A renaissance in diabetic foot care: new evidence-based treatments

Abstract

Unhealed diabetic foot ulcers can result in up to 84% of lower extremity amputations. 1 Pecoraro R Reiber G Burgess E Pathways to diabetic limb amputation: basis for prevention. Diabetes Care. 1990; 13: 513-521 Crossref PubMed Scopus (1230) Google Scholar , 2 Larsson J Apelqvist J Agardh CD Stenström A Decreasing incidence of major amputation in diabetic patients: a consequence of a multidisciplinary foot care team approach?. Diabet Med. 1995; 12: 770-776 Crossref PubMed Scopus (315) Google Scholar It is thus important that ulcers are healed quickly. However, there has been a scarcity of evidence-based topical therapy to accelerate the healing of diabetic foot ulcers and this drought has led to a call for well-designed clinical trials. 3 Jeffcoate WJ Bus SA Game FL Hinchliffe RJ Price PE Schaper NC International Working Group on the Diabetic Foot and the European Wound Management AssociationReporting standards of studies and papers on the prevention and management of foot ulcers in diabetes: required details and markers of good quality. Lancet Diabetes Endocrinol. 2016; 4: 781-788 Summary Full Text Full Text PDF PubMed Scopus (124) Google Scholar Over the past year, there has been a renaissance in diabetic foot care and three relatively robust trials on foot ulcers have been published. The first (the Explorer study 4 Edmonds M Lazaro-Martinez JL Alfayate-Garcia JM et al. Sucrose octasulfatedressing versus control dressing in patients with neuroischaemic diabetic foot ulcers (Explorer): an international, multicentre, double-blind, randomised, controlled trial. Lancet Diabetes Endocrinol. 2018; 6: 186-196 Summary Full Text Full Text PDF PubMed Scopus (117) Google Scholar ) reported the benefit of sucrose octasulphate dressing and the second (the ProNOx1 study 5 Edmonds ME Bodansky HJ Boulton AJ et al. Multicenter, randomized controlled, observer-blinded study of a nitric oxide generating treatment in foot ulcers of patients with diabetes – ProNOx1 study. Wound Repair Regen. 2018; (published online April 4.)DOI:10.1111/wrr.12630 Crossref Scopus (25) Google Scholar ) reported the positive outcome of a nitric oxide generating device. The third study (LeucoPatch 6 Game F Jeffcoate W Tarnow L et al. LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-blinded, randomised controlled trial. Lancet Diabetes Endocrinol. 2018; (published online September 7.)http://dx.doi.org/10.1016/S2213-8587(18)30240-7 Summary Full Text Full Text PDF PubMed Scopus (66) Google Scholar ) reported the benefit of a multi-layered patch comprising autologous leucocytes, platelets, and fibrin, which releases cytokines and growth factors involved in tissue repair, 7 Game FL Apelqvist J Attinger C et al. Effectiveness of interventions to enhance healing of chronic ulcers of the foot in diabetes: a systematic review. Diabetes Metab Res Rev. 2016; 32: 154-168 Crossref PubMed Scopus (121) Google Scholar in a multinational, observer-blinded, randomised, controlled trial now published in The Lancet Diabetes & Endocrinology by Frances Game and colleagues. 6 Game F Jeffcoate W Tarnow L et al. LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-blinded, randomised controlled trial. Lancet Diabetes Endocrinol. 2018; (published online September 7.)http://dx.doi.org/10.1016/S2213-8587(18)30240-7 Summary Full Text Full Text PDF PubMed Scopus (66) Google Scholar The trial recruited people with hard-to-heal ulcers, which were defined as ulcers that had less than a 50% reduction of area in response to standard care during a 4-week run-in period. 34% of these ulcers healed within 20 weeks in the intervention group (together with standard care) compared with 22% in patients undergoing standard care alone (odds ratio 1·58, 96% CI 1·04–2·40; p=0·0235). LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked, randomised controlled trialThe use of LeucoPatch is associated with significant enhancement of healing of hard-to-heal foot ulcers in people with diabetes. Full-Text PDF