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RECRUITING
NCT05656924
PHASE2

Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees

Sponsor: Spaulding Rehabilitation Hospital

View on ClinicalTrials.gov

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.

Official title: Improving the Health Status of Dysvascular Amputees by Deploying Digital Prosthetic Interface Technology in Combination With an Exercise Intervention

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2023-12-20

Completion Date

2026-12-31

Last Updated

2025-04-03

Healthy Volunteers

No

Interventions

DEVICE

digital prosthetic interface technology

Individuals randomized to this group will receive a socket and liner that are manufactured using a novel technique meant to achieve a better distribution of pressure on the residuum. The study is based on the hypothesis that an improvement in pressure distribution on the residuum will enable high adherence to an exercise program meant to improve health status in dysvascular amputees.

Locations (1)

Spaulding Rehabilitation Hospital Boston

Boston, Massachusetts, United States