A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.
Tiger Biosciences, LLC.
Summary
Title A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care versus Standard of Care alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.
Description
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design.
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria:(DFU) * Subjects The potential subject must be at least 21 years of age or older. * The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus. * At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement. * The potential subject must have a target ulcer that has been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit. * The potential subject must have a target ulcer located on the foot…
Interventions
- OtherACApatch™
Participants will receive weekly applications of ACApatch™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
- OthercaregraFT™
Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
- OtherStandard of Care
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Location
- Serena GroupMonroeville, Pennsylvania