Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees
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.
Conditions:
🦠 Diabete Type 2 🦠 Amputation
🗓️ Study Start (Actual) 20 December 2023
🗓️ Primary Completion (Estimated) 31 August 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 38
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Unilateral transtibial amputation within the past 4-16 months
    • * Etiology secondary to complications of Diabetes Mellitus (DM) type II
    • * Current use of a prosthesis, with at least 2 months prior use
    • * K2 or K3 level (as determined using the Amputee Mobility Predictor assessment tool)
    • * Own a smartphone

    Exclusion Criteria:

    • * Amputation due to cancer or macrotrauma or acute hemorrhage
    • * Bilateral amputation
    • * Medically or surgically unstable contralateral lower extremity as determined by medical criteria (e.g., critical limb ischemia)
    • * Severe residual limb pain that limits function preventing participation in an exercise-based program
    • * Medical conditions that would interfere with subject's participation in regular sustained exercise
    • * Anthropometric characteristics that are not compatible with the technology used to scan the residuum and manufacture the liner and socket (e.g., a residuum circumference greater than 32 inches would not be compatible with the device used to scan the residuum)
    • * Current pregnancy
Ages Eligible for Study: 18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 December 2022
  • First Submitted that Met QC Criteria 8 December 2022
  • First Posted 19 December 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 June 2024
  • Last Update Posted 21 June 2024
  • Last Verified June 2024