Background: Diabetic foot ulcers are complex and create a heavy financial burden to the health system. The purpose of this systematic review and meta-analysis is to assess the clinical effectiveness and safety of human amniotic membrane tissue products in diabetic foot ulcerations.
Methods: A meta-analysis was performed to evaluate the clinical effectiveness of the use of amnion tissue products verses the standard of care in the management of diabetic foot ulcers. A literature search of PubMed/Medline, Cochrane Library, and ClinicalTrials.gov for articles published before December 30, 2019 was performed to identify randomized controlled clinical trials that included human subjects with diabetic foot ulcers treated with amnion tissue products.
Results: The literature search revealed ten randomized clinical trials that fit the selection criteria to be included in the meta analysis. Analysis of the percent of wounds healed yielded the following results: 4 weeks (treatment group 64.2%, SOC 18.8%), 6 weeks (treatment group 60.9%, SOC 60.7%), 12 weeks (treatment group 70.8%, SOC 32.4%) with P <0.01. There was no significant difference in mean number of adverse events between groups with a p=0.71.
Conclusions: The results of this meta-analysis of the available evidence suggest that the application of amniotic tissue products in diabetic foot ulcerations significantly increases the percent of diabetic foot ulcers healed as compared to stand of care alone.
V.E. Parks: None. J. Banks: None. L. Johnson: None. M.D. Liette: 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.