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Referencias

Barth 1991 {published data only}

Barth R, Campbell LV, Allen S, Jupp JJ, Chisholm DJ. Intensive education improves knowledge, compliance and foot problems in type 2 diabetes. Diabetic Medicine 1991;8:111‐17.

Bloomgarden 1987 {published data only}

Bloomgarden ZT, Karmally W, Metzger MJ, Brothers M, Nechemias C, Bookman J, et al. Randomized controlled trial of diabetic patient education: improved knowledge without improved metabolic status. Diabetes Care 1987;10(3):263‐72.

Borges 2004 {published data only}

Borges WJ. The impact of a brief foot care intervention for persons with diabetes [PhD thesis]. University of Texas Health Science Center at Houston School of Nursing, doctoral dissertation, 2004.
Borges WJ, Ostwald SK. Improving foot self‐care behaviors with Pies Sanos. Western Journal of Nursing Research 2008;30(3):325‐41.

Cisneros 2010 {published data only}

Cisneros LL. Evaluation of a neuropathic ulcers prevention program for patients with diabetes [Avaliação de um programa para prevenção de úlceras neuropáticas em portadores de diabetes]. Revista brasileira de fisioterapia 2010;14(1):31‐7.

Corbett 2003 {published and unpublished data}

Corbett CF. A randomized pilot study of improving foot care in home health patients with diabetes. The Diabetes Educator 2003;29:273‐82.

Frank 2003 {published data only}

Frank KI. Self‐management of foot care for patients 65 years of age or older with diabetes. Dissertation Abstracts International2003; Vol. 64‐10, issue B:4863.

Kruger 1992 {published data only}

Kruger S, Guthrie D. Foot care: knowledge retention and self‐care practices. The Diabetes Educator 1992;18(6):487‐90.

Lincoln 2008 {published data only}

Lincoln NB, Radford KA, Game FL, Jeffcoate WJ. Education for secondary prevention of foot ulcers in people with diabetes: a randomised controlled trial. Diabetologia 2008;51(11):1954‐61.

Malone 1989 {published data only}

Malone JM, Snyder M, Anderson G, Bernhard VM, Holloway GA, Bunt TJ. Prevention of amputation by diabetic education. The American Journal of Surgery 1989;158:520‐4.

Mazzuca 1986 {published and unpublished data}

Mazzuca SA, Moorman NH, Wheeler ML, Norton JA, Fineberg NS, Vinicor F, et al. The diabetes education study: a controlled trial of the effects of diabetes patient education. Diabetes Care 1986;9(1):1‐10.

Rettig 1986 {published data only}

Rettig BA, Shrauger DG, Recker RR, Gallagher TF, Wiltse H. A randomized study of the effects of a home diabetes education program. Diabetes Care 1986;9(2):173‐8.

Rönnemaa 1997 {published and unpublished data}

Hämäläinen H, Rönnemaa T, Toikka T, Liukkonen I. Long‐term effects of one year of intensified podiatric activities on foot‐care knowledge and self‐care habits in patients with diabetes. The Diabetes Educator 1998;24(6):734‐40.
Rönnemaa T, Hämäläinen H, Toikka T, Liukkonen I. Evaluation of the impact of podiatrist care in the primary prevention of foot problems in diabetic subjects. Diabetes Care 1997;20(12):1833‐7.
Rönnemaa T, Liukkonen I, Knuts L‐R, Seppälä P, Kallio V. Prevalence of foot problems and need for foot care in an unselected diabetic population. The Journal of British Podiatric Medicine 1993;48(12):185‐90.

Dargis 1999 {published data only}

Dargis V, Pantelejeva O, Jonushaite A, Vileikyte L, Boulton AJM. Benefits of a multidisciplinary approach in the management of recurrent diabetic foot ulceration in Lithuania ‐ a prospective study. Diabetes Care 1999;22:1428‐31.

Davidson 2000 {published data only}

Davidson MB, Karlan VJ, Hair TL. Effect of a pharmacist‐managed diabetes care program in a free medical clinic. American Journal of Medical Quality 2000;15:137‐41.

De Weerdt 1991 {published data only}

Weerdt I de, Visser AP, Kok GJ, Weerdt O de, Veen EA van der. Randomized controlled multicentre evaluation of an education programme for insulin‐treated diabetic patients: effects on metabolic control, quality of life, and costs of therapy. Diabetic Medicine 1990;8:338‐45.

Donohoe 2000 {published data only}

Donohoe ME, Fletton JA, Hook A, Powell R, Robinson I, Stead JW, et al. Improving foot care for people with diabetes mellitus ‐ a randomized controlled trial of an integrated care approach. Diabetic Medicine 2000;17:581‐7.

Fresenius 2009 {published data only}

Fresenius K, Kramer I. Implementation and evaluation of pharmaceutical care on the outcomes of patients suffering from diabetic foot syndrome. Krankenhauspharmazie 2009;30(1):2‐10.

Glasgow 1992 {published data only}

Glasgow RE, Toobert DJ, Hampson SE, Brown JE, Lewinsohn PM, Donnelly J. Improving self‐care among older patients with type II diabetes: the 'sixty something...' study. Patient Education and Counseling 1992;19:61‐74.

Litzelman 1993 {published data only}

Litzelman DK, Slemenda CW, Langeveld CD, Hays LM, Welch MA, Bild DE, et al. Reduction of lower extremity clinical abnormalities in patients with non‐insulin‐dependent diabetes mellitus. Annals of Internal Medicine 1993;119(1):36‐41.

Litzelman 1997 {published data only}

Litzelman DK, Marriot DJ, Vinicor F. The role of footwear in the prevention of foot lesions in patients with NIDDM. Diabetes Care 1997;20(2):156‐62.

McCabe 1998 {published data only}

McCabe CJ, Stevenson RC, Dolan AM. Evaluation of a diabetic foot screening and protection programme. Diabetic Medicine 1998;15:80‐4.

McMurray 2002 {published data only}

McMurray SD, Johnson G, Davis S, McDougall K. Diabetes education and care management significantly improve patient outcomes in the dialysis unit. American Journal of Kidney Diseases 2002;40:566‐75.
McMurray SD, McDougall K. Improving diabetes foot care in the dialysis facility. Nephrology News & Issues 2003;17(10):57,60‐1,65‐6.

Nesari 2010 {published data only}

Nesari M, Zakerimoghadam M, Rajab A, Bassampour S, Faghihzadeh S. Effect of telephone follow‐up on adherence to a diabetes therapeutic regimen. Japan Journal of Nursing Science 2010;7(2):121‐8.

Pieber 1995 {published data only}

Pieber TR, Holler A, Siebenhofer A, Brunner GA, Semlitsch B, Schattenberg S, et al. Evaluation of a structured teaching and treatment programme for type 2 diabetes in general practice in a rural area of Austria. Diabetic Medicine 1995;12:349‐54.

Plank 2003 {published data only}

Plank J, Haas W, Rakovac I, Gorzer E, Sommer R, Siebenhofer A, et al. Evaluation of the impact of chiropodist care in the secondary prevention of foot ulcerations in diabetic subjects. Diabetes Care 2003;26:1691‐5.

Reichard 1993 {published data only}

Reichard P, Nilsson BY, Rosenqvist U. The effect of long‐term intensified insulin treatment on the development of microvascular complications of diabetes mellitus. New England Journal of Medicine 1993;329(5):304‐9.

Schiel 2004 {published data only}

Schiel R, Braun A, Müller R, Helbich C, Siefke S, Franke I, et al. A structured treatment and educational program for patients with type 2 diabetes mellitus, insulin therapy and impaired cognitive function (DikoL) [Ein strukturiertes behandlung‐ und schulungsprogramm für patienten mit typ‐2‐diabetes mellitus, insulintherapie und verminderten kognitiver leistungsfähigkeit (DikoL)]. Medizinische Klinik 2004;99(6):285‐92.

Vinicor 1985 {published data only}

Vinicor F, Cohen SJ, Mazzuca SA, Moorman N, Wheeler M, Kuebler T, et al. DIABEDS: a randomized trial of the effects of physician and/or patient education on diabetes patient outcomes. Journal of Chronic Disease 1987;40(4):345‐56.

Ward 1999 {published data only}

Ward A, Metz L, Oddone EZ, Edelman D. Foot education improves knowledge and satisfaction among patients at high risk for diabetic foot ulcer. Diabetes Educator 1999;25(4):560‐7.

Wooldridge 1996 {published data only}

Wooldridge J, Bergeron J, Thornton C. Preventing diabetic foot disease: lessons from the Medicare therapeutic shoe demonstration. American Journal of Public Health 1996;86(7):935‐8.

Zhenghua 2011 {published data only}

Zhenghua X, Dingyu C, Qiling Y, Qian Z, Jin X, Chunling H,  et al. Individualised diabetic education can contribute to decrease the incidence of diabetic foot and avoid amputation: Results of a 9‐year prospective study. Diabetologia 2011;54:S32.

References to studies awaiting assessment

Gershater 2011 {published data only}

Gershater MA, Pilhammar E, Apelqvist J, Alm‐Roijer C. Patient education for the prevention of diabetic foot ulcers. Interim analysis of a randomised controlled trial due to morbidity and mortality of participants. European Diabetes Nursing  2011;8(3):102‐107b.

American Diabetes Association 2007

American Diabetes Association. Standards of medical care in diabetes ‐ 2007. Diabetes Care 2007;30(Suppl 1):S4‐S41.

Apelqvist 1993

Apelqvist J, Larsson J, Agardh CD. Long‐term prognosis for diabetic patients with foot ulcers. Journal of Internal Medicine 1993;233:485‐91.

Armstrong 1998

Armstrong DG, Lavery LA. Diabetic foot ulcers: prevention, diagnosis and classification. American Family Physician 1998;57:1325‐32.

Assal 1985

Assal JP, Mühlhauser I, Pernet A, Gfeller R, Jörgens V, Berger M. Patient education as the basis for diabetes care in clinical practice and research. Diabetologia 1985;28:602‐13.

Bild 1989

Bild DE, Selby JV, Sinnock P, Browner WS, Braveman P, Showstack JA. Lower‐extremity amputation in people with diabetes. Epidemiology and prevention. Diabetes Care 1989;12:24‐31.

Boulton 1995

Boulton AJM. Why bother educating the multi‐disciplinary team and the patient ‐ the example of prevention of lower extremity amputation in diabetes. Patient Education and Counseling 1995;26:183‐8.

Boulton 2004

Boulton AJ, Kirsner RS, Vileikyte L. Clinical practice. Neuropathic diabetic foot ulcers. New England Journal of Medicine 2004;351(1):48‐55.

Boulton 2005

Boulton AJ, Vileikyte L, Ragnarson‐Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet 2005;366(9498):1719‐24.

Bowering 2001

Bowering CK. Diabetic foot ulcers. Pathophysiology, assessment, and therapy. Canadian Family Physician 2001;47:1007‐16.

Campbell 2004

Campbell MK, Elbourne DR, Altman DG, CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ 2004;328(7441):702‐8.

Canavan 2008

Canavan RJ, Unwin NC, Kelly WF, Connolly VM. Diabetes‐ and nondiabetes‐related lower extremity amputation incidence before and after the introduction of better organized diabetes foot care: continuous longitudinal monitoring using a standard method. Diabetes Care 2008;31(3):459‐63.

Cavanagh 2005

Cavanagh PR, Lipsky BA, Bradbury AW, Botek G. Treatment for diabetic foot ulcers. Lancet 2005;366(9498):1725‐35.

Colagiuri 2009

Colagiuri R, Eigenmann CA. A national consensus on outcomes and indicators for diabetes patient education. Diabetic Medicine 2009;26(4):442‐6.

De Sonnaville 1997

De Sonnaville JJ, Colly LP, Wijkel D, Heine RJ. The prevalence and determinants of foot ulceration in type 2 diabetic patients in a primary health care setting. Diabetes Research and Clinical Practice 1997;35:149‐56.

Deyo 1998

Deyo RA, Battie M, Beurskens AJ, Bombardier C, Croft P, Koes B, et al. Outcome measures for low back pain research. A proposal for standardized use. Spine 1998;23(18):2003‐13.

Dinh 2005

Dinh TL, Veves A. A review of the mechanisms implicated in the pathogenesis of the diabetic foot. International Journal of Lower Extremity Wounds 2005;4(3):154‐9.

Dorresteijn 2010a

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]

Duke 2009

Duke SA, Colagiuri S, Colagiuri R. Individual patient education for people with type 2 diabetes mellitus. Cochrane Database of Systematic Reviews 2009, Issue 1. [DOI: 10.1002/14651858.CD005268.pub2]

Edmonds 1996

Edmonds ME, Van Acker K, Foster AVM. Education and the diabetic foot. Diabetic Medicine 1996;13:S61‐S64.

Edmonds 2006

Edmonds ME, Foster AV. Diabetic foot ulcers. BMJ 2006;332(7538):407‐10.

Frykberg 2006

Frykberg RG, Zgonis T, Armstrong DG, Driver VR, Giurini JM, Kravitz SR, et al. Diabetic foot disorders. A clinical practice guideline (2006 revision). The Journal of Foot and Ankle Surgery 2006;45(5 Suppl):S1‐66.

Gibson 2002

Gibson PG, Coughlan J, Wilson AJ, Hensley MJ, Abramson M, Bauman A, et al. The effects of limited (information only) patient education programs on the health outcomes of adults with asthma. Cochrane Database of Systematic Reviews 2002, Issue 1. [DOI: 10.1002/14651858.CD001005]

Global Lower Extremity Amputation Study Group 2000

Global Lower Extremity Amputation Study Group. Epidemiology of lower extremity amputation in centres in Europe, North America and East Asia. The British Journal of Surgery 2000;87(3):328‐37.

Haines 2009

Haines T, Gross A, Burnie SJ, Goldsmith CH, Perry L. Patient education for mechanical neck disorders. Cochrane Database of Systematic Reviews 2009, Issue 1. [DOI: 10.1002/14651858.CD005106.pub3]

Higgins 2011

Higgins JPT, Altman DG, Sterne JAC. 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). Available from www.cochrane‐handbook.orgThe Cochrane Collaboration, 2011.

Icks 2009

Icks A, Haastert B, Trautner C, Giani G, Glaeske G, Hoffmann F. Incidence of lower‐limb amputations in the diabetic compared to the non‐diabetic population. Findings from nationwide insurance data, Germany, 2005‐2007. Experimental and Clinical Endocrinology and Diabetes 2009;117(9):500‐4.

IDF clinical guidelines task force 2005

IDF Clinical Guidelines Task Force. Global Guideline for Type 2 Diabetes. Brussels: International Diabetes Federation2005.

Jeffcoate 2003

Jeffcoate WJ, Harding KG. Diabetic foot ulcers. Lancet 2003;361(9368):1545‐51.

Larsson 1995

Larsson J, Apelqvist J. Towards less amputations in diabetic patients. Incidence, causes, cost, treatment, and prevention ‐ a review. Acta Orthopaedica Scandinavica 1995;66:181‐92.

Levin 1995

Levin ME. Preventing amputation in the patient with diabetes. Diabetes Care 1995;18:1383‐94.

Majid 2000

Majid M, Cullum N, O'Meara S Sheldon T. Systematic reviews of wound care management: (4) diabetic foot ulceration. Health Technology Assessment 2000;21:113‐238.

Mason 1999

Mason J, O'Keeffe C, McIntosh A, Hutchinson A, Booth A, Young RJ. A systematic review of foot ulcer in patients with type 2 diabetes mellitus. I: prevention. Diabetic Medicine 1999;16:801‐12.

Mayfield 1998

Mayfield JA, Reiber GE, Sanders LJ, Janisse D, Pogach LM. Preventive foot care in people with diabetes. Diabetes Care 1998;21:2161‐77.

Most 1983

Most RS, Sinnock P. The epidemiology of lower extremity amputations in diabetic individuals. Diabetes Care 1983;6:87‐91.

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.

Pecoraro 1990

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

Ragnarson Tennvall 2004

Ragnarson Tennvall G, Apelqvist J. Health‐economic consequences of diabetic foot lesions. Clinical Infectious Diseases 2004;39(Suppl 2):S132‐9.

Reed 2005

Reed D, Price EG, Windish DM, Wright SM, Gozu A, Hsu EB, et al. Challenges in systematic reviews of educational intervention studies. Annals of Internal Medicine 2005;142(12 Pt 2):1080‐9.

Reenders 1993

Reenders K, de Nobel E, van den Hoogen HJM, Rutten GEHM, van Weel C. Diabetes and its long‐term complications in general practice: a survey in a well‐defined population. Family Practice 1993;10:169‐72.

Rith‐Najarian 2000

Rith‐Najarian SJ, Reiber GE. Prevention of foot problems in persons with diabetes. Journal of Family Practice 2000;49(11 Suppl):S30‐9.

Robbins 2008

Robbins JM, Strauss G, Aron D, Long J, Kuba J, Kaplan Y. Mortality rates and diabetic foot ulcers: is it time to communicate mortality risk to patients with diabetic foot ulceration?. Journal of the American Podiatric Medical Association 2008;98(6):489‐93.

Schellings 2005

Schellings R, Kessels AG, Ter Riet G, Kleijnen J, Leffers P, Knottnerus JA, et al. Members of research ethics committees accepted a modification of the randomized consent design. Journal of Clinical Epidemiology 2005;58(6):589‐94.

Schultz 2010

Schulz KF, Altman D, Moher D, for the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Annals of Internal Medicine 2010;152(11):1‐7.

Singh 2005

Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA 2005;293(2):217‐28.

St Vincent Declaration 1989

World Health Organization (Europe) and International Diabetes Federation (Europe). Diabetes care and research in Europe: the Saint Vincent Declaration. Diabetic Medicine 1990;7(4):360.

van Tulder 1997

Tulder van MW, Assendelft WJJ, Koes BW, Bouter LM. Method guidelines for systematic reviews in the Cochrane Collaboration Back Review Group for Spinal Disorders. Spine 1997;22:2323‐30.

Vileikyte 2001

Vileikyte L. Diabetic foot ulcers: a quality of life issue. Diabetes/Metabolism Research and Reviews 2001;17(4):246‐9.

Wu 2007

Wu SC, Driver VR, Wrobel JS, Armstrong DG. Foot ulcers in the diabetic patient, prevention and treatment. Vascular Health and Risk Management 2007;3(1):65‐76.

References to other published versions of this review

Dorresteijn 2010b

Dorresteijn JA,  Kriegsman DM,  Assendelft WJ,  Valk GD. Patient education for preventing diabetic foot ulceration. Cochrane Database of Systematic Reviews 2010, Issue 5. [DOI: 10.1002/14651858.CD001488.pub3]

Dorresteijn 2012

Dorresteijn JA, Kriegsman DM, Assendelft WJ, Valk GD. Patient education for preventing diabetic foot ulceration. Cochrane Database of Systematic Reviews 2012, Issue 10. [DOI: 10.1002/14651858.CD001488.pub4]

Valk 2001

Valk GD,  Kriegsman DM,  Assendelft WJ. Patient education for preventing diabetic foot ulceration. Cochrane Database of Systematic Reviews 2001, Issue 4. [DOI: 10.1002/14651858.CD001488]

Valk 2005

Valk GD,  Kriegsman DM,  Assendelft WJ. Patient education for preventing diabetic foot ulceration. Cochrane Database of Systematic Reviews 2005, Issue 1. [DOI: 10.1002/14651858.CD001488.pub2]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Barth 1991

Methods

RCT

Participants

70 patients with type 2 diabetes mellitus ‐ randomised (intervention 38 vs control 32)
Baseline risk for foot ulceration: PVD, intervention 19 vs control 6. Number of foot problems: 'no significant difference between groups'
Baseline outcome measures: 'No significant difference between groups'
Study setting: secondary outpatient care, outpatient clinic in Australia
Inclusion criteria: people with type 2 diabetes mellitus > 3 months and current treatment > 1 month, sub optimal glucose control, BMI ≥ 25, energy fat intake at least 35%, no education in previous 6 months, competence in English language

Interventions

Intervention group:
Normal patient education programme, consisting of 14 hours group patient education (over 3 consecutive days; groups of 8 to 10 people) including 1‐hour lecture and discussion by podiatrist. Content: standard diabetes education, 1 hour on foot care and footwear
4 weekly group patient education sessions of 1.5 to 2.5 hours (total 9 hours), 3 by podiatrist, 1 by psychologist on the base of cognitive motivation theory. Content: recommendations and foot care education and demonstration and practicing foot care procedures

Control group:
Normal patient education programme, consisting of 14 hours group patient education (over 3 consecutive days; groups of 8 to 10 people) including 1‐hour lecture and discussion by podiatrist. Content: standard diabetes education, 1 hour on foot care and footwear

Adherence: not described

Outcomes

Primary outcomes: not reported
Secondary outcomes: foot care knowledge, behaviour assessment score, foot problems requiring treatment

Duration and completion of follow‐up

6 months; 62 people completed follow‐up (intervention 33 vs control 29)

Types of assessment

Outcomes measured by multiple choice questions on knowledge and compliance. Number of questions and range of outcomes not reported

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No information provided

Allocation concealment (selection bias)

Unclear risk

No information provided

Blinding (performance bias and detection bias)
Blinding of outcome assessors

Low risk

Foot care knowledge and foot care routine compliance were assessed with a questionnaire using multiple choice answers. Foot problems were scored by an independent podiatrist, who was not aware of the patients' experimental conditions

Incomplete outcome data (attrition bias)
All outcomes

High risk

62 of 70 people completed 6 months' follow‐up (intervention 33 vs control 29). Reasons for missing outcome data are described and are unlikely to be related to the outcome

No ITT analyses were undertaken

Selective reporting (reporting bias)

Low risk

No study protocol available, but the trial report lists the outcomes of interest in both the methods and the results section

Other bias

High risk

Baseline risk for foot ulceration: PVD, intervention 19 vs control 6 (P < 0.05)
Number of foot problems: 'No significant difference between groups'

Co‐interventions were not described

Adherence to the intervention was not described

Bloomgarden 1987

Methods

RCT

Participants

749 insulin‐treated people with diabetes mellitus randomised: 345 consented to participate:
intervention 165 vs control 180

Baseline risk for foot ulceration:
146 people had no foot lesion at initial evaluation, intervention 83 vs control 63
100 people had callus, nail dystrophy or fungal infection at initial evaluation, intervention 37 vs control 63
20 people had an ulcer or amputation at initial evaluation, intervention 7 vs control 13

Study setting: primary care, diabetes clinic in the USA
Inclusion criteria: insulin‐treated diabetes mellitus (unclear which type of diabetes)

Interventions

I: 9 group patient education sessions by nurse educator and nutritionist using film and card games and individual instruction. Content: 1 group session of education on foot care and skin hygiene, the other sessions on understanding diabetes, basic nutrition, weight loss, food purchasing, meal planning, insulin administration, emergencies, risk factors for macrovascular disease and individual diet instruction

C: usual care. Content: not specified

Adherence: 82 (50%) intervention group people completed 7 or more educational group sessions

Outcomes

Primary outcomes: ulcer or amputations
Secondary outcomes: callus, nail dystrophy or fungal infection, behaviour assessment score

Duration and completion of follow‐up

Intervention 1.6 ± 0.3 years vs control 1.5 ± 0.3 years; 266 people completed follow‐up: intervention 127 vs control 139

Types of assessment

Behaviour assessment score: 7 questions of which 1 on foot care

Notes

The reported outcome data on knowledge scores are not included in this review, because the assessment tool only included questions about diabetes in general, but not on foot care

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No information provided

Allocation concealment (selection bias)

Unclear risk

No information provided

Blinding (performance bias and detection bias)
Blinding of outcome assessors

Unclear risk

No information provided

Incomplete outcome data (attrition bias)
All outcomes

High risk

266 of 345 people completed follow‐up (intervention 127 vs control 139). Reasons for missing outcome data are described and are unlikely to be related to the outcome. Note: 749 people were originally randomised, but 193 did not attend the clinic during the period of the study and 211 of those who did attend to the clinic declined to participate, leaving only 345 study subjects

No ITT analyses were undertaken

Selective reporting (reporting bias)

Unclear risk

Unclear. No study protocol available. The outcomes ulcer and amputation incidence, callus, nail dystrophy, fungal infection and behaviour assessment score were not prespecified in the methods section of the study report, but this is more likely to be a result of insufficient rather than selective reporting

Other bias

High risk

Baseline risk for foot ulceration:
146 people had no foot lesion at initial evaluation, intervention 83 vs control 63
100 people had callus, nail dystrophy or fungal infection at initial evaluation, intervention 37 vs control 63
20 people had an ulcer or amputation at initial evaluation, intervention 7 vs control 13

Co‐interventions were not described

Adherence: 82 (50%) intervention group people completed 7 or more educational group sessions

Borges 2004

Methods

RCT

Participants

167 people with type 2 diabetes randomised: intervention 55, only RA 55, control 57

Baseline risk for foot ulceration: no data provided
Baseline outcome measures: patients' behaviour assessment scores: intervention 4.7, RA 4.8, control 5.1. Foot care knowledge scores: no significant differences. Self‐efficacy scores: no significant differences
Study setting: 2 community hospital emergency departments near the USA‐Mexico border

Inclusion criteria: people with type 2 diabetes, age 40 years or older, residing within the country, presenting at the emergency department with non‐emergent health problems, not having active foot ulceration or other foot pathology, able to communicate verbally, agreeing on a home visit

Interventions

Intervention group:
Lower extremity amputation risk assessment. Content: use of a monofilament
15‐minute foot self‐care education session by the researcher. Content: information about the patients' risk assessment score, recommendations for foot self‐care based on the individual risk score, a discussion about the barriers to optimal self‐care and an outline of the importance of daily foot self‐care

Risk assessment group: lower extremity amputation risk assessment. Content: use of a monofilament

Control group:

No intervention

Adherence: no data provided, but likely that all intervention group people received the single brief educational session directly after randomisation

Outcomes

Primary outcomes: not reported
Secondary outcomes: foot care knowledge scores, patients' behaviour assessment scores (self‐reported and observed)

Duration and completion of follow‐up

1 month; 141 people completed follow‐up: intervention 47, RA 48, control 46

Types of assessment

Foot care knowledge scores: 5‐item foot care subscale from the Diabetes Knowledge Questionnaire 24
Self‐reported self‐care behaviour: SDSCA questionnaire
Observed self‐care behaviour: self developed 16‐item observation guide

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No information provided

Allocation concealment (selection bias)

Unclear risk

No information provided

Blinding (performance bias and detection bias)
Blinding of outcome assessors

Low risk

The research assistant, who was the outcome assessor, was masked to group assignment

Incomplete outcome data (attrition bias)
All outcomes

High risk

141 of 167 people completed 1‐month follow‐up (intervention 47, RA 48, control 46). Dropout was balanced in numbers across intervention groups, but reasons for missing data were not reported

No ITT analyses were undertaken

Selective reporting (reporting bias)

Low risk

No study protocol available, but the trial report lists the outcomes of interest in both the methods and the results section

Other bias

Unclear risk

Baseline risk for foot ulceration: no data provided

There were no co‐interventions

Adherence: no data provided, but likely that all intervention group people received the single brief educational session directly after randomisation

Cisneros 2010

Methods

RCT

Participants

53 people with type 1 and 2 diabetes randomised: intervention 30 vs control 23

Baseline risk for foot ulceration:
35 people had no history of foot ulceration, intervention 21 vs control 14. 16 people had risk 1 (only insensitivity), intervention 6 vs control 10
22 people had risk 2 (insensitivity and plantar overpressure or deformity), intervention 15 vs control 7
6 people had risk 3 (insensitivity and previous ulcers), intervention 3 vs control 3
9 people had risk 4 (insensitivity, previous ulcers and plantar overpressure), intervention 6 vs control 3

Baseline outcome measures: no data provided.

Study setting: a unit of the National Health System (SUS) in Porto Alegre, Rio Grande do Sul, Brazil

Study setting: community‐based care. Participants were selected from the National Health System (SUS) database

Inclusion criteria: diabetes type 1 or 2, presence of neuropathy caused exclusively by diabetes mellitus as evidenced by inability to feel a Semmes‐Weinstein 5.07 monofilament in 2 of 3 of the following sites: digital pulp of the hallux, the head of the first metatarsal and the head of the fifth metatarsal

Interventions

Intervention group:

  • therapeutic education. Content: four 90‐minute group meetings with up to 8 participants, conducted by the researcher. Topics were diabetes complications, disease treatments, inspection and foot hygiene, or choice and use of footwear. Specially prepared games were used as teaching aids with questions on the issue at the end of each meeting,

  • protective footwear, 1 pair at the beginning of the study and another pair after completion of the training programme. The participants could choose between 2 models and different colours.

Control group:

  • routine care,

  • instructions on foot care and use of footwear when requested during individual consultations with the researcher.

Adherence: of the 30 intervention group participants, 1 withdrew before completion of the education programme and 29 completed the education programme and received protective shoes. Of the 29 participants, 34.5% wore them daily up to 6 hours, 37.9% wore them daily for more than 6 hours and 27.6% did not wear the shoes daily

Outcomes

Primary outcomes: foot ulceration, foot ulcer recurrence
Secondary outcomes: not reported

Duration and completion of follow‐up

2 years. 35 participants completed follow‐up: intervention 21 vs control 14

Types of assessment

Inspection of the feet for the occurrence of neuropathic injury during individual consultations with the researcher, held quarterly in the first 18 months and after 2 years' follow‐up

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Methods are not described

Allocation concealment (selection bias)

Unclear risk

Methods are not described

Blinding (performance bias and detection bias)
Blinding of outcome assessors

High risk

Both participants and the outcome assessor were not blinded due to the nature of the intervention

Incomplete outcome data (attrition bias)
All outcomes

High risk

The proportion of people lost to follow‐up, although balanced between groups, could have induced clinically relevant bias. In I 9 out of 30 participants were censored (30%) and in C 9 out of 23 (39%)

Selective reporting (reporting bias)

Low risk

No study protocol available, but the trial report lists the outcomes of interest in both the methods and the results section

Other bias

Unclear risk

Baseline risk for foot ulceration: the intervention group consisted of more men (intervention 70% vs control 52%), was older (mean age intervention 64.4 years vs control 59.8 years) and appeared to be at higher risk for foot ulceration (risk categories 1 to 4, intervention 20%, 50%, 10%, 20% vs control 43%, 30%, 13%, 13%). Baseline imbalances were not statistically significant and were not adjusted for

Co‐interventions: not described

Adherence: of the 30 participants, 1 withdrew before completion of the education programme and 29 completed the education programme and received protective shoes

Corbett 2003

Methods

RCT

Participants

40 people with type 2 diabetes mellitus randomised: intervention 20 vs control 20

Baseline risk for foot ulceration:
70% had loss of protective sensation
67% had impaired lower extremity circulation
50% had a foot deformity
Foot risk assessment: no significant differences between groups

Baseline outcome measures: no significant differences between groups
Study setting: community‐based care, people with type 2 diabetes mellitus admitted to home care in the USA

Inclusion criteria: physically and mentally able to participate, able to read and understand English, age 18 years or older, no lower‐extremity ulcer, no history of lower‐extremity amputation

Interventions

Intervention group:
10 to 20 minutes' individualised patient education including verbal and written instructions according to participants' risk factors and foot care knowledge, self‐efficacy and reported self‐care behaviour by research nurse. Content: foot care education topics: individual risk factors, washing and drying feet, toenail care, footwear, moisturising feet, reportable foot problems. If desired: demonstration of nail trimming and problem‐solving discussion to discover alternative care solutions

Control group:

No intervention

Adherence: 19 of 20 intervention group people attended the single education session

Outcomes

Primary outcomes: not reported
Secondary outcomes: foot care knowledge score, foot care practice score, patients' self confidence scores

Duration and completion of follow‐up

6 weeks after the intervention (people were enrolled in the study already 6 weeks prior to the intervention to ensure proper baseline measurements); 35 people completed follow‐up intervention 19 vs control 16

Types of assessment

Foot care knowledge assessment: 7 questions with 4 choices; foot care practice assessment: 7 questions with 4 choices; patients' self confidence assessment: 7 aspects of foot care rated on a 6‐point scale

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomly drawing labelled consent forms, the sequence having been generated by shuffling

Allocation concealment (selection bias)

Low risk

Consent form labels were covered by opaque stickers and randomly shuffled

Blinding (performance bias and detection bias)
Blinding of outcome assessors

Unclear risk

No information provided

Incomplete outcome data (attrition bias)
All outcomes

High risk

35 of 40 people completed follow‐up (intervention 19 vs control 16). Reasons for missing data were not reported
No ITT analyses were undertaken

Selective reporting (reporting bias)

Low risk

No study protocol available, but the trial report lists the outcomes of interest in both the methods and the results section

Other bias

Unclear risk

Baseline foot risk assessment: 'no significant differences between groups'
Co‐interventions were not described
Adherence: 19 of 20 intervention group people attended the single education session

Frank 2003

Methods

RCT

Participants

100 people with type 2 diabetes mellitus randomised: intervention 50 vs control 50

Baseline risk for foot ulceration:
Current smoking. intervention 12.5% vs control 16.7%
Mean HbA1c: intervention 7.44 vs control 7.66, P = 0.559
Mean score neuropathy screening questionnaire (0 to 13): intervention 2.46 vs control 2.46, P = 1.00
Mean number of positive sensations of a monofilament on prespecified locations on the foot (0 to 8): intervention 6.06 vs control 5.38, P = 0.215

Baseline outcome measures:

Foot care knowledge scores: intervention 18.65 (SD 2.65) vs control 17.50 (SD 3.14), P = 0.056

Patients' behaviour assessment:

  • checking feet: intervention 5.21 vs control 4.52, P = 0.243

  • washing feet: intervention 5.17 vs control 5.42, P = 0.572

  • applying lotion: intervention 4.54 vs control 4.19, P = 0.560

  • wearing shoes and socks: intervention 3.71 vs control 4.92, P = 0.057

Study setting: primary care (mostly indigent) people with type 2 diabetes visiting a podiatrist in 1 of 2 designated community health centres associated with the Indiana University School of Medicine in Indianapolis, Indiana

Inclusion criteria: > 65 years of age, no previous foot or leg amputation, access to a working telephone, able to understand English

Interventions

Intervention group:
Lower extremity amputation risk assessment. Content: use of a monofilament
Foot care videotape. Content: people demonstrating proper foot care
Bag of foot supplies. Content: soap, towel, socks, mirror, toenail clippers, lotion samples, information on smoking cessation and exercise
Hand‐out. Content: foot care instructions
30‐ to 40‐minute individualised education session by research nurse. Content: persuasion to perform foot care + demonstration of content of bag of foot supplies
Reminder checklist. Content: instructions for daily foot care
Weekly reminder telephone calls. Content: persuasion to perform foot care
Care as usual by a podiatrist

Control group:
Lower extremity amputation risk assessment. Content: use of a monofilament
Weekly telephone calls. Content: only outcome assessment
Care as usual by a podiatrist

Adherence: no data provided, but likely that all intervention group people received the single brief educational session directly after randomisation

Outcomes

Primary outcomes: not reported
Secondary outcomes: foot care knowledge scores, patients' self‐reported foot care behaviour scores

Duration and completion of follow‐up

4 weeks; 96 people completed follow‐up intervention 48 vs control 48

Types of assessment

Foot care knowledge: 26 items, with a ''true'', ''false'' or ''don't know'' answer (range 0 to 26)
Behaviour scores: retrospectively self‐reported. Data collection during weekly telephone calls. Foot care behaviours of interest were checking feet daily for injury, washing and drying feet daily, applying lotion to the feet daily, wear socks and shoes, trimming toenails weekly. Results for each item were presented by the mean number of days per week that people adhered to the desired behaviour (range 0 to 7 per item)

Notes

It was originally intended to report changes in 'weekly trimming of toenails', but this was abandoned, as all people were seen by a podiatrist for trimming of their toenails

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Papers with either 'group A' or 'group B' were drawn from an envelope

Allocation concealment (selection bias)

High risk

The envelope was not sealed

Blinding (performance bias and detection bias)
Blinding of outcome assessors

High risk

Outcomes were assessed by the research nurse, who also performed the educational intervention

Incomplete outcome data (attrition bias)
All outcomes

High risk

96 of 100 people completed 4 weeks' follow‐up (intervention 48 vs control 48)
No ITT analyses were undertaken

Selective reporting (reporting bias)

Low risk

No study protocol available, but the trial report lists the outcomes of interest in both the methods and the results section

Other bias

Unclear risk

Baseline risk for foot ulceration:
Current smoking. intervention 12.5% vs control 16.7%
Mean HbA1c: intervention 7.44 vs control 7.66, P = 0.559
Mean score neuropathy screening questionnaire (0 to 13): intervention 2.46 vs control 2.46, P = 1.00
Mean number of positive sensations of a monofilament on prespecified locations on the foot (0 to 8): intervention 6.06 vs control 5.38, P = 0.215

Co‐interventions were not described

Adherence: no data provided, but likely that all intervention group people received the single brief educational session directly after randomisation

Kruger 1992

Methods

RCT

Participants

50 people with diabetes mellitus randomised: intervention 23 vs control 27

Baseline risk for foot ulceration: no data provided
Study setting: secondary outpatient care in the USA

Inclusion criteria: diabetes duration at least 5 years (unclear which type of diabetes), no frank pathology, entering weekly hospital diabetes programme

Interventions

Intervention group:
1‐week patient education session. Content: education and guidance (unclear by whom) to assist people in achieving higher levels of general diabetes control
Instructional videotape with supplementary explanation from an instructor. Content: usual teaching on foot care
Additional hands‐on learning sessions during the same week. Content: actual foot washing, inspection, assessment, demonstration of care of corns and callus, toenail cutting, identification of potential foot problems, evaluation foot care
Patient education kit. Content: buff pads and mirror
Daily foot check sheets. Content: encouragement to perform daily foot inspection

Control group:
1‐week patient education session. Content: education and guidance (unclear by whom) to assist people in achieving higher levels of general diabetes control
Instructional videotape with supplementary explanation from an instructor. Content: usual teaching on foot care
Daily foot check sheets. Content: encouragement to daily foot inspection

Adherence: no data provided

Outcomes

Primary outcomes: none reported
Secondary outcomes: foot status, foot care knowledge scores, behaviour assessment

Duration and completion of follow‐up

6 months; 30 people completed follow‐up: intervention 15 vs control 15

Types of assessment

Foot status assessment: 67 items
Foot care knowledge assessment: 12‐item test
Behaviour assessment: daily foot check sheets

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

People were allocated to intervention or control on the basis of the week that they entered the diabetes program. The experimental intervention group was developed similarly from the control group on alternate weeks
Quote: "A random selection process determined whether the control or the experimental [intervention] group would begin the study"

Allocation concealment (selection bias)

High risk

Alternation is not an adequate method of allocation concealment

Blinding (performance bias and detection bias)
Blinding of outcome assessors

Unclear risk

No information provided

Incomplete outcome data (attrition bias)
All outcomes

High risk

30 of 50 people completed 6 months' follow‐up (intervention 15 vs control 15). Reasons for dropping out were death (n = 2), not wanting to make an appointment at the scheduled time and moving without leaving a forwarding address (numbers not reported)
No ITT analyses were undertaken

Selective reporting (reporting bias)

Low risk

Yes. No study protocol available, but the trial report lists the outcomes of interest in both the methods and the results section

Other bias

Unclear risk

Baseline risk for foot ulceration: no data provided
Co‐interventions were not described
Adherence: no data provided

Lincoln 2008

Methods

RCT

Participants

178 people with diabetes and a newly healed foot ulcer randomised. Intervention 87 vs control 85. Excluded after randomisation: 6

Baseline risk for foot ulceration:
Loss of 10 g monofilament stimulus perception: intervention 47% vs control 42%
Loss of neuro tip perception: intervention 35% vs control 36%
Loss of vibration perception: intervention 68% vs control 62%
Absent foot pulses: intervention 20% vs control 28%

Baseline outcome measures:
History of foot ulcer: all participants
Site of previous foot ulcer: fore‐foot: intervention 81% vs control 80%. Mid‐ and hind‐foot: intervention 19% vs control 20%
Amputation rate: previous amputation same leg: intervention 20% vs control 12%. Previous amputation other leg: intervention 7% minor, 3% major vs control 6% minor, 3% major
No baseline behaviour assessment scores provided

Study setting: secondary outpatient care: specialist foot clinic in Nottingham, UK

Inclusion criteria: people with newly healed diabetic foot ulcers (ulcer free for 28 days or more), not living in institutions, no history of dementia, no serious medical problems, English speaking or having an English speaking carer, living < 50 miles from the clinic, not included in any other study

Interventions

Intervention group:
Single 1‐hour structured foot care education session by 1 of the researchers during a home visit. Content: explanation of the principal causes of foot ulcers, illustrations of foot lesions, advises on avoiding accidental damage, identification personal risk factors, evaluation of footwear
Hand‐outs. Content: information about the causes of foot ulcers, foot care and ways to reduce the likelihood of accidents
Telephone call 4 weeks after the education session. Content: assessment of the need for clarification and reinforcement of the educational session content

Control group:

Hand‐outs. Content: information about the causes of foot ulcers, foot care and ways to reduce the likelihood of accidents

Adherence: no data provided, but likely that all intervention group people received the 1 hour at home education session

Outcomes

Primary outcomes: ulcer incidence (recurrence), amputation rate

Secondary outcomes: patients' behaviour assessment scores

Duration and completion of follow‐up

6 and 12 months; 168 people completed 12 months' follow‐up for primary outcomes. 138 people completed 12 months' follow‐up for secondary outcomes

Types of assessment

Occurrence of new ulcers and amputation rate: hospital and foot clinic records, supported by questionnaires sent to the patient. At 12 months also corroborated by writing to participants' general practitioners
Patients' behaviour assessment: questionnaire with 29 items (Nottingham Assessment of Functional Footcare), posted to the patient with a reply‐paid envelope

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

The allocation sequence was randomly generated by a computer in advance of the study

Allocation concealment (selection bias)

Low risk

People were allocated after telephoning an independent randomisation centre which held the sequence list

Blinding (performance bias and detection bias)
Blinding of outcome assessors

Low risk

Scoring of ulcer incidence and amputation rate was based on hospital and foot clinic records, supported by questionnaires sent to the patient. In case of discrepancy, the records were rechecked by a blinded observer. The success of blinding was not assessed but it was believed to be complete

Patients' behaviour assessment score was based on questionnaires that were posted to participants and scored by a researcher who was blinded to participants' group allocation

Incomplete outcome data (attrition bias)
All outcomes

Low risk

168 of 178 people completed 12 months' follow‐up for primary outcomes. 138 of 178 people completed 12 months' follow‐up for secondary outcomes. Reasons for dropping out were death (n = 10), illness (n = 2), erroneous double‐recruitment (n = 1), withdrawal of consent (n = 1), not fitting the eligibility criteria (n = 1), not returning questionnaires (n = 22) and incompleteness of the questionnaire answers (n = 2)
An ITT analysis was performed for primary outcomes only

Selective reporting (reporting bias)

Low risk

No study protocol available, but the trial report lists the outcomes of interest in both the methods and the results section

Other bias

Low risk

Baseline risk for foot ulceration:
Loss of 10 g monofilament stimulus perception: intervention 47% vs control 42%
Loss of neuro tip perception: intervention 35% vs control 36%
Loss of vibration perception: intervention 68% vs control 62%
Absent foot pulses: intervention 20% vs control 28%
Co‐interventions included regular podiatry and suitable orthoses when appropriate, but no structured education. The clinical care of people in both groups was unaffected by the study
Adherence: no data provided, but likely that all intervention group people received the 1 hour at home education session

Malone 1989

Methods

RCT

Participants

227 people with diabetes mellitus and foot infection, ulceration or prior amputation ‐ randomised. 203 people included: intervention 103 vs control 100.

Baseline risk for foot ulceration: although described as 'not significant', prior vascular reconstruction higher in control and incidence of foot callus higher in intervention (P < 0.05). No significant differences in foot deformities, neuropathy, gangrene, prior amputation or ulcer and level of distal pulses

Study setting: secondary outpatient care, podiatric or vascular surgery care in the USA

Inclusion criteria: people with diabetes (unclear which type) with foot infection, ulceration or prior amputation referred for podiatry or vascular surgery

Interventions

Intervention group:
1‐hour group patient education with slides given by podiatrist and set of patient instructions. Content: slides of infected diabetic feet and amputated diabetic limbs, simple set of patient instructions for diabetic foot care
Routine patient education. Content: routine diabetic teaching on diet, weight, exercise and medication

Control group:

Routine patient education. Content: routine diabetic teaching on diet, weight, exercise and medication

Adherence: no data provided

Outcomes

Primary outcomes: ulcer incidence, incidence of infections, amputation rate
Secondary outcomes: none

Duration and completion of follow‐up

Intervention mean 12 months, median 13.2 months (range 1 to 26 months) vs control mean 8 months, median 9.2 months (range 1 to 26 months); 182 people completed follow‐up: intervention 90 vs control 92

Types of assessment

No information provided

Notes

Unit of randomisation: individual people. Unit of analyses: separate limbs

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Quote: "Patients were randomised into two groups based upon the odd or even last digit of their Social Security number"

Allocation concealment (selection bias)

High risk

Sequence generation was based upon the last digit of the persons social security number

Blinding (performance bias and detection bias)
Blinding of outcome assessors

Unclear risk

No information provided

Incomplete outcome data (attrition bias)
All outcomes

High risk

182 of 227 people completed follow‐up (intervention 90 vs control 92). Reasons for dropping out were not fitting the eligibility criteria (n = 24), death (n = 13) and unspecified (n = 8)

No ITT analyses were undertaken

Selective reporting (reporting bias)

Low risk

No study protocol available, but the trial report listed the outcomes of interest in both the methods and the results section

Other bias

Unclear risk

Baseline risk for foot ulceration: although described as 'not significant', prior vascular reconstruction higher in control and incidence of foot callus higher in intervention (P < 0.05). No significant differences in foot deformities, neuropathy, gangrene, prior amputation or ulcer and level of distal pulses
Co‐interventions were not described
Adherence: no data provided

Mazzuca 1986

Methods

RCT

Participants

532 people with diabetes mellitus randomised intervention 263 vs control 269

Baseline risk for foot ulceration: no data provided
Study setting: primary care, academic general medicine clinic in the USA

Inclusion criteria: either 2 fasting blood glucose levels > 130 mg/dL or 1 > 150 mg/dL or 2‐hour value > 250 mg/dL, able to perform 2 basic self‐care tasks, no psychiatric or terminal illness, under care of an internal medicine resident, informed consent

Interventions

Intervention group:
Diagnosis of educational needs according to protocol
Patient education in appropriate modules of instruction by nurses and dieticians by group education using lecture, discussion and/or audio‐visual materials, demonstration, return demonstration and feedback, goal setting, and written contract on goals. Content (depending on individual educational needs): understanding diabetes, acute complications, antidiabetic medication, antihypertensive medication, diet and activity, foot care and urine testing
Reinforcement by phone contact 2 and 6 weeks after instruction

Control group:

Usual care. Content: including routine education

Adherence: 139 of 208 (67%) people needing instruction on foot care completed this

Outcomes

Primary outcomes: none reported
Secondary outcomes: level of foot care knowledge

Duration and completion of follow‐up

Median interval between instruction and follow‐up measurement 11.8 to 14.3 months; 275 people completed follow‐up: intervention 135 vs control 140

Types of assessment

Level of foot care knowledge: nurse‐administered patient history following predefined learning objectives

Notes

Knowledge objectives unclear

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No information provided

Allocation concealment (selection bias)

Unclear risk

No information provided

Blinding (performance bias and detection bias)
Blinding of outcome assessors

High risk

Assessments were not conducted by personnel who were blind to subjects' experimental condition

Incomplete outcome data (attrition bias)
All outcomes

High risk

275 of 532 people completed follow‐up (intervention 135 vs control 140). Reasons for dropping out were death (n = 30), physical or psychological incapacitation (n = 43), transfer to a senior staff physician (n = 32), relocation (n = 13), work conflict (n = 24), personal reasons (n = 45), failure to keep appointments (n = 11) and lost contact (n = 58)
No ITT analyses were undertaken

Selective reporting (reporting bias)

Low risk

No study protocol available, but the trial report lists the outcomes of interest in both the methods and the results section

Other bias

High risk

Baseline risk for foot ulceration: no data provided
Co‐interventions were not described
Adherence: 139 of 208 (67%) people needing instruction on foot care completed this

Rettig 1986

Methods

RCT

Participants

471 people with diabetes mellitus randomised intervention 228 vs control 243

Baseline risk for foot ulceration: no data provided
Study setting: community‐based care

Inclusion criteria: identified as diabetic inpatient of participating hospitals (unclear which type of diabetes), age < 65 years (at begin of study), no terminal illness, physician approval

Interventions

Intervention group:
Up to 12 home patient education sessions, provided by nurses, who attended special 4‐day intensive course in diabetes self care. Content: according to judgement of nurse, tailored to patient self management needs, which were defined with 100 short answer and yes/no questions

Control group:

Usual care. Content: not specified

Adherence: no data provided

Outcomes

Primary outcomes: none
Secondary outcomes: foot appearance score, foot care knowledge, behaviour assessment score

Duration and completion of follow‐up

6 months; 373 people completed follow‐up: intervention 180 vs control 193

Types of assessment

Foot appearance assessment: nurse scored a 16‐item checklist
Foot care knowledge assessment: 70 multiple‐choice questions, covering 4 areas of which foot care was 1
Behaviour assessment: skills assessed by nurse

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No information provided

Allocation concealment (selection bias)

Unclear risk

No information provided

Blinding (performance bias and detection bias)
Blinding of outcome assessors

Low risk

The staff nurses, who were the outcome assessors, were not aware of subject assignment at the time of the follow‐up visit

Incomplete outcome data (attrition bias)
All outcomes

High risk

373 of 471 people completed follow‐up (intervention 180 vs control 193). Reasons for dropping out were deaths, violations of the protocol (such as an excessive number of home visits) and unspecified
No ITT analyses were undertaken

Selective reporting (reporting bias)

Low risk

No study protocol available, but the trial report lists the outcomes of interest in both the methods and the results section

Other bias

Unclear risk

Baseline risk for foot ulceration: no data provided
Co‐interventions were not described
Adherence: no data provided

Rönnemaa 1997

Methods

RCT

Participants

530 people with diabetes mellitus randomised, intervention 267 vs control 263Baseline risk for foot ulceration: no data provided

Baseline outcome measures:
Foot care knowledge score: intervention 26.7 (SD 11.4) vs control 26.1 (SD 11.8)
Self‐care behaviour assessment score: intervention 5.4 (SD 2.8) vs control 5.3 (SD 2.6)
Callosities: intervention 18.5% calcaneal region, 54.5% other regions; control 16.8% calcaneal region, 51.3% other regions
Diameter of greatest callosity: intervention calcaneal region (n = 49) 40.5 mm (SD 30.8 mm), other regions (n = 141) 16.6 mm (SD 10.2 mm); control calcaneal region (n = 55) 30.6 mm (SD 28.5 mm), other regions (n = 138) 15.2 mm (SD 9.8 mm)
Podiatrist visit: intervention 12.4% in previous year, 73.4% never before vs control 10.4% in previous year, 76.1% never before
Foot examination by physician in previous year: intervention 36.7% routinely, 9.5% following complaints vs control 46.4% routinely, 12.3% following complaints

Study setting: community‐based care in the vicinity of Turku, Finland

Inclusion criteria: included in the national drug imbursement register for receiving antidiabetic treatment, no obvious need for podiatry, no visit with podiatrist in previous 6 months, age between 10 to 79 years

Interventions

Intervention group:
45 minutes' individual patient education. Content: education on use of proper footwear, daily hygiene, cutting of toenails, use of emollient cream, avoidance of high‐risk situations and foot gymnastics
Podiatric care visits (to 1 of 3 participating podiatrists) of 30 to 60 minutes' duration as necessary. Content: preventive podiatric care as debridement of callus, preparation of insoles, treatment of ingrowing toenails and guidance for foot gymnastics

Control group:

Written information. Content: instructions on foot care

Adherence: intervention mean number of podiatry visits 4.7 in first year. After first and before seventh follow‐up year at least 1 podiatry visit in 82.3% of people in intervention and in 49.7% in control

Outcomes

Primary outcomes: amputation rate, ulcer incidence
Secondary outcomes: callus development, foot care knowledge, behaviour assessment scores

Duration and completion of follow‐up

1 and 7 years; 459 completed 1 year of follow‐up: intervention 233 vs control 226
332 completed 7 years of follow‐up: intervention 169 vs control 163

Types of assessment

Callus diameter in millimetres.
Knowledge score: 19 three‐choice questions of which 1 or 2 correct answers: correct = 1, unknown = 0, incorrect = 1 (total score range 0 to 57)
Behaviour assessment score: range 0 to 12

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Randomisation was performed separately for men and women and for people below and above 20 years of age. Method of randomisation not described

Allocation concealment (selection bias)

Unclear risk

No information provided

Blinding (performance bias and detection bias)
Blinding of outcome assessors

Unclear risk

The outcome assessor was blinded to the baseline characteristics, but no further information on blinding to the group allocation is provided

Incomplete outcome data (attrition bias)
All outcomes

High risk

Follow‐up was completed by only 63% of people in the intervention group and 62% of people in the control group at 7 years
No ITT analysis undertaken

Selective reporting (reporting bias)

Low risk

No study protocol available, but the trial report lists the outcomes of interest in both the methods and the results section

Other bias

High risk

Baseline risk for foot ulceration: no data provided
Adherence: intervention mean number of podiatry visits 4.7 in first year. After first and before seventh follow‐up year at least 1 podiatry visit in 82.3% of people in intervention and in 49.7% in control
Co‐interventions: podiatry care was provided to intervention group people only

BMI = body mass index, CI = confidence interval, HbA1c = glycated haemoglobin, HR = hazard ratio, ITT = intention to treat, PVD = peripheral vascular disease, RA = risk assessment, RCT = randomised controlled trial, RR = risk ratio, SD = standard deviation, SDSCA = Summary of Diabetes Self‐Care Activities.

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Dargis 1999

Not a randomised controlled study design

Davidson 2000

Not a randomised controlled study design and no educational programme that includes patient education aimed at reducing diabetic foot ulcers

De Weerdt 1991

No educational programme that included patient education aimed at reducing diabetic foot ulcers, and no relevant outcomes reported

Donohoe 2000

No educational programme targeted at people that includes patient education aimed at reducing diabetic foot ulcers

Fresenius 2009

Education initially directed at wound healing. Patient education for preventing ulcer recurrence only offered to participants with healed index lesions

Glasgow 1992

No relevant outcomes reported

Litzelman 1993

Foot care education is part of the comprehensive intervention on foot ulceration but not the main contrast with the control

Litzelman 1997

Not a randomised controlled study design

McCabe 1998

Foot care education is not the main contrast with the control

McMurray 2002

Foot care education is not the main contrast with the control

Nesari 2010

Foot care education is not the main contrast with the control

Pieber 1995

Not a randomised controlled study design

Plank 2003

No educational programme targeted at people that includes patient education aimed at reducing diabetic foot ulcers, and education not the main contrast with the control

Reichard 1993

No educational programme that includes patient education aimed at reducing diabetic foot ulcers

Schiel 2004

Foot care education is not the main contrast with the control

Vinicor 1985

No educational programme that includes patient education aimed at reducing diabetic foot ulcers, and no relevant outcomes reported

Ward 1999

Not a randomised controlled study design

Wooldridge 1996

Not a randomised controlled study design

Zhenghua 2011

Only conference abstract. No full‐text article available.

Characteristics of studies awaiting assessment [ordered by study ID]

Gershater 2011

Methods

Participants

Interventions

Outcomes

Notes

The main result is planned to be presented at the Diabetic Foot Meeting in Haag 20‐23 May 2015, and a manuscript is submitted.

Data and analyses

Open in table viewer
Comparison 1. Effects of intensive versus brief education in high risk patient samples

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Foot ulcer incidence (1‐year follow‐up) Show forest plot

1

354

Risk Ratio (M‐H, Fixed, 95% CI)

0.31 [0.14, 0.66]

Analysis 1.1

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 1 Foot ulcer incidence (1‐year follow‐up).

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 1 Foot ulcer incidence (1‐year follow‐up).

2 Amputation Rate (1‐year follow‐up) Show forest plot

1

354

Risk Ratio (M‐H, Fixed, 95% CI)

0.33 [0.15, 0.76]

Analysis 1.2

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 2 Amputation Rate (1‐year follow‐up).

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 2 Amputation Rate (1‐year follow‐up).

3 Foot ulcer incidence (1‐year follow‐up) Show forest plot

1

172

Risk Ratio (M‐H, Random, 95% CI)

1.00 [0.70, 1.44]

Analysis 1.3

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 3 Foot ulcer incidence (1‐year follow‐up).

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 3 Foot ulcer incidence (1‐year follow‐up).

4 Amputation rate (1‐year follow‐up) Show forest plot

1

172

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.41, 2.34]

Analysis 1.4

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 4 Amputation rate (1‐year follow‐up).

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 4 Amputation rate (1‐year follow‐up).

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 1

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 1 Foot ulcer incidence (1‐year follow‐up).
Figuras y tablas -
Analysis 1.1

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 1 Foot ulcer incidence (1‐year follow‐up).

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 2 Amputation Rate (1‐year follow‐up).
Figuras y tablas -
Analysis 1.2

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 2 Amputation Rate (1‐year follow‐up).

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 3 Foot ulcer incidence (1‐year follow‐up).
Figuras y tablas -
Analysis 1.3

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 3 Foot ulcer incidence (1‐year follow‐up).

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 4 Amputation rate (1‐year follow‐up).
Figuras y tablas -
Analysis 1.4

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 4 Amputation rate (1‐year follow‐up).

Table 1. Results from trials

Study ID

Primary outcomes

Secondary outcomes

Barth 1991

No primary outcomes reported

Foot problems requiring treatment:
Significant reduction in intervention after 1 month (P < 0.001), maintained until final follow‐up at 6 months
Reduction was significantly smaller in control than in intervention after 1 month (P < 0.006), but not after 6 months (P = 0.216)

Foot care knowledge:
Significant increase in both groups at 1 month (P < 0.001), but more in intervention than in control (P < 0.001). Changes were maintained until final follow‐up at 6 months

Foot care routine compliance:
Significant increase in intervention after 1 month (P < 0.001), maintained until final follow‐up
Increase was significantly greater in intervention than in control after 1 month (P = 0.012)

Bloomgarden 1987

Ulcer or amputation:
people with no foot lesions at baseline:
intervention 2/83 vs control 2/63

people with callus, nail dystrophy or fungal infection at baseline: intervention 2/37 vs control 3/63

people with an ulcer or amputation at baseline: intervention 6/7 vs control 11/13

Callus, nail dystrophy and fungal infection:
people with no foot lesions at baseline: intervention 31/83 vs control 28/63 (ns)
people with callus, nail dystrophy or fungal infection at baseline: intervention 24/37 vs control 46/63 (ns)
people with an ulcer or amputation at baseline: intervention 1/7 vs control 1/13 (ns)

Behaviour assessment scores:
intervention from 3.4 to 4.3. Control from 3.6 to 4.1 (P = 0.10). Separate data for foot care not provided

Borges 2004

No primary outcomes reported

Patients' self‐reported behaviour assessment scores:
intervention from 4.7 to 5.6 (P < 0.01). RA from 4.8 to 5.2 (P = 0.06). C from 5.1 to 5.4 (P < 0.05)

Observed self‐care behaviour:
4 of 16 items significantly (P < 0.05) more observed in intervention than in control

Foot care knowledge scores:
Increased within the control group, but not in the intervention or RA groups

Cisneros 2010

Ulcer incidence:

people without a history of foot ulceration: intervention 8/21 vs control 8/14 (P = 0.317)

Patient with a history of foot ulceration: intervention 1/8 vs control 5/8 (P = 0.119)

All people: difference between the survival curves of intervention and control (P = 0.362) (HR not reported)

No secondary outcomes reported

Corbett 2003

No primary outcomes reported

Foot care knowledge scores:
intervention from 4.9 to 6.1 vs control from 4.6 to 5.2 (P = 0.03)

Foot care practice scores:
intervention from 4.3 to 5.6 vs control from 4.1 to 4.3 (P = 0.007)

Frank 2003

No primary outcomes reported

Foot care knowledge scores:
Means: intervention 20.98 (SD 2.46) vs control 18.60 (SD 2.93), (P < 0.001)
Mean differences: intervention 2.33 (SD 2.49) vs control 1.10 (SD 2.89), (P = 0.028)

Patients' behaviour assessment:
(mean number of days per week)
Checking feet: intervention 6.33 vs control 5.88 (P = 0.203). Mean differences: intervention 1.13 vs control 1.35 (P = 0.708)
Washing feet: intervention 5.75 vs control 5.94 (P = 0.573). Mean differences: intervention 0.58 vs control 0.52 (P = 0.863)
Applying lotion: intervention 5.96 vs control 4.94 (P = 0.044). Mean differences: intervention 1.42 vs control 0.75 (,P = 0.191)
Wearing shoes and socks: intervention 5.60 vs control 5.42 (P = 0.705). Mean differences: intervention 1.90 vs control 0.50 (P = 0.036)

Kruger 1992

No primary outcomes reported

Foot status:
No significant difference.

Foot care knowledge scores:
intervention from 9.1 to 10.0 vs control from 8.66 to 9.86, statistically significant increase in control group (P = 0.02), but not in the intervention group (P = 0.078)

Behaviour assessment:
Daily foot inspection: intervention from 52.5% to 66.7% vs control from 34.8% to 66.7% (ns)
Daily foot washing: intervention from 82.6% to 86.7% vs control from 74.1% to 73.3% (statistically significant increase in intervention group)
Use of pumice stones for corns: intervention from 4.3% to 26.7% vs control from 3.7% to 26.7% (ns)
Trimming toenails regularly: intervention from 34.8% to 80.0% vs control from 66.7% to 66.7% (statistically significant increase in intervention group)
Improvement in keeping toenails shorter: intervention from 30.4% to 80.0% vs control from 66.7% to 86.7% (ns)

Lincoln 2008

Ulcer incidence:
After 6 months: intervention 26 vs control 18, RR 1.41 (95% CI 0.84 to 2.38)
After 12 months: intervention 36 vs control 35, RR 1.00 (95% CI 0.70 to 1.44)

Amputation rate:
After 6 months: intervention 3 vs control 0, RR not estimable
After 12 months: intervention 9 vs control 9, RR 0.98 (95% CI 0.41 to 2.34)

Behaviour assessment scores:
intervention 42.0 vs control 38.7 (P = 0.03)

Malone 1989

Ulcer incidence:
intervention 8 vs control 26; significantly lower in intervention group (P ≤ 0.005)

Amputation rate:
intervention 7 vs control 21; significantly lower in intervention group (P < 0.025)

No secondary outcomes reported

Mazzuca 1986

No primary outcomes reported

Foot care knowledge scores:
No significant difference

Rettig 1986

No primary outcomes reported

Foot appearance scores (mean ±standard error):
intervention 70.2 ± 0.7 vs control 68.8 ±0.7 (ns)

Foot care knowledge scores:
intervention 62.2 ±1.7 vs control 53.1 ± 1.8 (P = 0.001). Significant increase in intervention group

Foot care skills scores:
intervention 71.8 ±2.0 vs control 68.9 ± 1.8 (ns)

Rönnemaa 1997

Amputation:
1‐year follow‐up: intervention 0 vs control 0

7‐year follow‐up: intervention 1 vs control 0

Foot ulceration:
1‐year follow‐up: intervention 1 vs control 0

7‐year follow‐up: intervention 1 vs control 1

Callus development:
1‐year follow‐up:

Calcaneal region:

  • presence of callus: intervention from 18.5% to 12.0% vs control from 16.8% to 15.5% (ns)

  • mean diameter: intervention from 40.5 mm (SD 30.8 mm) to 25.5 mm (SD 28.8 mm) vs control from 30.6 mm (SD 28.5 mm) to 28.3 mm (SD 26.8 mm); statistically significant decrease in area of callosities at calcaneal region in intervention group (P = 0.065)

Other regions:

  • presence of callus: intervention from 54.5% to 39.5% vs control from 51.3% to 48.2%; significant decrease in callosities in intervention group (P < 0.009)

  • mean diameter: intervention from 16.6 mm (SD 10.2 mm) to 11.4 mm (SD 10.3 mm) vs control from 15.2 mm (SD 9.8 mm) to 14.4 mm (SD 9.9 mm); statistically significant decrease in area of callosities in intervention group (P < 0.001)

7‐year follow‐up:

Calcaneal region:

  • presence of callus: intervention 12.4% vs control 12.9%, RR 0.96 (95% CI 0.55 to 1.70)

Other regions:

  • presence of callus: intervention 23.1% vs control 30.1%, RR 0.77 (95% CI 0.53 to 1.01)

Foot care knowledge scores:
1‐year follow‐up:

  • intervention from 26.7 (SD 11.4) to 32.1 (SD 10.8) vs control from 26.1 (SD 11.8) to 29.2 (SD 12.6); statistically significant increase in intervention group (P = 0.004)

7‐year follow‐up:

  • mean scores: intervention 33.6 (SD 10.5) vs control 33.0 (SD 11.1) (ns)

Patients' behaviour assessment scores:
1‐year follow‐up:

  • mean scores: intervention from 5.4 (SD 2.8) to 7.0 (SD 3.2) vs control 5.3 (SD 2.6) to 6.0 (SD 2.5); statistically significant increase in intervention group

7‐year follow‐up:

  • mean scores: intervention 6.6 (SD 2.7) vs control 6.4 (SD 2.7) (ns)

Abbreviations: CI = confidence interval, ns = no statistical significance, RA = group that received risk assessment only, RR = risk ratio, SD = standard deviation.

Figuras y tablas -
Table 1. Results from trials
Comparison 1. Effects of intensive versus brief education in high risk patient samples

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Foot ulcer incidence (1‐year follow‐up) Show forest plot

1

354

Risk Ratio (M‐H, Fixed, 95% CI)

0.31 [0.14, 0.66]

2 Amputation Rate (1‐year follow‐up) Show forest plot

1

354

Risk Ratio (M‐H, Fixed, 95% CI)

0.33 [0.15, 0.76]

3 Foot ulcer incidence (1‐year follow‐up) Show forest plot

1

172

Risk Ratio (M‐H, Random, 95% CI)

1.00 [0.70, 1.44]

4 Amputation rate (1‐year follow‐up) Show forest plot

1

172

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.41, 2.34]

Figuras y tablas -
Comparison 1. Effects of intensive versus brief education in high risk patient samples