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Examining the Effectiveness of DermGEN™ in the Treatment of Diabetic Foot Ulcers in First Nations People

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated July 3, 2024 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Dec 30, 2024 to Dec 30, 2025
    • Start date: Dec 30, 2022 to Dec 30, 2024
    • Study completion date: Dec 1, 2025 to Dec 1, 2026
    v4
  2. Primary completion date: Dec 1, 2023 to Dec 30, 2024
    • Start date: Apr 30, 2022 to Dec 30, 2022
    • Study completion date: Dec 1, 2024 to Dec 1, 2025
    v3
  3. Primary endpoints revised (15)
    • Secondary endpoints revised (4)
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The study will examine the effectiveness of a decellularized dermal matrix (i.e., DermGEN™) in improving wound healing, quality of life and associated costs of treatment of DFUs in First Nations people living in the Northwestern Ontario Communities. First Nations people with active diabetic foot (DFU) ulcer attending a wound care clinic located at the Rainy River district office. An interventional, two-arm, randomized, prospective study of (1) standard of care (control) vs. (2) DermGEN™ - a decellularized dermal matrix (treatment) will be used in the treatment and management of DFU. Patients will be randomized to each arm (n=60 per arm) based on power calculations using data from our Pilot study.
Trial Details
NCT Number NCT05251480
Lead Sponsor DeCell Technologies Inc.
Collaborators: Canadian Institutes of Health Research (CIHR), Dalhousie University, Lakehead University
Conditions
(from sponsor)		 Diabetes Mellitus, Ulcer Foot, Ulcer Healing, Diabetic Foot Ulcer, Non-healing Wound, Wound of Skin, Wound; Foot, Tissue Injury
Related terms Diabetes Mellitus, Diabetic Foot, Foot Injuries, Foot Ulcer
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov