Processed amnion/chorion allograft and Excellion-processed amnion allograft characterization and trial design aligned with AHRQ standards for chronic lower extremity ulcers
DOI:
https://doi.org/10.63676/km40xx10Keywords:
Wound Healing, Diabetic foot ulcer, Wound epithelialization, Leg ulcerAbstract
Aims: This study protocol is designed to evaluate whether Excellion-processed amnion/chorion allograft (EPACA) and amniotic allograft (EPAA) accelerate closure and improve quality of life compared with standard of care (SOC) for chronic diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs), respectively.
Methods: This randomized, controlled, multicenter trial enrolls adults with DFUs (>1–25 cm²) or VLUs (>1–50 cm²) unresponsive to SOC after a 2-week run-in (<30% wound size reduction). Participants are randomized 1:1 to either EPACA vs SOC for DFUs or EPAA vs SOC for VLUs. The primary endpoint is complete epithelialization within 12 weeks for DFUs and 16 weeks for VLUs. Secondary endpoints include time to healing and quality of life (SF-36).
Results: Independent laboratory analysis demonstrated consistent retention of multiple regulatory proteins across Excellion-processed amnion and amnion/chorion allografts, with low inter-batch variability, supporting preservation of biologically relevant tissue components. These characterization data were generated within a rigorously designed multicenter randomized controlled trial incorporating Agency for Healthcare Research and Quality-recommended methodological features, including a run-in period, standardized endpoints, objective digital wound assessment, and extended follow-up.
Conclusions: The findings establish biologic plausibility and compositional consistency of EPACA and EPAA while demonstrating feasibility of their evaluation within a robust clinical trial framework. Ongoing enrollment and final analyses will assess long-term wound closure durability and recurrence to further define clinical value.
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