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Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees

NCT05656924 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

  • Diabetes Type 2
  • Amputation

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.

Sponsors & Collaborators

  • Bionic Skins LLC

    collaborator UNKNOWN

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Spaulding Rehabilitation Hospital

    lead OTHER

Principal Investigators

  • Paolo Bonato, PhD · Spaulding Rehabilitation Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2027-02-28
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05656924 on ClinicalTrials.gov