Improving footwear options for women Veterans with leg amputations
Official title: Impact of Improving Footwear Options for Women Veterans With Amputations
Run by VA Office of Research and Development · NCT05601869 · Data updated 2026-11-12
This study tests a new ankle-foot prosthetic designed for women Veterans with leg amputations to see if it helps them feel better about themselves and participate more in their communities while wearing different types of shoes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 89 Years |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | September 1, 2023 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | April 7, 2026 |
| Trial ID | NCT05601869 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women Veterans with transtibial amputations who have been using a well-fitted prosthesis for at least six months.
✕Probably not a fit
Patients who may not benefit from this study include those with skin problems on the residual limb, those who are not regular prosthesis users, or those with significant neurocognitive disorders.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project evaluates a new prosthetic ankle-feet system designed for women Veterans with transtibial amputations, allowing them to wear a wider variety of footwear. The study aims to assess the impact of this innovative prosthesis on body image and community participation over a six-month take-home trial. Participants will be women Veterans who have been using a definitive prosthesis for at least six months and have access to technology for data collection. The research seeks to address the dissatisfaction women Veterans experience with traditional prosthetics.
Why it matters
Potential benefit: If successful, this study could significantly enhance the quality of life for women Veterans by improving their body image and community engagement through better footwear options.
How similar studies have gone: While there is limited research specifically on this novel approach, previous studies indicate that addressing footwear options can improve satisfaction and quality of life for amputees.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
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Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Andrew H Hansen, PhD — Minneapolis VA Health Care System, Minneapolis, MN
- Study coordinator: Andrew H Hansen, PhD
- Email: andrew.hansen2@va.gov
- Phone: (612) 467-2910
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.