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

Not Applicable

Recruiting

• Conditions: Pathologic Processes; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Disease; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer

• Registration Number: NCT06674980
• Lead Sponsor: C5 Biomedical

Brief 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.

Study Timeline

• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-04
• Study First Posted: 2024-11-05
• Status Verified: 2024-12
• Study Start: 2024-12-20
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-11-22
• Study Completion: 2027-01-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Determine the percentage of subjects achieving complete closure of target ulcer over 12 weeks.	1-12 weeks	The proportion of subjects achieving complete wound closure of target ulcer.

Secondary Outcome Measures

Name	Time	Method
Time to closure for target ulcer.	1-12 weeks	Length of time in days to closure will be determined for each treatment group and compared to SOC alone.
Percent Area Reduction (PAR)	1-12 weeks	Percent Area Reduction (PAR) will be calculated from Treatment Visit (TV)-1 to TV-13 measured weekly with digital photographic planimetry, using imaging device, and physical examination.
Adverse Events	1-12 weeks	Determine number of adverse events
Change in pain in target ulcer	1-12 weeks	Change in pain in target ulcer assessed using the Pain, Enjoyment of Life and General Activity (PEG) scale
Determine improvement in quality of life	1-12 weeks	Quality of life assessed using the Wound Quality of Life (wQOL) at TV-1, TV-4, TV-8, TV-12 / Final Visit

Trial Locations

Locations (1)

Poirot Podiatry; 🇺🇸 Metairie, Louisiana, United States