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

StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. Study sites: 12 to 13v15
  2. Trial sites reduced: 15 → 12 locationsv14
  3. Primary completion date: Jun 30, 2026 to Dec 31, 2026
    • Trial status: Recruiting to Enrolling by Invitation
    • Study sites: 16 to 15
    • Study completion date: Aug 31, 2026 to Mar 31, 2027
    v13
  4. Eligibility criteria shortened, about 115 wordsv12
  5. Study sites: 12 to 16v11
Show 9 earlier versionsHide 9 earlier versions
  1. Site details revised at 2 of 12 sitesv10
  2. Study sites: 8 to 12v9
  3. Study sites: 6 to 8v8
  4. Study sites: 2 to 6v7
  5. Study sites: 4 to 2v6
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 30, 2024 to Nov 18, 2024
    • Site details revised at 4 of 4 sites
    v5
  7. Re-verified, no change to tracked fieldsv4
  8. Start date: Oct 30, 2024 to Nov 30, 2024v3
  9. Start date: Jun 30, 2024 to Oct 30, 2024
    • Secondary endpoints: 5 to 6
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06453187
Lead Sponsor Integra LifeSciences Corporation
Collaborators: SerenaGroup, Inc.
Conditions
(from sponsor)		 Diabetic Foot Ulcer, Venous Leg Ulcer
Related terms Diabetic Foot, Varicose Ulcer
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov