Multicenter Study Comparing Five Cellular and Matrix-like Products Plus Standard Care Against Standard Care Alone for Treating Nonhealing Pressure Ulcers

What this Trial Is About

This trial studies individuals with nonhealing pressure ulcers, also called chronic skin ulcers, to evaluate several cellular, acellular, and matrix-like products combined with standard care compared to standard care alone. It is a multicenter, prospective, modified platform trial involving 2,000 participants treated at up to 25 sites. The goal is to understand differences in healing and closure of these difficult wounds. Participants are randomly assigned to one of five treatment groups, each receiving weekly applications of a specific matrix product plus standard care. The products include Activate12 Matrix, AmnioDefend12 FT Matrix, Palisade12 DM Matrix, Sentry12 SL Matrix, or Shelter12 DM Matrix. Treatment continues weekly for up to 20 weeks or until the ulcer fully closes, with optional weekly visits for dressing changes. Throughout the study, participants attend weekly visits where investigators assess the ulcers using imaging and clinical evaluation. Researchers measure outcomes such as complete ulcer closure, time to closure, percentage reduction in ulcer area, pain levels, and adverse events over the 20-week period. Participants are monitored closely until the study ends, with the total participation lasting up to 20 weeks.

Study Title: A Multicenter, Prospective, Modified Platform Trial 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.