RecruitingNot ApplicableNCT07116174

A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs

A Prospective, Multi-center, Randomized Controlled Clinical Trial Evaluating the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) as Adjunct to Standard of Care (SOC) Therapy Compared to SOC Alone in the Management of Diabetic Foot Ulcers


Sponsor

New Horizon Medical Solutions

Enrollment

135 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the clinical outcomes of Diabetic Foot Ulcers (DFUs) treated with a weekly application of Xcell Amnio MatrixTM (XAM) as adjunct to standard of care (SOC) compared to SOC alone in male and female over the age of 18 years old. The main question it aims to answer is: What is the proportion of subjects with complete wound closure during the 12 weeks of the treatment phase? Participants: * Will be screened and re-screened after 2 weeks to be assessed whether they meet the eligibility criteria * Eligible subjects will receive study product application, and for 12 weeks will return to the clinic once every 7 days (±3 days) for treatment visits * Subjects who complete the treatment will be followed up after 2 weeks


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Standard of Care (SOC) and a biological treatment called Xcell Amnio Matrix for people with diabetic foot ulcer (dfu). The study is currently recruiting participants at 3 locations.

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

BIOLOGICALXcell Amnio Matrix

A lyophilized amniotic membrane allograft

DRUGStandard of Care (SOC)

The SOC will be based on investigator's choice


Locations(3)

Limb Preservation Platform, Inc.

Fresno, California, United States

North Park Podiatry

San Diego, California, United States

Richard C. Galperin

Dallas, Texas, United States

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NCT07116174


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