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Study identifier: NCT07116174 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Diabetic Foot Ulcer (DFU)  ·  Sponsor: New Horizon Medical Solutions

PhaseNA
Planned participants135
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Dawn Shepherd  ·  817-233-1295  ·  dawn.shepherd@nhmedical.com

Kher Lee Ng  ·  KherLeeN@amarexcro.com

Always discuss trial participation with your own doctor first.

Locations (3)

Limb Preservation Platform, Inc.Fresno, California, United StatesRecruiting
North Park PodiatrySan Diego, California, United StatesRecruiting
Richard C. GalperinDallas, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07116174