RecruitingPhase 4NCT07126886

A Multicenter, Prospective, Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care Versus Matched Controls in the Management of Nonhealing Pressure Ulcers


Sponsor

Applied Biologics, LLC

Enrollment

100 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A multicenter, prospective, clinical trial evaluating a single-layer amniotic membrane (XPURT) and standard of care versus matched controls in the management of nonhealing pressure ulcers.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Standard of Care and XPURT + SOC for people with pressure area, pressure wound, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

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 20 weeks, whichever occurs first.

OTHERXPURT + SOC

Participants will receive weekly applications of XPURT and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.


Locations(1)

Serena Group- Monroeville

Monroeville, Pennsylvania, United States

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NCT07126886


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