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
DOI:
https://doi.org/10.63676/ctkc9r79Keywords:
Processed Lyophilized Human Amnion/Chorion Membrane (ppLHACM), Cellular, acellular, and matrix-like products , skin substitutes, Clinical trial protocol, Foot ulcer, diabeticAbstract
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 non-healing 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 evidence-based practice in DFU management. The novel modified platform design offers a flexible and efficient approach to evaluating multiple interventions within a single clinical trial.
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Data is available from the corresponding author upon reasonable request.
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