Study Comparing New Cellular and Matrix Products Plus Standard Care to Standard Care Alone for Healing Nonhealing Pressure Ulcers in Adults

What this Trial Is About

The trial investigates the management of nonhealing pressure ulcers using several cellular, acellular, and matrix-like products CAMPs combined with standard of care compared to matched standard of care controls. The goal is to determine differences in the rate of complete closure of pressure ulcers over 20 weeks using a modified platform trial design. Initially, two CAMPs will be studied, with the option to add more during the trial. Participants will be randomly assigned to one of three groups weekly applications of ACApatch plus standard of care, weekly applications of caregraFT plus standard of care, or standard of care alone. Standard of care includes cleaning, debridement, and ulcer moisture balance. Treatments continue weekly until ulcer closure or for a maximum of 20 weeks. During the study, participants will attend weekly visits for treatment and ulcer assessment. Researchers will measure complete wound closure, time to closure, percentage area reduction, quality of life, and adverse events over the 20-week period. The study is designed to monitor healing progress and safety throughout the treatment duration.

Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers