Pure Global
NCT05601869

Impact of Improving Footwear Options

Impact of Improving Footwear Options for Women Veterans With Amputations
VA Office of Research and Development·ClinicalTrials.gov·device·Device trialNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Amputation
Drug/Device/Intervention
UNYQ Prosthetic Ankle-Feet System
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
VA Office of Research and Development
Location
Minneapolis, United States of America
Timeline & enrollment
Phase
N/A
Start date
Jul 03, 2023
End date
Dec 31, 2025
Enrollment
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 feetTraumatic amputation of upper and lower limbs, any combination [any level]Traumatic amputations involving other combinations of body regionsTraumatic amputation of lower leg
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05601869
Type
Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.