Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating Placental Derived Allografts and Standard of Care in the Treatment of Nonhealing Diabetic Foot Ulcers Using Matched Controls
Sequence LifeScience, Inc.
350 participants
Jul 11, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.
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
Participants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of AmnioDefend™ FT Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Palisade™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Enclose™ TL Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Sentry™ SL Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Shelter™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Locations(1)
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NCT07086443