Impact of Improving Footwear Options (NCT05601869) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Improving Footwear Options
United States18 participantsStarted 2023-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* US military Veterans that identify as women
* Transtibial (below-knee) amputation
* Using a definitive prosthesis for at least 6 months (limb has accommodated to prosthesis use post-amputation)
* Well fitting and well aligned prosthesis
* Blessed Orientation-Memory-Concentration (Short Blessed) score between 0-6
* Access to computer, tablet, or smart phone and internet for video conferencing and RedCap data collection
Exclusion Criteria:
* Residual limb skin problems
* Residual limb too long to accommodate the RECOVER prosthetic ankle-feet system
* Unable or unwilling to travel to Minneapolis
* Not a regular prosthesis user
* Mass over 125 kg
* Documented neurocognitive disorder (e.g., dementia) with evidence of impact on activities of daily living and/or instrumental activities of daily living
* Baseline ABIS-R or PROMIS-APSRA scores at the maximum levels (no room for improvement on primary outcomes)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Amputation-Specific Body Image Scale-Revised (ABIS-R) Change
Timeframe: Baseline, 1-month, 6-months
2
PROMIS Ability to Participate in Social Roles and Activities (PROMIS APSRA) Change