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
Subject is 18 years of age or older.
Subject has diabetes mellitus (Type 1 or Type 2), requiring insulin or oral/injectable medications to control blood glucose levels
Glycosylated hemoglobin (HbA1c) level is <12%
Duration of ulcer is ≥ 4 weeks but ≤ 1 year, unresponsive to SOC
Clinical evidence of ongoing infection and/or receipt of IV, oral, or topical antimicrobials.
Wheelchair bound or bed-ridden (ambulatory with assistance is acceptable).
Ulceration at the site of amputation.
Undergoing renal dialysis.
New Horizon Medical Solutions
Lead sponsor
Amarex Clinical Research
Collaborator