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NCT05656924
Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees
Conditions: Diabete Type 2, Amputation
Sex: All
Ages: 18 Years – 70 Years
Phase: PHASE2
Enrollment: 38
Sponsor: Spaulding Rehabilitation Hospital
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Unilateral transtibial amputation within the past 4-16 monthsEtiology secondary to complications of Diabetes Mellitus (DM) type IICurrent use of a prosthesis, with at least 2 months prior useK2 or K3 level (as determined using the Amputee Mobility Predictor assessment tool)Own a smartphoneExclusion Criteria:Amputation due to cancer or macrotrauma or acute hemorrhageBilateral amputationMedically 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 programMedical conditions that would interfere with subject's participation in regular sustained exerciseAnthropometric 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
Source: ClinicalTrials.gov (NCT05656924). StuddyBuddy aggregates publicly available trial information.