IJTR · 2025
A multicentre, prospective, randomized controlled modified platform trial evaluating PURION processed lyophilized human amnion/chorion membrane and standard of care versus standard of care alone in the treatment of non-healing diabetic foot ulcers
Serena, T.E., Tramelli, B., King, E., & Maloumi, S.
International Journal of Tissue Repair (IJTR), protocol
In brief
This protocol describes a multicenter, prospective randomized trial evaluating two PURION-processed human amnion/chorion membrane products (EPIEFFECT and EPIXPRESS), each used with standard care, against standard care alone in patients with non-healing diabetic foot ulcers. The study plans to enroll approximately 170 patients and will evaluate complete wound closure within 12 weeks, along with secondary outcomes including time to closure, wound area reduction, adverse events, and quality of life. No trial results are reported in this protocol.
Sponsored by MiMedx. The SerenaGroup authors are involved in running the trial.
Plain-language summary by SerenaGroup. See the full text for complete methods and results.
Abstract
Aims: To evaluate the efficacy of PURION-processed lyophilized human amnion/chorion membrane (ppLHACM) products— EPIEFFECT and EPIXPRESS—in conjunction with standard of care (SOC) compared to SOC alone in the treatment of nonhealing diabetic foot ulcers (DFUs), using a novel modified platform trial design. Methods: This is a multicentre, prospective, randomized controlled trial utilizing a modified platform design. Patients with non-healing DFUs will be randomized into three groups: SOC alone or SOC plus one of two ppLHACM products. The primary endpoint is complete wound closure within 12 weeks. Secondary outcomes include time to closure, percentage area reduction, adverse events, and quality of life measured by the Forgotten Wound Score and Wound Quality of Life questionnaire. Exploratory objectives include assessment of offloading compliance, chronic inhibitory bacterial load, host protease activity, and continuous glucose monitoring data. Results: The results will be reported following trial completion. Once 50% of the target sample size has been enrolled and followed, an interim analysis is planned. Conclusion: This trial is expected to provide high-quality efficacy data on ppLHACM products and contribute to evidencebased practice in DFU management. The novel modified platform design offers a flexible and efficient approach to evaluating multiple interventions within a single clinical trial.
Keywords
Cellular acellular and matrix-like productsclinical trial protocoldiabetic foot ulcerskin substitutes
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