NCT06999590

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

A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating Several Cellular, Acellular, and Matrixlike Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Tiger Biosciences, LLC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study it to evaluate 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.

Detailed description

To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing pressure ulcers with multiple CAMPs plus SOC versus matched SOC controls (mSOC) over 20 weeks using a modified platform trial design. The initial plan is to evaluate two CAMPs; however, the modified platform design permits the inclusion of additional CAMPs.

Conditions

• Pressure Ulcer
• Ulcer
• Ulcer, Pressure
• Pressure Injury

Interventions

Type	Name	Description
OTHER	ACApatch™	Participants will receive weekly applications of ACApatch™ and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
OTHER	caregraFT™	Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
OTHER	Standard of Care	Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance) until ulcer closure, or a maximum of 20 weeks, whichever occurs first.

Timeline

• Start date: 2025-05-20
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-05-31
• Last updated: 2025-06-05

Locations

1 site across 1 country: United States