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

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NCT06453187 · readout in 134 d

Sponsored by Integra LifeSciences Corporation (industry) · IART — their whole pipeline →. With SerenaGroup, Inc..

Phase
Not applicable
Status
Enrolling by invitation
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
350estimated
Sites
13
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2024-11-18actualWhen the study began enrolling
Primary completion2026-12-31estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2027-03-31estimatedThe whole study's end, after follow-up
First posted2024-06-11actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-27actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Diabetic Foot Ulcer
  • Venous Leg Ulcer

Interventions

  • 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
  • Procedure: Standard of Care

Primary outcome

what the primary-completion date above is the date OF
Percentage of complete wound closure for target ulcer
measured 1-12 weeks

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