Overview

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

Status:
NOT_YET_RECRUITING
Trial end date:
2026-08-15
Target enrollment:
Participant gender:
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 percentage of wound area will change 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
Phase:
NA
Details
Lead Sponsor:
New Horizon Medical Solutions
Collaborator:
Amarex Clinical Research
Treatments:
Standard of Care