Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
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 DFUs and VLUs.
About This Trial
This is 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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
View original clinical language
Treatments Being Tested
Standard of Care-DFU
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 13 weeks, whichever occurs first.
AmnioCore - DFU
Participants will receive weekly applications of AmnioCore and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Amnio Quad-Core - DFU
Participants will receive weekly applications of Amnio Quad-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Standard of Care-VLU
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Amnio Tri-Core - VLU
Participants will receive weekly applications of Amnio Tri-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
AmnioCore Pro
Participants will receive weekly applications of AmnioCore Pro and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
Amniocore Pro +
Participants will receive weekly applications of Amniocore Pro + and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.