Preventing foot ulceration in diabetes: systematic review and meta-analyses of RCT data

Fay Crawford (Lead / Corresponding author), Donald J. Nicolson, Aparna E. Amanna, Angela Martin, Saket Gupta, Graham P. Leese, Robert Heggie, Francesca M. Chappell, Heather H. McIntosh

Research output: Contribution to journalReview article

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Abstract

Aims/hypothesis: Foot ulceration is a serious complication for people with diabetes that results in high levels of morbidity for individuals and significant costs for health and social care systems. Nineteen systematic reviews of preventative interventions have been published, but none provides a reliable numerical summary of treatment effects. The aim of this study was to systematically review the evidence from RCTs and, where possible, conduct meta-analyses to make the best possible use of the currently available data.

Methods: We conducted a systematic review and meta-analysis of RCTs of preventative interventions for foot ulceration. OVID MEDLINE and EMBASE were searched to February 2019 and the Cochrane Central Register of Controlled Trials to October 2018. RCTs of interventions to prevent foot ulcers in people with diabetes who were free from foot ulceration at trial entry were included. Two independent reviewers read the full-text articles and extracted data. The quality of trial reporting was assessed using the Cochrane Risk of Bias tool. The primary outcome of foot ulceration was summarised using pooled relative risks in meta-analyses.

Results: Twenty-two RCTs of eight interventions were eligible for analysis. One trial of digital silicone devices (RR 0.07 [95% CI 0.01, 0.55]) and meta-analyses of dermal infrared thermometry (RR 0.41 [95% CI 0.19, 0.86]), complex interventions (RR 0.59 [95% CI 0.38, 0.90], and custom-made footwear and offloading insoles (RR 0.53 [95% CI 0.33, 0.85]) showed beneficial effects for these interventions.

Conclusions/interpretation: Four interventions were identified as being effective in preventing foot ulcers in people with diabetes, but uncertainty remains about what works and who is most likely to benefit.

Original languageEnglish
Pages (from-to)49-64
Number of pages16
JournalDiabetologia
Volume63
Issue number1
Early online date27 Nov 2019
DOIs
Publication statusPublished - Jan 2020

Fingerprint

Meta-Analysis
Foot
Foot Ulcer
Thermometry
Silicones
MEDLINE
Uncertainty
Morbidity
Delivery of Health Care
Costs and Cost Analysis
Equipment and Supplies
Skin

Keywords

  • Diabetes
  • Evidence-based healthcare
  • Foot ulcer
  • Meta-analysis
  • Prevention
  • Systematic review

Cite this

Crawford, F., Nicolson, D. J., Amanna, A. E., Martin, A., Gupta, S., Leese, G. P., ... McIntosh, H. H. (2020). Preventing foot ulceration in diabetes: systematic review and meta-analyses of RCT data. Diabetologia, 63(1), 49-64. https://doi.org/10.1007/s00125-019-05020-7
Crawford, Fay ; Nicolson, Donald J. ; Amanna, Aparna E. ; Martin, Angela ; Gupta, Saket ; Leese, Graham P. ; Heggie, Robert ; Chappell, Francesca M. ; McIntosh, Heather H. / Preventing foot ulceration in diabetes : systematic review and meta-analyses of RCT data. In: Diabetologia. 2020 ; Vol. 63, No. 1. pp. 49-64.
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abstract = "Aims/hypothesis: Foot ulceration is a serious complication for people with diabetes that results in high levels of morbidity for individuals and significant costs for health and social care systems. Nineteen systematic reviews of preventative interventions have been published, but none provides a reliable numerical summary of treatment effects. The aim of this study was to systematically review the evidence from RCTs and, where possible, conduct meta-analyses to make the best possible use of the currently available data.Methods: We conducted a systematic review and meta-analysis of RCTs of preventative interventions for foot ulceration. OVID MEDLINE and EMBASE were searched to February 2019 and the Cochrane Central Register of Controlled Trials to October 2018. RCTs of interventions to prevent foot ulcers in people with diabetes who were free from foot ulceration at trial entry were included. Two independent reviewers read the full-text articles and extracted data. The quality of trial reporting was assessed using the Cochrane Risk of Bias tool. The primary outcome of foot ulceration was summarised using pooled relative risks in meta-analyses.Results: Twenty-two RCTs of eight interventions were eligible for analysis. One trial of digital silicone devices (RR 0.07 [95{\%} CI 0.01, 0.55]) and meta-analyses of dermal infrared thermometry (RR 0.41 [95{\%} CI 0.19, 0.86]), complex interventions (RR 0.59 [95{\%} CI 0.38, 0.90], and custom-made footwear and offloading insoles (RR 0.53 [95{\%} CI 0.33, 0.85]) showed beneficial effects for these interventions.Conclusions/interpretation: Four interventions were identified as being effective in preventing foot ulcers in people with diabetes, but uncertainty remains about what works and who is most likely to benefit.",
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author = "Fay Crawford and Nicolson, {Donald J.} and Amanna, {Aparna E.} and Angela Martin and Saket Gupta and Leese, {Graham P.} and Robert Heggie and Chappell, {Francesca M.} and McIntosh, {Heather H.}",
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Crawford, F, Nicolson, DJ, Amanna, AE, Martin, A, Gupta, S, Leese, GP, Heggie, R, Chappell, FM & McIntosh, HH 2020, 'Preventing foot ulceration in diabetes: systematic review and meta-analyses of RCT data', Diabetologia, vol. 63, no. 1, pp. 49-64. https://doi.org/10.1007/s00125-019-05020-7

Preventing foot ulceration in diabetes : systematic review and meta-analyses of RCT data. / Crawford, Fay (Lead / Corresponding author); Nicolson, Donald J.; Amanna, Aparna E.; Martin, Angela; Gupta, Saket; Leese, Graham P.; Heggie, Robert; Chappell, Francesca M.; McIntosh, Heather H.

In: Diabetologia, Vol. 63, No. 1, 01.2020, p. 49-64.

Research output: Contribution to journalReview article

TY - JOUR

T1 - Preventing foot ulceration in diabetes

T2 - systematic review and meta-analyses of RCT data

AU - Crawford, Fay

AU - Nicolson, Donald J.

AU - Amanna, Aparna E.

AU - Martin, Angela

AU - Gupta, Saket

AU - Leese, Graham P.

AU - Heggie, Robert

AU - Chappell, Francesca M.

AU - McIntosh, Heather H.

N1 - Funding: NIHR HTA (HTA 15/171/01)

PY - 2020/1

Y1 - 2020/1

N2 - Aims/hypothesis: Foot ulceration is a serious complication for people with diabetes that results in high levels of morbidity for individuals and significant costs for health and social care systems. Nineteen systematic reviews of preventative interventions have been published, but none provides a reliable numerical summary of treatment effects. The aim of this study was to systematically review the evidence from RCTs and, where possible, conduct meta-analyses to make the best possible use of the currently available data.Methods: We conducted a systematic review and meta-analysis of RCTs of preventative interventions for foot ulceration. OVID MEDLINE and EMBASE were searched to February 2019 and the Cochrane Central Register of Controlled Trials to October 2018. RCTs of interventions to prevent foot ulcers in people with diabetes who were free from foot ulceration at trial entry were included. Two independent reviewers read the full-text articles and extracted data. The quality of trial reporting was assessed using the Cochrane Risk of Bias tool. The primary outcome of foot ulceration was summarised using pooled relative risks in meta-analyses.Results: Twenty-two RCTs of eight interventions were eligible for analysis. One trial of digital silicone devices (RR 0.07 [95% CI 0.01, 0.55]) and meta-analyses of dermal infrared thermometry (RR 0.41 [95% CI 0.19, 0.86]), complex interventions (RR 0.59 [95% CI 0.38, 0.90], and custom-made footwear and offloading insoles (RR 0.53 [95% CI 0.33, 0.85]) showed beneficial effects for these interventions.Conclusions/interpretation: Four interventions were identified as being effective in preventing foot ulcers in people with diabetes, but uncertainty remains about what works and who is most likely to benefit.

AB - Aims/hypothesis: Foot ulceration is a serious complication for people with diabetes that results in high levels of morbidity for individuals and significant costs for health and social care systems. Nineteen systematic reviews of preventative interventions have been published, but none provides a reliable numerical summary of treatment effects. The aim of this study was to systematically review the evidence from RCTs and, where possible, conduct meta-analyses to make the best possible use of the currently available data.Methods: We conducted a systematic review and meta-analysis of RCTs of preventative interventions for foot ulceration. OVID MEDLINE and EMBASE were searched to February 2019 and the Cochrane Central Register of Controlled Trials to October 2018. RCTs of interventions to prevent foot ulcers in people with diabetes who were free from foot ulceration at trial entry were included. Two independent reviewers read the full-text articles and extracted data. The quality of trial reporting was assessed using the Cochrane Risk of Bias tool. The primary outcome of foot ulceration was summarised using pooled relative risks in meta-analyses.Results: Twenty-two RCTs of eight interventions were eligible for analysis. One trial of digital silicone devices (RR 0.07 [95% CI 0.01, 0.55]) and meta-analyses of dermal infrared thermometry (RR 0.41 [95% CI 0.19, 0.86]), complex interventions (RR 0.59 [95% CI 0.38, 0.90], and custom-made footwear and offloading insoles (RR 0.53 [95% CI 0.33, 0.85]) showed beneficial effects for these interventions.Conclusions/interpretation: Four interventions were identified as being effective in preventing foot ulcers in people with diabetes, but uncertainty remains about what works and who is most likely to benefit.

KW - Diabetes

KW - Evidence-based healthcare

KW - Foot ulcer

KW - Meta-analysis

KW - Prevention

KW - Systematic review

U2 - 10.1007/s00125-019-05020-7

DO - 10.1007/s00125-019-05020-7

M3 - Review article

C2 - 31773194

VL - 63

SP - 49

EP - 64

JO - Diabetologia

JF - Diabetologia

SN - 0012-186X

IS - 1

ER -