IJTR · 2025
Evaluation of single layer amniotic membrane in the management of nonhealing diabetic foot ulcers
Serena, T.E., Tramelli, B., King, E., Shi, D., Bohn, G., & Breisinger, R.
International Journal of Tissue Repair (IJTR), interim analysis, CAMPX trial
In brief
This interim analysis of CAMPX, a randomized controlled multicenter trial, compared a single-layer amniotic membrane (SLAM) plus standard of care with standard of care alone for nonhealing diabetic foot ulcers over 12 weeks. In the intent-to-treat population, complete wound closure occurred in 13.1% of patients receiving SLAM plus standard care compared with 8.8% receiving standard care alone; in the per-protocol population, closure rates were 20% and 16%, respectively. The differences in closure rates were not statistically significant at this interim analysis, although the authors reported numerically higher closure rates and greater wound area reduction with SLAM. Enrollment is continuing toward the planned sample size.
SerenaGroup ran this trial for Applied Biologics.
Plain-language summary by SerenaGroup. See the full text for complete methods and results.
Abstract
Background: Diabetic foot ulcers (DFUs) represent a chronic and debilitating complication of diabetes, contributing substantially to patient morbidity, mortality, and economic burden. Despite advances in clinical management, outcomes with the current standard of care (SOC) remain suboptimal, with many ulcers failing to achieve complete closure. These limitations reinforce the need for innovative, cost-effective solutions that promote wound closure. Methods: This randomized controlled multicenter clinical trial evaluated the efficacy of single layer amniotic membrane (SLAM) plus SOC versus SOC alone in achieving complete closure of nonhealing DFUs over 12 weeks. The primary endpoint was complete wound closure, defined as 100% re-epithelialization without drainage for two consecutive weeks, confirmed by blinded independent review. Results: In Intent-To-Treat (ITT), the SLAM + SOC arm achieved a 13.1% closure rate versus 8.8% with SOC alone, with findings consistent in the Per-Protocol (PP) population. Additionally, the percent area reduction (PAR) from TV-1 to TV13 measured weekly with digital photographic planimetry and physical examination were analyzed. For ITT, SLAM + SOC outperformed SOC on both average and median wound‐area reduction. Conclusion: The interim analysis demonstrated that wounds managed with SLAM products trended toward superiority over those managed with SOC.
Keywords
Cellular acellular and matrix-like productsdiabetic foot ulcerinterim analysischronic woundstissue regenerationclinical trial design
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