NCT06826339

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.

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.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Tiger Biosciences, LLC. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Venous Leg Ulcer
• Venous Leg
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer Foot
• Leg Ulcer
• Ulcer Venous
• Ulcer

Interventions

Type	Name	Description
OTHER	ACApatch™	Participants will receive weekly applications of ACApatch™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	caregraFT™	Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 12 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, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Timeline

• Start date: 2024-12-06
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-02-13
• Last updated: 2025-02-13

Locations

1 site across 1 country: United States