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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: Recruiting NA study of Diabetic Foot Ulcer and Venous Leg Ulcer, sponsored by Integra LifeSciences Corporation.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

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

FieldValue
Enrollment Target 350 participants
Start Date 2024-11-18
Est. Completion 2026-08-31
Phase NA
Integra LifeSciences Corporation

60 total trials

What NCT06453187 shows while recruiting

NCT06453187 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, above the 250-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (40% higher).

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 lists 16 locations in 9 states (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.

Similar trials for Diabetic Foot Ulcer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06453187's enrollment target sits among peer trials

350 7th of 67 higher than 60 of 67 other Diabetic Foot Ulcer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetic Foot Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06453187, the US trial registry maintained by the National Library of Medicine. NCT06453187 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.