A Multicenter Randomized Trial Comparing Cellular, Acellular, and Matrix-like Products Plus Standard Care to Standard Care Alone for Treating Nonhealing Diabetic Foot and Venous Leg Ulcers

What this Trial Is About

This research investigates the management of nonhealing diabetic foot ulcers and venous leg ulcers by comparing several Cellular, Acellular, and Matrix-like Products CAMPs combined with standard care versus standard care alone. The study uses a randomized controlled modified multi-platform design to assess wound healing over 12 weeks. The goal is to determine if adding CAMPs to standard care improves the rate of complete ulcer closure in adults with these chronic wounds. Participants receive weekly applications of either ACApatch12, caregraFT12 both derived from human placental tissue, or standard care alone. Standard care includes cleaning, debridement, moisture balance of the ulcer, and offloading. Treatments continue weekly until the ulcer closes or for a maximum of 12 weeks. Different study groups focus on diabetic foot ulcers or venous leg ulcers, each receiving one of the CAMPs plus standard care or standard care alone. During the study, participants attend weekly visits where wound closure progress is monitored. Assessments include measuring wound area, evaluating pain using a visual analogue scale, and tracking any adverse events. Researchers compare the proportion of participants who achieve complete wound closure between groups over the 12-week period. Participant safety and healing progress are closely observed throughout the trial, which lasts up to 12 weeks per individual.

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.