Efficacy of a Polylactic Acid Matrix for the Closure of Wagner Grade 1 and 2 Diabetic Foot Ulcers: A Single-center, Prospective Randomized Trial

Abstract

Introduction. CAMPs are used for treating refractory DFUs where other treatments have failed. PLA is a CAMP that has demonstrated effectiveness in promoting healing in burns and acute wounds. Objective. A single-center, prospective, randomized controlled trial comparing PLA-guided closure matrices versus collagen dressings was conducted to assess healing of Wagner grades 1 and 2 DFUs. Materials and Methods. A total of 30 participants were randomized to receive weekly debridement, wound care, and DFU offloading plus either PLA or collagen CAMPs. The primary outcome was the time to achieve full healing, and the secondary outcome was the proportion of ulcers healed at 12 weeks. Results. The median time to achieve full healing was 9.3 ± 2.9 weeks in the PLA group versus 14.8 ± 8.1 weeks in the collagen group (P = .021), representing a 44% reduction in the time to heal. Furthermore, by 12 weeks, 80% of the PLA-treated ulcers were healed compared to only 33% in the collagen group (P = .025). Conclusion. The results of this study show PLA matrices induce a potent healing response that leads to reduced healing time and an increased OR for achieving healing by 12 weeks.