A Randomized Controlled Multicenter Trial, Examining the Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
Royal Biologics
Summary
This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). The study will evaluate Amnio-Maxx® Dual Layer Amnion Patch.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Potential subjects are required to meet all the following criteria for enrollment into the study and subsequent randomization. 1. The potential subject is 18 years of age or older. At least 50% of the enrolled population must be \> 65 years of age. 2. The potential subject has a history of Type I or Type II Diabetes Mellitus requiring treatment by a physician with either oral medications and/or insulin replacement therapy. 3. Potential subjects have an ulcer characterized by the following: 1. Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screening…