NCT06562296

Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers

Multicenter, Prospective, Randomized Controlled Matriarch Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus SOC Alone of Nonhealing Diabetic Foot and Venous Leg Ulcers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: Cellution Biologics · Industry
• Sex: All
• Age: 18 Years – 98 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot and venous leg ulcers.

Detailed description

Chronic wounds affect a significant percentage of patients over their lifetime. For example, diabetic foot ulcers (DFU) are a major health complication that affect up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of chronic wounds is extremely challenging as ulcers such as DFUs and Venous Leg Ulcers (VLUs) may not respond to standard of care (SOC) treatment and frequently become infected. Advanced wound products like CAMPs have become an important strategy in the treatment of these chronic wounds by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing. This study will evaluate the clinical utility of Multiple CAMPs in the closure of diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment.

Conditions

• Diabetic Foot Ulcer
• Venous Leg Ulcer

Interventions

Type	Name	Description
OTHER	Amnion-Intermediate-Chorion	Dehydrated human placental multilayer allograft from derived donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.
OTHER	Amnion-Chorion-Amnion	Dehydrated human placental trilayer allograft derived from donated human tissue.
PROCEDURE	Standard of Care	Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.

Timeline

• Start date: 2024-10-14
• Primary completion: 2025-06-11
• Completion: 2026-01-16
• First posted: 2024-08-20
• Last updated: 2026-04-13

Locations

4 sites across 1 country: United States