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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07159282
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