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Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Aug 31, 2026 to Feb 28, 2027v5 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    • Eligibility criteria revised
    • Site details revised
  2. Primary completion date: Aug 31, 2025 to Aug 31, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    v4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Jun 1, 2024 to Aug 31, 2025
    • Start date changed from estimate of Jun 1, 2023 to Dec 20, 2023
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    • Site details revised
  4. Start date: Jan 1, 2023 to Jun 1, 2023
    • Primary completion date: Dec 31, 2023 to Jun 1, 2024
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 test a new approach to the design and implementation of socket and liner technology in individuals who lost a lower limb secondary to diabetes mellitus type II (herein referred to as dysvascular amputees). The technology-based intervention will be combined with an exercise program designed to improve the health status of dysvascular amputees.
Trial Details
NCT Number NCT05656924
Lead Sponsor Spaulding Rehabilitation Hospital
Collaborators: Bionic Skins LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Diabetes Type 2, Amputation
Related terms Diabetes Mellitus, Type 2
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov