NCT06560502

Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs

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 DFUs and VLUs.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: Stability Biologics · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is 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

The purpose of this study is 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. \*The initial plan is to evaluate five CAMPs per wound type; however, the modified platform design permits the inclusion of additional CAMPs.

Conditions

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

Interventions

Type	Name	Description
OTHER	Standard of Care-DFU	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 13 weeks, whichever occurs first.
OTHER	AmnioCore - DFU	Participants will receive weekly applications of AmnioCore and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
OTHER	Amnio Quad-Core - DFU	Participants will receive weekly applications of Amnio Quad-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
OTHER	Standard of Care-VLU	Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
OTHER	Amnio Tri-Core - VLU	Participants will receive weekly applications of Amnio Tri-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
OTHER	AmnioCore Pro	Participants will receive weekly applications of AmnioCore Pro and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
OTHER	Amniocore Pro +	Participants will receive weekly applications of Amniocore Pro + and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2024-08-19
• Last updated: 2025-01-20

Locations

1 site across 1 country: United States