NCT06674980

Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs

A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: C5 Biomedical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.

Detailed description

The C5CAMP trial is a multicenter, prospective, randomized controlled clinical trial to evaluate subjects that meet medical necessity criteria for cellular, acellular, and matrix-like products (CAMPs). The study utilizes a prospective modified platform design to evaluate two separate CAMPs, AM/Single and AM/Double in a single trial. The initial plan is to evaluate two CAMPs; however, the modified platform design permits the inclusion of additional CAMPs. 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

• Pathologic Processes
• Diabetes Mellitus
• Glucose Metabolism Disorders
• Metabolic Diseases
• Endocrine System Disease
• Diabetic Angiopathies
• Vascular Diseases
• Cardiovascular Diseases
• Leg Ulcer
• Skin Ulcer
• Skin Diseases
• Diabetes Complications
• Diabetic Neuropathies
• Foot Diseases
• Diabetic Foot
• Foot Ulcer
• Diabetes Mellitus, Type 2
• Ulcer
• Foot Ulcer Unhealed

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 12 weeks, whichever occurs first.
OTHER	AM/Single - DFU	Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	AM/Double - DFU	Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 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 12 weeks, whichever occurs first.
OTHER	AM/Single - VLU	Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	AM/Double - VLU	Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Timeline

• Start date: 2024-12-20
• Primary completion: 2026-11-22
• Completion: 2027-01-22
• First posted: 2024-11-05
• Last updated: 2024-12-27

Locations

1 site across 1 country: United States