RecruitingNot ApplicableNCT06600724

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


Sponsor

MiMedx Group, Inc.

Enrollment

170 participants

Start Date

Aug 27, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a biological membrane graft called PpLHACM, in addition to standard wound care, can help heal stubborn diabetic foot ulcers (open sores on the foot that don't heal) that have not responded to standard treatment alone. **You may be eligible if...** - You are 18 or older - You have type 1 or type 2 diabetes - You have a foot ulcer that is between 0.7 and 5 square centimeters in size - The ulcer has been present between 4 weeks and 12 months despite standard wound care - The ulcer is located below the ankle - The ulcer does not involve exposed bone or tendon - Blood flow to the affected leg is adequate (confirmed by vascular testing) **You may NOT be eligible if...** - The ulcer is infected or has exposed bone/tendon - You have significant circulation problems in the affected leg - You have multiple ulcers very close together (less than 2 cm apart) - You have other conditions that would interfere with wound healing Talk to your doctor to see if this trial is right for you.

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

OTHERStandard of Care

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.

OTHEREPIEFFECT

Participants will receive weekly applications of EPIEFFECT and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first

OTHEREPIXPRESS

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)

SerenaGroup - Monroeville

Monroeville, Pennsylvania, United States

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NCT06600724


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