New Horizon Medical Solutions LLC

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

The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.