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

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

NCT Number	NCT07116174
Lead Sponsor	New Horizon Medical Solutions Collaborators: Amarex Clinical Research
Conditions	Diabetic Foot Ulcer (DFU)
Enrollment	135 participants
Start Date	2025-08-15
Primary Completion	2026-08-15 (estimated)
Study Completion	2026-08-15 (estimated)
Updated on ClinicalTrials.gov	2026-03-31