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NCT06453187 · ClinicalTrials.gov registry record · NA
A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers
A NA study of Diabetic Foot Ulcer and Venous Leg Ulcer, sponsored by Integra LifeSciences Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 350
- Enrollment target
- 16
- Study locations
NCT06453187 is a NA study of Diabetic Foot Ulcer and Venous Leg Ulcer that is actively recruiting participants, run by Integra LifeSciences Corporation. The registered enrollment target is 350 participants, above the 250-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (40% higher). The trial reports 16 study locations across 9 states.
The verdict
NCT06453187, a NA study of Diabetic Foot Ulcer and Venous Leg Ulcer, is actively recruiting participants, sponsored by Integra LifeSciences Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 350 participants
- Enrollment target
- 16
- Study locations
Study 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.
Conditions Studied
Interventions
- PROCEDURE Standard of Care
- DEVICE Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers
- DEVICE Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers
- DEVICE AmnioExcel Plus for Venous Leg Ulcers
- DEVICE AmnioExcel Plus for Diabetic Foot Ulcers
Study Locations (16)
Florida
- Alma Medical and Research Services, LLC - Hollywood
- Symphony Research - Jacksonville
- Lakeview Institute of Clinical Research, LLC - Leesburg
- Denali Health Plant City, LLC - Plant City
- Barry University Clinical Research - Tamarac
California
- Phase One Clinical Trials, Inc. - Bakersfield
- Angel City Research - Los Angeles
- Center for Clinical Research - San Francisco
Illinois
- SitePath Research - Evergreen Park
- Midwest Foot and Ankle Clinics - Hoffman Estates
Connecticut
- ClinTrial Medical Centers, PLLC - Hamden
Georgia
- Denali Health - Atlanta
Kansas
- Cheyenne County Hospital - Saint Francis
Maryland
- KUR Research, LLC - Columbia
New York
- Comprehensive Wound Healing Center, Northwell Health - Lake Success
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2024-11-18 |
| Est. Completion | 2026-08-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06453187
The ClinicalTrials.gov registry entry for NCT06453187 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 250-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (40% higher). The listed sponsor is Integra LifeSciences Corporation, which has 60 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 5 interventions - of which Standard of Care is the first listed.
NCT06453187 reports 16 study locations spanning 9 distinct geographic areas - top geographies include Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT06453187 about?
NCT06453187 is a clinical study titled "A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers". 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.
What is the current status of trial NCT06453187?
This trial is currently recruiting. It is a NA study. The enrollment target is 350 participants. The study started on 2024-11-18. Estimated completion is 2026-08-31.
What conditions does trial NCT06453187 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer, Venous Leg Ulcer.
What interventions are being tested in trial NCT06453187?
The interventions under investigation include: Standard of Care (PROCEDURE), Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers (DEVICE), Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers (DEVICE), AmnioExcel Plus for Venous Leg Ulcers (DEVICE), AmnioExcel Plus for Diabetic Foot Ulcers (DEVICE).
Who is sponsoring clinical trial NCT06453187?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06453187 being conducted?
This trial has 16 study locations across California, Connecticut, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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