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Sterilised, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 31, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Jan 31, 2024 to Dec 31, 2025
    • Trial status: Completed to Active, Not Recruiting
    v3
  2. Lead sponsor: SerenaGroup, Inc. to ConvaTec Inc.v2 Show 5 more changesShow less
    • Primary completion date changed from estimate of Jun 1, 2023 to Jan 31, 2024
    • Trial status: Recruiting to Completed
    • Study completion date changed from estimate of Sep 1, 2023 to Jan 31, 2024
    • Site details revised at 5 of 5 sites
    • Study title revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
ConvaTec Inc.
11 trials monitored
See 1 trial at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
A Prospective, Non-Randomized, Multi-Center Observational Study To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs) Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading
Trial Details
NCT Number NCT05687656
Lead Sponsor ConvaTec Inc.
Conditions
(from sponsor)		 Diabetic Foot Ulcer
Related terms Diabetic Foot
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov