compared with moist (non‐gauze) wound dressings
Comparison 2. NPWT compared with gauze dressings

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of wounds healed Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Figures and Tables -
Comparison 2. NPWT compared with gauze dressings