Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients

Study acronym: TriO FITT
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Study completion date changed from estimate of Jan 2026 to Dec 1, 2025
    • Enrollment target: estimated 20 to confirmed 19
    • Primary completion date changed from estimate of Dec 2025 to Nov 23, 2025
    • Eligibility criteria expanded, about 7 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jun 2025 to Dec 2025
    • Study completion date: Jul 2025 to Jan 2026
    • Site details revised
    v4
  3. Primary endpoints revised (4)
    • Interventions: Biochemistry Blood Test (Diagnostic Test), Hematology Blood Tests (Diagnostic Test), Numeric Pain Rating Scale (Other), Physical… to Biochemistry Blood Test (Diagnostic Test), Hematology Blood Tests (Diagnostic Test), Physical Examination (Diagnostic Test), SF-36 (Other)…
    v3
  4. Primary completion date: Dec 2024 to Jun 2025
    • Study completion date: Jan 2025 to Jul 2025
    v2
  5. Study First Submitted
  • 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 TriO FITT device is designed to improve the symptoms of chronic diabetic ulcers. The mechanism of action of the device optimizes and combines the administration known supproting treatments to chronic diabetic ulcers. The treatment is astimated to improve the wound conditions of acute and chronic diabetic wounds.
Trial Details
NCT Number NCT06003400
Lead Sponsor Tri.O Medical LTD
Conditions
(from sponsor)		 Diabetic Foot Ulcer
Related terms Diabetic Foot
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov