RecruitingPhase 4NCT07159282

A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers


Sponsor

Applied Biologics, LLC

Enrollment

60 participants

Start Date

Aug 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a single-layer placental-based skin graft (derived from donated placenta tissue) can help heal diabetic foot ulcers that have not closed after 12 weeks of standard care. It is specifically for patients who were previously in a related trial called CAMPX and did not achieve complete healing. **You may be eligible if...** - You are 18 or older - You have Type 1 or Type 2 diabetes - You previously participated in the CAMPX trial and your ulcer did not heal within 12 weeks - You are willing to wear the prescribed offloading device and attend weekly visits **You may NOT be eligible if...** - Your life expectancy is less than 6 months - Your foot ulcer is not caused by diabetes - Your ulcer is infected or has signs of surrounding skin infection - Your ulcer exposes bone or tendon - There is evidence of bone infection (osteomyelitis) 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

OTHERXWRAP

Application of XWRAP + standard of care for up to 12 weeks.


Locations(1)

Royal Research

Hollywood, Florida, United States

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NCT07159282


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