Critical appraisal of the quality of evidence addressing the diagnosis, prognosis, and management of peripheral artery disease in patients with diabetic foot ulceration

Aims: There is a paucity of robust evidence on prevention and management of diabetic foot ulcers (DFUs) to inform treatment. This study appraises the current quality of the evidence addressing diagnosis, prognosis, and management of peripheral artery disease (PAD) in patients with DFUs using a newly devised 21 point scoring (TOPS) disease specific research appraisal tool published by the International Working Group on the Diabetic Foot (IWGDF) and European Wound Management Association. Methods: The 2015 IWGDF guidance on diagnosis, prognosis, and management of PAD in patients with DFUs was used to identify studies pertaining to prevention and management. Two reviewers assessed these articles against TOPS, which examines study design, conduct, and outcome reporting. Results: The overall median score was 8 (3–12/21). The median design total score was 2 (0–4/11). The median conduct total score was 2 (1–4/6). The median outcomes total score was 3 (1–4/4). There was improvement with time in overall total (Spearman Rho 0.39, p =.0005), design total (0.35, p =.0023), and outcomes total (0.35, p =.0002), but not conduct total (−0.03, p =.8132) scores. Conclusions: Although this analysis revealed an improvement over time in the overall calibre of studies, the present quality remains poor on which to inform the diagnosis, management, and prognosis of patients with PAD and diabetic foot ulceration.