Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs
A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating PURION Processed Lyophilized Human Amnion/Chorion Membrane (ppLHACM) and Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers
MiMedx Group, Inc.
170 participants
Aug 27, 2024
INTERVENTIONAL
Conditions
Summary
This study will evaluate two human amnion/chorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of EPIEFFECT and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
Participants will receive weekly applications of EPIXPRESS and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
Locations(1)
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NCT06600724