Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: a systematic review

Abstract

The management of diabetic foot ulcers (DFU) remains a challenge, and there is continuing uncertainty concerning optimal approaches to wound healing. The International Working Group of the Diabetic Foot (IWGDF) working group on wound healing has previously published systematic reviews of the evidence in 2008, 2012 and 2016 to inform protocols for routine care and to highlight areas which should be considered for further study. The working group has now updated this review by considering papers on the interventions to improve the healing of DFU's published between June 2014 and August 2018. Methodological quality of selected studies was independently assessed by a minimum of two reviewers using the recently published 21‐point questionnaire as recommended by IWGDF/European Wound Management Association, as well as the previously incorporated Scottish Intercollegiate Guidelines Network criteria. Of the 2275 papers identified, 97 were finally selected for grading following full text review. Overall, there has been an improvement in study design and a significant rise in the number of published studies. While previous systematic reviews did not find any evidence to justify the use of newer therapies, except for negative pressure wound therapy in post‐surgical wounds, in this review we found additional evidence to support some interventions including a sucrose‐octasulfate dressing, the combined leucocyte, fibrin and platelet patch as well as topical application of some placental membrane products, all when used in addition to usual best care. Nonetheless, the assessment and comparison of published trials remains difficult with marked clinical heterogeneity between studies: in patient selection, study duration, standard of usual care provision and the timing and description of the clinical endpoints.

Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update)

“…For each assessable outcome we graded the quality of evidence based on the risk of bias of included studies, effect sizes, presence of inconsistency, and evidence of publication bias (the latter where appropriate). We then rated the quality of evidence as “high,” “moderate,” or “low.” The systematic review supporting this guideline is published separately …”

“…The systematic review supporting this guideline is published separately. 4 Third, we formulated recommendations to address each clinical question. We aimed to be clear, specific, and unambiguous on what we recommend, for which persons, and under what circumstances.…”

“…We aimed to be clear, specific, and unambiguous on what we recommend, for which persons, and under what circumstances. Using the GRADE system, we provided the rationale for how we arrived at each recommendation based on the evidence from our systematic review (4), expert opinion where evidence was not available, and a careful weighing of the benefits and harms, patient preferences, and financial costs (resource utilization) related to the intervention or diagnostic method. 2,3 On the basis of these factors, we graded the strength of each recommendation as "strong" or "weak," and for or against a particular intervention or diagnostic method.…”

Ultrasound Devices to Treat Chronic Wounds: The Current Level of Evidence

“…55 In the recently published systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes, the International Working Group on Diabetic Foot (IWGDF) concluded that apart from sharp debridement, there was inadequate evidence to establish the superiority of one debridement over another. 60 At present, the IWGDF has not recommended the use of ultrasound-based technology for debridement nor in DFU healing given the paucity of evidence around clinical effectiveness. 61 The everyday role of ultrasound debridement technology will, therefore, be in situations where other debridement methods, such as sharp debridement, may cause inordinate pain or in which are resistant to conventional debridement techniques.…”

Comment on Löndahl. Number Eight in the Service of Diabetic Foot Ulcer Healing. Diabetes Care 2020;43:515–517

“…First, we do agree that the results of recent hyperbaric oxygen therapy (HBOT) trials are inconsistent and generally fail to provide robust evidence to support the adjunctive use of HBOT for DFUs ( 3 – 5 ). Much of the failure to provide consistent results is due to study design deficiencies; heterogeneity in study populations, inclusion criteria, and outcome measures (DFU healing vs. amputation); lack of sham controls; and loss of subjects because of adverse events and early terminations ( 6 , 7 ). Furthermore, intention-to-treat (ITT) analyses of all enrolled study populations has not been uniformly reported ( 3 ).…”