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.
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 consent to using the prescribed offloading method for the duration of the study.
The potential subject must agree to attend the weekly study visits required by the protocol.
The potential subject must be willing and able to participate in the informed consent process.
The potential subject is known to have a life expectancy of < 6 months.
Parallel
ACApatch™
Other interventionParticipants will receive weekly applications of ACApatch™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
caregraFT™
Other interventionParticipants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Standard of Care
Other interventionBeginning 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.
6
Treatment groupsSee each treatment group below.
The between-arm difference in subjects that complete wound closure
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. The platform design permits the inclusion of additional products by amending the protocol.
Difference between CAMP plus SOC versus SOC alone in subjects that complete wound closure
To determine the between-arm difference in the time to closure over 12 weeks for CAMP plus SOC versus SOC alone.
Percent Area Reduction
To determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus SOC alone.
VAS
To determine the between-arm difference in pain for patients that present with a VAS score of greater than 4.
Adverse Events
To evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus SOC alone.
Wound Quality of Life
To evaluate the between-arm difference in the quality of life for subjects receiving CAMP plus SOC compared to SOC alone using the Forgotten Wound Score (FWS) at treatment visits 1, 4, 8, and 12.
Wound Quality of Life
To evaluate the between-arm difference in the quality of life for subjects receiving CAMP plus SOC compared to SOC alone using the standard Wound Quality of Life (wQOL) questionnaires at treatment visits 1, 4, 8, and 12.
Age
To determine the proportion of ulcers that close in patients 65 years or older for CAMP plus SOC versus SOC alone.
Functional Ambulatory Category Scale
3\. To evaluate the between-arm difference in functional ambulation based on Functional Ambulatory Category Scale (FACS) - VLU subjects only.
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Tiger Biosciences, LLC.
Lead sponsor
SerenaGroup, Inc.
Collaborator
