RecruitingPhase 4NCT07086443

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


Sponsor

Sequence LifeScience, Inc.

Enrollment

350 participants

Start Date

Jul 11, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing new wound care treatments for diabetic foot ulcers — open sores on the foot that are common in people with diabetes and often very slow to heal. Researchers want to find out if specialized wound therapies can help these stubborn ulcers heal faster than standard care. **You may be eligible if...** - You are 18 or older - You have type 1 or type 2 diabetes - You have a foot ulcer between 1.0 and 15.0 cm2 in size (measured after wound cleaning) - The ulcer has been present for at least 4 weeks despite standard wound care - The ulcer is located on the foot, mostly below the ankle bone - The ulcer does not extend down to the bone or tendon **You may NOT be eligible if...** - Your ulcer is infected or has signs of serious bone infection (osteomyelitis) - Your blood flow to the foot is severely impaired - You have had recent surgery on the affected foot - You are pregnant or breastfeeding 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

OTHERActivate™ Matrix

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

OTHERAmnioDefend™ FT Matrix

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.

OTHERPalisade™ DM Matrix

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.

OTHEREnclose™ TL Matrix

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.

OTHERSentry™ SL Matrix

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.

OTHERShelter™ DM Matrix + SOC

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)

Serena Group- Monroeville

Monroeville, Pennsylvania, United States

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NCT07086443


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