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Clinical Trial NCT05601869 for Amputation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Impact of Improving Footwear Options 18 Veterans Novel Treatment

Recruiting
Clinical Trial NCT05601869 is an interventional study for Amputation that is recruiting. It started on September 1, 2023 with plans to enroll 18 participants. Led by VA Office of Research and Development, it is expected to complete by March 31, 2026. The latest data from ClinicalTrials.gov was last updated on July 30, 2025.
Brief 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 var...Show More
Detailed Description
Background - 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 ...Show More
Official Title

Impact of Improving Footwear Options for Women Veterans With Amputations

Conditions
Amputation
Other Study IDs
  • D4256-R
NCT ID Number
NCT05601869
Start Date (Actual)
2023-09-01
Last Update Posted
2025-07-30
Completion Date (Estimated)
2026-03-31
Enrollment (Estimated)
18
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Artificial Limbs
Amputation
Leg Prosthesis
Body Image
Community Participation
Social Participation
Primary Purpose
Supportive Care
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIntervention
Participants in this arm receive a new prosthesis system designed to improve footwear options.
RECOVER Prosthetic Ankle-Feet System
The RECOVER prosthetic ankle-feet system includes a single prosthetic ankle joint that can be easily attached to 3D printed feet. The feet are designed to fit specifically within different footwear.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Amputation-Specific Body Image Scale-Revised (ABIS-R) Change
The ABIS-R is a 14-item scale that assesses body image disturbance among individuals with amputations. Responses are reported on a 1 to 3 scale, with higher values representing greater body image disturbance.
Baseline, 1-month, 6-months
PROMIS Ability to Participate in Social Roles and Activities (PROMIS APSRA) Change
The PROMIS Ability to Participate in Social Roles and Activities (PROMIS-APSRA) specifically measures one's ability to participate in social roles and activities, including one's ability to do leisure activities and activities with friends and family. The PROMISAPSRA is an 8-item form that uses a 5-point scale, where higher values indicate a higher degree of ability to participate.
Baseline, 1-month, 6-months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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)
VA Office of Research and Development logoVA Office of Research and Development
University of Minnesota logoUniversity of Minnesota403 active studies to explore
Study Central Contact
Contact: Andrew H Hansen, PhD, (612) 467-2910, [email protected]
Contact: Nicole Walker, MS, (612) 467-3229, [email protected]
1 Study Locations in 1 Countries

Minnesota

Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis, Minnesota, 55417-2309, United States
Andrew H Hansen, PhD, Contact, 612-467-2910, [email protected]
Nicole Walker, MS, Contact, (612) 467-3229, [email protected]
Andrew H Hansen, PhD, Principal Investigator
Recruiting