AmputationNCT05601869
Impact of Improving Footwear Options
A study testing RECOVER Prosthetic Ankle-Feet System in people with Amputation, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Amputation
- What is being tested?
- RECOVER Prosthetic Ankle-Feet System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Andrew H Hansen, PhD, 612-467-2910, andrew.hansen2@va.gov
Nicole Walker, MS, (612) 467-3229, nicole.walker6@va.gov
About this study
Official title: Impact of Improving Footwear Options for Women Veterans With Amputations
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.
Read the 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 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 investigators seek to understand the impact of improving footwear options for women Veterans with amputations on body image and community participation following a 6-month take-home trial.
Research Questions (Objectives) - The purpose of this project is to evaluate the effect of a new prosthetic ankle-feet system on body image and participation among women Veterans with lower limb amputations.
Relevance to VA - Women Veterans with amputations is a small but growing demographic of US military Veterans. Women with amputations receive more frequent prosthetics care, but are less satisfied with the fit, comfort, and appearance of their prostheses than men. These findings are not surprising as most prosthesis components are not gender-specific and seem to have been designed for men. The investigators' group has developed a 3D-printed ankle feet system customized to fit a wide range of footwear, including shoes of different heel heights and widths. This new prosthesis system dramatically improves footwear options for persons using leg prostheses, enabling potential to increase body image and community participation for women Veterans with leg amputations. This study is an important next step in the investigators' line of research and is needed to determine the impact of improving footwear options for this important and growing subpopulation of Veterans.
Number of Research Participants (Sample Size) - We will recruit up to 18 women Veterans with transtibial amputations to participate and anticipate that at least 12 participants will complete the entire study. The investigators plan to screen women Veterans from a national sample to accomplish the recruitment and completion goals.
Participating Sites - Minneapolis VA Health Care System
Duration of Participant Intake (Study Duration) - This project is projected to occur over three years. The project will begin with a 6-month start-up period and recruitment will continue for two years following start-up. Recruitment will conclude with 6-months remaining in the study timeline, which will be used for dissemination of results and closure of the project.
Treatment (follow-up) - The intervention being tested is a new prosthetic ankle-feet prosthesis that women Veterans will wear for 6-months in their home and community environments. The investigators will follow-up with participants after 1-month and after 6-months of home and community use.
Endpoints - The primary outcomes for this study are body image (Amputee-specific Body Image Scale - Revised) and ability to participate in social roles and activities (PROMIS - Ability to Participate in Social Roles and Activities).
Qualitative Data - In addition to measuring body image and participation, the investigators will conduct semi-structured interviews will participants to develop further understanding of the benefits and drawbacks of using the new prosthetic ankle-feet system. Participants will also complete a photovoice task in which they will be asked to take photos regarding their experience using the new prosthetic ankle-feet system. These photos will then be used as talking points during the semi-structured interview to improve the understanding of the user experience with the system.
- Conditions
- Amputation
- Being tested
- RECOVER Prosthetic Ankle-Feet System
- Keywords
- Artificial Limbs, Amputation, Leg Prosthesis, Body Image, Community Participation, Social Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECOVER Prosthetic Ankle-Feet SystemDevice
Also called RECOVER AFS
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in this arm receive a new prosthesis system designed to improve footwear options. Receives: Device: RECOVER Prosthetic Ankle-Feet System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 1-month, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Sep 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pretest-Posttest Design
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Andrew H Hansen, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601869
- Sponsor's protocol ID
- D4256-R
- Status last verified
- Apr 2026
- First submitted
- 27 Oct 2022
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Improving Footwear Options for Women Veterans With Amputations
- ClinicalTrials.gov ID
- NCT05601869
- Acronym / sponsor ID
- D4256-R
- Conditions
- Amputation
- Keywords
- Artificial Limbs, Amputation, Leg Prosthesis, Body Image, Community Participation, Social Participation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Minnesota
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 investigators seek to understand the impact of improving footwear options for women Veterans with amputations on body image and community participation following a 6-month take-home trial.
Research Questions (Objectives) - The purpose of this project is to evaluate the effect of a new prosthetic ankle-feet system on body image and participation among women Veterans with lower limb amputations.
Relevance to VA - Women Veterans with amputations is a small but growing demographic of US military Veterans. Women with amputations receive more frequent prosthetics care, but are less satisfied with the fit, comfort, and appearance of their prostheses than men. These findings are not surprising as most prosthesis components are not gender-specific and seem to have been designed for men. The investigators' group has developed a 3D-printed ankle feet system customized to fit a wide range of footwear, including shoes of different heel heights and widths. This new prosthesis system dramatically improves footwear options for persons using leg prostheses, enabling potential to increase body image and community participation for women Veterans with leg amputations. This study is an important next step in the investigators' line of research and is needed to determine the impact of improving footwear options for this important and growing subpopulation of Veterans.
Number of Research Participants (Sample Size) - We will recruit up to 18 women Veterans with transtibial amputations to participate and anticipate that at least 12 participants will complete the entire study. The investigators plan to screen women Veterans from a national sample to accomplish the recruitment and completion goals.
Participating Sites - Minneapolis VA Health Care System
Duration of Participant Intake (Study Duration) - This project is projected to occur over three years. The project will begin with a 6-month start-up period and recruitment will continue for two years following start-up. Recruitment will conclude with 6-months remaining in the study timeline, which will be used for dissemination of results and closure of the project.
Treatment (follow-up) - The intervention being tested is a new prosthetic ankle-feet prosthesis that women Veterans will wear for 6-months in their home and community environments. The investigators will follow-up with participants after 1-month and after 6-months of home and community use.
Endpoints - The primary outcomes for this study are body image (Amputee-specific Body Image Scale - Revised) and ability to participate in social roles and activities (PROMIS - Ability to Participate in Social Roles and Activities).
Qualitative Data - In addition to measuring body image and participation, the investigators will conduct semi-structured interviews will participants to develop further understanding of the benefits and drawbacks of using the new prosthetic ankle-feet system. Participants will also complete a photovoice task in which they will be asked to take photos regarding their experience using the new prosthetic ankle-feet system. These photos will then be used as talking points during the semi-structured interview to improve the understanding of the user experience with the system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pretest-Posttest Design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: RECOVER Prosthetic Ankle-Feet SystemParticipants in this arm receive a new prosthesis system designed to improve footwear options. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RECOVER Prosthetic Ankle-Feet SystemAlso: RECOVER AFSThe 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. | Device | Intervention |
Primary outcome
Amputation-Specific Body Image Scale-Revised (ABIS-R) Change
Time frame: Baseline, 1-month, 6-months
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.
PROMIS Ability to Participate in Social Roles and Activities (PROMIS APSRA) Change
Time frame: Baseline, 1-month, 6-months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew H Hansen, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RECOVER Prosthetic Ankle-Feet System in people with Amputation, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew H Hansen, PhD ((612) 467-2910, andrew.hansen2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation-Specific Body Image Scale-Revised (ABIS-R) Change (time frame: Baseline, 1-month, 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.