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A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers
NCT06453187 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Integra LifeSciences Corporation, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06453187 reports 16 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06453187?
This trial is sponsored by Integra LifeSciences Corporation, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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