A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers

Not Applicable

Recruiting

• Conditions: Venous Leg Ulcer; Diabetic Foot Ulcer
• Interventions: Procedure: Standard of Care; Device: Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers; Device: AmnioExcel Plus for Venous Leg Ulcers; Device: AmnioExcel Plus for Diabetic Foot Ulcers; Device: Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers

• Registration Number: NCT06453187
• Lead Sponsor: Integra LifeSciences Corporation

Brief 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 hard-to-heal diabetic foot and venous leg ulcers.

Detailed Description

Hard to heal 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 hard to heal chronic wounds is extremely challenging as ulcers such as DFUs and Venous Leg Ulcers (VLUs) may not respond to standard of care (SC) treatment and frequently become infected.

Advanced wound products like CAMPs have become an important strategy in the treatment of hard-to-heal chronic wounds by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing.

The study will evaluate the clinical utility of Multiple CAMPs in the closure of hard to heal diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment.

Study Timeline

• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-07
• Study First Posted: 2024-06-11
• Study Start: 2024-11-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-06-30
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	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.
Venous Leg Ulcers with a Urinary Bladder Matrix (UBM) sheet device	Standard of Care	Participants will receive treatment with Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and 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.
Venous Leg Ulcers with AmnioExcel Plus	Standard of Care	Participants will receive treatment with AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and 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.
Venous Leg Ulcers with a Urinary Bladder Matrix (UBM) sheet device	Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers	Participants will receive treatment with Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and 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.
Diabetic Foot Ulcers with Urinary Bladder Matrix (UBM) sheet device	Standard of Care	Participants will receive treatment with Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and 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.
Venous Leg Ulcers with AmnioExcel Plus	AmnioExcel Plus for Venous Leg Ulcers	Participants will receive treatment with AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and 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.
Diabetic Foot Ulcers with AmnioExcel Plus	Standard of Care	Participants will receive treatment with AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and 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.
Diabetic Foot Ulcers with AmnioExcel Plus	AmnioExcel Plus for Diabetic Foot Ulcers	Participants will receive treatment with AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and 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.
Diabetic Foot Ulcers with Urinary Bladder Matrix (UBM) sheet device	Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers	Participants will receive treatment with Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and 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.

Primary Outcome Measures

Name	Time	Method
Percentage of complete wound closure for target ulcer	1-12 weeks	The percentage of target ulcers, DFU and VLU, achieving complete wound closure Complete wound closure is defined as 100% re-epithelialization of the ulcer surface without detectable exudate

Secondary Outcome Measures

Name	Time	Method
Time to complete wound closure for target ulcer	1-12 weeks	Time to closure will be determined for each treatment group and compared to SOC
Percentage of wound area reduction for target ulcer	1-12 weeks	Percent Area Reduction (PAR) will be calculated from measurements at Week 1 compared to measurements at week 12
Adverse Events	1-14 weeks	Incidence of adverse events will be evaluated weekly from the first study visit to the Closure Confirmation Visit (CCV).
Changes to pain associated with the target ulcer	1-14 weeks	Change in target ulcer pain assessed weekly from the first study visit to the Closure Confirmation Visit (CCV), using a 0 to 10 Pain scale with 0 = "No Pain" and 10 = "Most Intense Pain Imaginable".
Determine improvement in Quality of Life	1-14 weeks	Quality of Life assessed at the study randomization visit and the Closure Confirmation Visit (CCV), using a Minimal Important Difference (MID) of 0.50 based on the averaged overall score from 0 to 4 of all items the Wound Quality of Life (wQOL) checklist, with higher score indicating worse wQOL
Improvement of the Forgotten Wound Score (FWS)	1-14 weeks	Forgotten Wound Score (FWS) assessed at the study randomization visit and the Closure Confirmation Visit (CCV) based a 0 to 100 scale with higher indicating a high degree of "forgetting" the wound

Trial Locations

Locations (6)

Phase One Clinical Trials, Inc.; 🇺🇸 Bakersfield, California, United States

Angel City Research; 🇺🇸 Los Angeles, California, United States

Denali Health Plant City, LLC; 🇺🇸 Plant City, Florida, United States

Cheyenne County Hospital; 🇺🇸 Saint Francis, Kansas, United States

Health Goods Management, LLC; 🇺🇸 Winter Park, Florida, United States

SerenaGroup; 🇺🇸 Monroeville, Pennsylvania, United States