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Impact of Improving Footwear Options - Trial NCT05601869

Access comprehensive clinical trial information for NCT05601869 through Pure Global AI's free database. This phase not specified trial is sponsored by VA Office of Research and Development and is currently Not yet recruiting. The study focuses on Amputation. Target enrollment is 18 participants.

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Trial Details
ClinicalTrials.gov โ€ข NCT05601869
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Impact of Improving Footwear Options
Impact of Improving Footwear Options for Women Veterans With Amputations

Study Focus

Amputation

UNYQ Prosthetic Ankle-Feet System

Interventional

device

Sponsor & Location

VA Office of Research and Development

Minneapolis, United States of America

Timeline & Enrollment

N/A

Jul 03, 2023

Dec 31, 2025

18 participants

Primary Outcome

Amputation-Specific Body Image Scale-Revised (ABIS-R) Change,PROMIS Ability to Participate in Social Roles and Activities (PROMIS APSRA) Change

Summary

Veterans with leg amputations have limited footwear options because their artificial feet do
 not change shapes for different shoes. Studies have shown that women with amputations receive
 more frequent prosthetics care than men, but are less satisfied with the fit, comfort, and
 appearance of their prostheses. The investigators' previous research indicates that women
 Veterans would like to be able to wear a broader variety of footwear, and those who perceive
 more footwear limitations tend to have poorer body image and community participation. A new
 prosthesis designed by the investigators' group allows Veterans with amputations to use their
 footwear of choice using 3D-printed artificial feet with a single ankle. The novel prosthesis
 will be tested in this project with women Veterans with amputations to determine the impact
 of improving footwear options on body image and community participation.

ICD-10 Classifications

Amputation of limb(s)
Traumatic amputation of both feet
Traumatic amputation of upper and lower limbs, any combination [any level]
Traumatic amputations involving other combinations of body regions
Traumatic amputation of lower leg

Data Source

ClinicalTrials.gov

NCT05601869

Device Trial