Background: The purpose of this study was to evaluate whether or not standard of care treatment of diabetic foot ulcers has improved over the past 20 years as measured by the percentage of ulcers healed within set periods of time. Previously reported percentages of wound healing were 24% at 12 weeks and 31% at 20 weeks.

Methods: A meta-analysis was performed to review the control groups of randomized clinical trials in the treatment of diabetic foot ulcers. The mean percentage of ulcers healed at defined end points were then compared to percentages of ulcers healed at corresponding end points reported 20 years ago. A literature search was performed to identify articles published before December 30, 2019, to identify randomized controlled clinical trials that included human subjects with diabetic foot ulcers. The control arm was required to include wound debridement, dressing changes, and offloading.

Results: The literature search yielded 16 randomized clinical trials that fit the selection criteria to be included in the meta-analysis. Analysis of the percentage of wounds healed with standard of care therapy alone yielded the following results: 6 weeks (14.9% ± 13.0%), 12 weeks (33.4% ± 18.2%), 20 weeks (43% ± 0%).

Conclusions: The results of this meta-analysis of the available evidence suggest that the percentage of diabetic foot ulcers healed with standard of care therapies alone have improved over the past 20 years. However, the percentage of ulcers healed at each of these endpoints remains low and demonstrates continued challenges in healing diabetic foot ulcers.


V.E. Parks: None. P. Crisologo: None. L.A. Lavery: Advisory Panel; Self; Acelity, Bayer AG. Consultant; Self; Boehringer Ingelheim International GmbH. Research Support; Self; AstraZeneca, Cardinal Health, EO2 Concepts, Integra LifeSciences, MedImmune, Smith & Nephew. J. Banks: None. M.D. Liette: None. L. Johnson: None.

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