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Mirragen Diabetic Foot Ulcer Study

StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Minor Trial completed Show 5 more changesShow less
    • Final enrollment: 10 participants (planned 20)
    • Primary completion date changed from estimate of Jul 2026 to Sep 9, 2026
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: details revised at 3 of 9 entries
    • Site details revised
  2. Minor Primary completion date: May 2026 to Jul 2026
    • Study completion date: Nov 2026 to Dec 2026
    • Site contact updated
    v4
  3. Notable Primary completion date: Apr 2025 to May 2026
    • Study completion date: Oct 2025 to Nov 2026
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2024 to Sep 20, 2024
    • Study site revised
    v2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is being done to collect data from treatment of patients who have diabetes with non-healing foot wounds and are being treated with a resorbable and biocompatible borate-based bioactive glass fiber matrix. A borate-based bioactive glass fiber matrix is used to cover the ulcer for wound management. The primary objective of this study is to evaluate the safety and efficacy of the borate-based bioactive glass fiber matrix in the treatment of diabetic foot ulcers in a real-world setting. The secondary objective is to evaluate the clinical and financial benefits in terms of quality of healing, pain, and treatment cost.
Trial Details
NCT Number NCT06598241
Lead Sponsor The University of Texas Health Science Center at San Antonio
Conditions
(from sponsor)
Diabetic Foot Ulcer, Osteomyelitis Chronic
Related terms Diabetic Foot
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov