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Omega3 Wound Fish Skin Graft in the Treatment of DFUs

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 6, 2022 (before its estimated December 30, 2022 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 30, 2020 to Dec 30, 2022
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jan 30, 2021 to Jan 30, 2023
    • Site details revised at 5 of 5 sites
    v4
  2. Primary completion date: May 30, 2020 to Dec 30, 2020
    • Study completion date: May 30, 2020 to Jan 30, 2021
    v3
  3. Re-verified, no change to tracked fieldsv2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Kerecis Ltd.
8 trials monitored
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Diabetes
5,087 trials monitored
See 222 trials at risk
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA-approved product that is derived from minimal processing of Atlantic cod fish skin: KerecisTM Omega3 Wound. In this trial, two groups of UT grade IA/1C diabetic foot ulcers (DFUs), full skin thickness or extending through the subcutaneous or fat layers but not into tendon, muscle, or bone will receive standard of care (SOC) treatment for their condition. Patients will be randomized to SOC treatment and a 510k FDA-approved collagen alginate dressing (Fibracol Plus) or SOC and KerecisTM Omega3 Wound. The primary endpoint is the percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks in which two groups that will be compared are SOC with Fibracol Plus or SOC with KerecisTM Omega3 Wound
Trial Details
NCT Number NCT04133493
Lead Sponsor Kerecis Ltd.
Conditions
(from sponsor)		 Diabetic Foot Ulcer
Related terms Diabetic Foot
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov