AmputationNCT07266077
Influence Of A Slope Adaptive Foot On Participation Of Veterans With Lower-Limb Amputations
A study testing Fillauer Slope Adaptive Foot and Fillauer Motion Foot SLX in people with Amputation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Veterans with below-knee amputations are limited by prosthetic feet that cannot adapt to sloped and uneven terrain. This limitation results in reduced mobility, reduced balance confidence, and a higher risk of falls among some individuals who use below-knee prostheses, which have been shown to negatively impact… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Amputation
- What is being tested?
- Fillauer Slope Adaptive Foot and Fillauer Motion Foot SLX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 1 Aug 2029
- 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 willing to travel to the Minneapolis VA Health Care System
- Unilateral, below-knee amputation
- Use of a definitive prosthesis for at least 12 months (limb volume has stabilized and has accommodated to prosthesis use post-amputation)
- Medicare Functional Classification Level K3 ambulator (unlimited community ambulator)
- Well-fitting and well-aligned prosthesis
- Uses a prescribed energy storage and return foot (ESAR)
- Blessed Orientation-Memory-Concentration (Short Blessed) test score between 0-6 (no cognitive impairment)
- Access to computer, tablet, or smartphone and internet for video conferencing and REDCap data collection
Who cannot join
- Residual-limb skin problems
- Not a regular prosthesis user
- Mass over 125 kg (275 lbs)
- Residual limb too long to accommodate the study feet (104 mm of build height)
- Has used a hydraulic foot previously as part of clinical care or a research study
- Documented major neurocognitive disorder (i.e., dementia) with evidence of impact on activities of daily living and/or instrumental activities of daily living
- Baseline PROMIS-APSRA or PROMIS-SSRA 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
Sara Koehler-McNicholas, PhD MS BS, (612) 467-4017, sara.koehler@va.gov
Alexandria Lloyd, MS, (612) 467-4705, alexandria.lloyd@va.gov
About this study
Veterans with below-knee amputations are limited by prosthetic feet that cannot adapt to sloped and uneven terrain. This limitation results in reduced mobility, reduced balance confidence, and a higher risk of falls among some individuals who use below-knee prostheses, which have been shown to negatively impact participation in daily and recreational activities. The investigative group has designed a novel Slope Adaptive Foot (SAF) that is mechanically passive, capable of slope adaption on every step of walking, and maintains high levels of energy storage and return. Pilot testing of the SAF with Veterans has generated excellent results to date, with comments suggesting potential improvements in participation. This study will evaluate the extent to which participation and fall-related health outcomes are influenced by using the SAF versus a typical hydraulic foot in a cross-over randomized controlled trial. Using mixed-methods, the investigators will also collect long-term data of Veterans using their preferred foot to inform the development of evidence-based education materials for use in clinical decision making.
Read the detailed description
Background and Relevance to VA - Over 90% of Veterans who use a below-knee prosthesis in the community are prescribed an energy storage and return (ESAR) foot. ESAR feet are designed to assist with forward propulsion during walking, which many users find helpful for certain activities. However, ESAR feet lack ankle articulation, making it difficult to walk on non-level surfaces. To overcome this limitation, typical hydraulic feet incorporate damped ankle motion to accommodate walking on uneven terrain. While potentially improving aspects of participation and fall-related health, typical hydraulic feet have reduced energy storage and return compared to ESAR feet.
To combine the benefits of ESAR and typical hydraulic feet, the Minneapolis VA, in collaboration with Fillauer Motion Control, Inc., has developed a novel hydraulic Slope Adaptive Foot (SAF). During pilot testing, most Veterans preferred the SAF over their prescribed ESAR foot and reported improvements in participation. Further research is needed to evaluate the impact of different prosthetic feet on participation and fall-related health in order to identify which patients are best suited for an ESAR foot, a typical hydraulic foot, or the SAF.
Innovation and Impact - The long-term goal of this project is to inform prescription of hydraulic feet for Veterans living with lower-limb amputation to optimize their participation in important life roles and activities. Results of this study will help to develop evidence-based provider training and patient education materials to assist with precision rehabilitation and a patient-centered care approach to prescribing hydraulic prosthetic feet.
Aim 1 - Evaluate the influence of different prosthetic foot-related factors on participation. PROMIS Ability to Participate in Social Roles and Activities (APSRA) and PROMIS Satisfaction with Social Roles and Activities (SSRA) will be administered during a cross-over randomized control trial (RCT). This aim will test the hypothesis that using the SAF will be associated with greater PROMIS-APSRA and/or PROMIS-SSRA scores relative to a typical hydraulic foot and that using either hydraulic foot will be associated with greater PROMIS-APSRA and/or PROMIS-SSRA scores compared to the ESAR foot.
Aim 2 - Characterize the lived experiences of Veterans using their preferred prosthetic foot to inform clinical decision making. Mixed-methods will be used to explore how participation in social roles and activities is influenced by hydraulic and ESAR feet. Gaining a deeper understanding of Veterans' experiences across a range of situations and environments will inform the development of evidence-based education materials.
Exploratory Aim - Evaluate the influence of different prosthetic foot-related factors on fall-related health outcomes. The Prosthetic Limb Users Survey of Fall-Related Health (PLUS-FRH), which includes four distinct and important domains, will be administered during a cross-over RCT. This aim will test the hypothesis that using the SAF will be associated with improved fall-related health outcomes relative to a typical hydraulic foot and that using either hydraulic foot will be associated with improved fall-related health outcomes compared to the ESAR foot.
Methodology - To address these aims, this study will 1) conduct a cross-over RCT of the SAF versus a typical hydraulic foot (Motion Foot SLX, Fillauer) among 30 Veterans with a below-knee amputation who use an ESAR foot and have no prior experience with a hydraulic foot, and 2) conduct a one-year observational study in which Veterans use their preferred prosthetic foot. Participants will complete quantitative (PROMIS-APSRA, PROMIS-SSRA, PLUS-FRH) and qualitative (semi-structured interviews) assessments at baseline and after each period of the cross-over RCT and quarterly during the one-year observational study. A participatory method will be used in which Veterans will be asked to share photos with a short narrative to portray their experiences with their preferred prosthetic foot to prompt discussion during the quarterly interviews of the one-year observational study.
Participating Sites - Minneapolis VA Health Care System (data collection site) and the University of Washington.
Duration of Participant Intake (Study Duration) - This project is projected to occur over four years. The project will begin with a 3-month start-up period and recruitment will continue for 18 months following start-up. Data collection will conclude with 9 months remaining in the study timeline, which will be used for data analysis, dissemination, development of implementation materials, and study closure.
Path to Implementation - Data gathered from this study will be used to draft evidence-based education materials for providers and Veterans. These materials, which will provide pertinent and useful information about foot options (ESAR, SLX, SAF) for prosthetic prescription, will be used in a future implementation study.
- Conditions
- Amputation
- Being tested
- Fillauer Slope Adaptive Foot, Fillauer Motion Foot SLX
- Keywords
- Artificial Limbs, Amputation, Leg Prosthesis, Ankle, Community Participation, Social Participation, Falls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fillauer Slope Adaptive FootDevice
Also called SAF
The SAF uses an articulated ankle and damped plantarflexion to accommodate slopes and uneven terrain. It locks when the forefoot reaches the ground at the beginning of stance phase, which allows the SAF to re-align, or adapt, to the walking surface. After the SAF locks, the laminated foot plate can deflect and store energy as dorsiflexion occurs, returning that energy to the user in late stance for forward propulsion. Finally, at the end of stance phase, when the toe leaves the ground, the SAF unlocks and actively dorsiflexes the ankle to increase toe clearance during swing.
Fillauer Motion Foot SLXDevice
Also called SLX
The SLX is an articulated, hydraulic ankle that provides passive ankle motion through damped plantarflexion and dorsiflexion to facilitate slope accommodation.
| Study group | Role | What they receive |
|---|---|---|
| SAF-SLX | Experimental | Participants in this arm will start the cross-over randomized controlled trial with the SAF. After a four-week take-home period with the SAF, participants will return to their usual prosthetic foot for a four-week washout period. They will then be fit with the SLX for a four-week take-home period. Receives: Device: Fillauer Slope Adaptive Foot; Device: Fillauer Motion Foot SLX |
| SLX-SAF | Experimental | Participants in this arm will start the cross-over randomized controlled trial with the SLX. After a four-week take-home period with the SLX, participants will return to their usual prosthetic foot for a four-week washout period. They will then be fit with the SAF for a four-week take-home period. Receives: Device: Fillauer Slope Adaptive Foot; Device: Fillauer Motion Foot SLX |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Ability to Participate in Social Roles and Activities (APSRA)
This Patient Reported Outcome Measurement Information System (PROMIS) short form is an 8-item self-report survey instrument, developed from PROMIS item banks, that provides T scores (mean = 50, SD = 10) based on a normative sample from a general population of healthy US adults. The PROMIS-APSRA specifically measures the frequency with which one has trouble with completing or needs to limit participation in social roles and activities, including leisure activities and activities with friends and family. This PROMIS measure uses a 5-point ordinal response scale, where higher values indicate a higher degree of ability to participate.
Measured: Day 1 of the RCT, after each 4-week intervention in the RCT, and 13 weeks, 26 weeks, 39 weeks, and 52 weeks into the 1-year observational period of the study
PROMIS Satisfaction with Social Roles and Activities (SSRA)
This Patient Reported Outcome Measurement Information System (PROMIS) short form is an 8-item self-report survey instrument, developed from PROMIS item banks, that provides T scores (mean = 50, SD = 10) based on a normative sample from a general population of healthy US adults. The PROMIS-SSRA measures the level of satisfaction with one's ability to participate in recreational activities, activities of daily living, and to meet the needs of friends and family. This PROMIS measure uses a 5-point ordinal response scale, where higher values indicate a higher degree of satisfaction with participation.
Measured: Day 1 of the RCT, after each 4-week intervention in the RCT, and 13 weeks, 26 weeks, 39 weeks, and 52 weeks into the 1-year observational period of the study
Secondary outcomes (1)
Prosthetic Limb Users Survey of Fall-Related Health (PLUS-FRH)
Each domain of the PLUS-FRH (fall-related self-efficacy, anxiety, avoidance behavior, and interference) corresponds to a 15-item instrument that provides T scores (mean = 50, SD = 10) based on a normative sample of lower-limb prosthesis users. The items on the PLUS-FRH use a 5-point ordinal response scale, where higher values correspond to better or worse fall-related health outcomes, depending on the domain.
Measured: Day 1 of the RCT, after each 4-week intervention in the RCT, and 13 weeks, 26 weeks, 39 weeks, and 52 weeks into the 1-year observational period of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Jul 2026
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2029 (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
- Randomised
- Intervention model
- Crossover
- Model description
- This study includes two distinct phases. The first is a cross-over randomized controlled trial (RCT) with a four-week take-home period to test two hydraulic foot types: the SAF and a typical hydraulic foot (Fillauer Motion Foot SLX). The second phase of this study is a one-year observational period of the Veteran's preferred foot (ESAR, SAF, or SLX).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Sara Koehler-McNicholas, PhD MS BS, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MNMary E Matsumoto, MD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266077
- Sponsor's protocol ID
- RRD4-004-24W
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2025
- Last updated
- 30 Jul 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence Of A Slope Adaptive Foot On Participation Of Veterans With Lower-Limb Amputations
- ClinicalTrials.gov ID
- NCT07266077
- Acronym / sponsor ID
- RRD4-004-24W
- Conditions
- Amputation
- Keywords
- Artificial Limbs, Amputation, Leg Prosthesis, Ankle, Community Participation, Social Participation, Falls
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Washington
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 5 Dec 2025 (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 below-knee amputations are limited by prosthetic feet that cannot adapt to sloped and uneven terrain. This limitation results in reduced mobility, reduced balance confidence, and a higher risk of falls among some individuals who use below-knee prostheses, which have been shown to negatively impact participation in daily and recreational activities. The investigative group has designed a novel Slope Adaptive Foot (SAF) that is mechanically passive, capable of slope adaption on every step of walking, and maintains high levels of energy storage and return. Pilot testing of the SAF with Veterans has generated excellent results to date, with comments suggesting potential improvements in participation. This study will evaluate the extent to which participation and fall-related health outcomes are influenced by using the SAF versus a typical hydraulic foot in a cross-over randomized controlled trial. Using mixed-methods, the investigators will also collect long-term data of Veterans using their preferred foot to inform the development of evidence-based education materials for use in clinical decision making.
Detailed description
Background and Relevance to VA - Over 90% of Veterans who use a below-knee prosthesis in the community are prescribed an energy storage and return (ESAR) foot. ESAR feet are designed to assist with forward propulsion during walking, which many users find helpful for certain activities. However, ESAR feet lack ankle articulation, making it difficult to walk on non-level surfaces. To overcome this limitation, typical hydraulic feet incorporate damped ankle motion to accommodate walking on uneven terrain. While potentially improving aspects of participation and fall-related health, typical hydraulic feet have reduced energy storage and return compared to ESAR feet.
To combine the benefits of ESAR and typical hydraulic feet, the Minneapolis VA, in collaboration with Fillauer Motion Control, Inc., has developed a novel hydraulic Slope Adaptive Foot (SAF). During pilot testing, most Veterans preferred the SAF over their prescribed ESAR foot and reported improvements in participation. Further research is needed to evaluate the impact of different prosthetic feet on participation and fall-related health in order to identify which patients are best suited for an ESAR foot, a typical hydraulic foot, or the SAF.
Innovation and Impact - The long-term goal of this project is to inform prescription of hydraulic feet for Veterans living with lower-limb amputation to optimize their participation in important life roles and activities. Results of this study will help to develop evidence-based provider training and patient education materials to assist with precision rehabilitation and a patient-centered care approach to prescribing hydraulic prosthetic feet.
Aim 1 - Evaluate the influence of different prosthetic foot-related factors on participation. PROMIS Ability to Participate in Social Roles and Activities (APSRA) and PROMIS Satisfaction with Social Roles and Activities (SSRA) will be administered during a cross-over randomized control trial (RCT). This aim will test the hypothesis that using the SAF will be associated with greater PROMIS-APSRA and/or PROMIS-SSRA scores relative to a typical hydraulic foot and that using either hydraulic foot will be associated with greater PROMIS-APSRA and/or PROMIS-SSRA scores compared to the ESAR foot.
Aim 2 - Characterize the lived experiences of Veterans using their preferred prosthetic foot to inform clinical decision making. Mixed-methods will be used to explore how participation in social roles and activities is influenced by hydraulic and ESAR feet. Gaining a deeper understanding of Veterans' experiences across a range of situations and environments will inform the development of evidence-based education materials.
Exploratory Aim - Evaluate the influence of different prosthetic foot-related factors on fall-related health outcomes. The Prosthetic Limb Users Survey of Fall-Related Health (PLUS-FRH), which includes four distinct and important domains, will be administered during a cross-over RCT. This aim will test the hypothesis that using the SAF will be associated with improved fall-related health outcomes relative to a typical hydraulic foot and that using either hydraulic foot will be associated with improved fall-related health outcomes compared to the ESAR foot.
Methodology - To address these aims, this study will 1) conduct a cross-over RCT of the SAF versus a typical hydraulic foot (Motion Foot SLX, Fillauer) among 30 Veterans with a below-knee amputation who use an ESAR foot and have no prior experience with a hydraulic foot, and 2) conduct a one-year observational study in which Veterans use their preferred prosthetic foot. Participants will complete quantitative (PROMIS-APSRA, PROMIS-SSRA, PLUS-FRH) and qualitative (semi-structured interviews) assessments at baseline and after each period of the cross-over RCT and quarterly during the one-year observational study. A participatory method will be used in which Veterans will be asked to share photos with a short narrative to portray their experiences with their preferred prosthetic foot to prompt discussion during the quarterly interviews of the one-year observational study.
Participating Sites - Minneapolis VA Health Care System (data collection site) and the University of Washington.
Duration of Participant Intake (Study Duration) - This project is projected to occur over four years. The project will begin with a 3-month start-up period and recruitment will continue for 18 months following start-up. Data collection will conclude with 9 months remaining in the study timeline, which will be used for data analysis, dissemination, development of implementation materials, and study closure.
Path to Implementation - Data gathered from this study will be used to draft evidence-based education materials for providers and Veterans. These materials, which will provide pertinent and useful information about foot options (ESAR, SLX, SAF) for prosthetic prescription, will be used in a future implementation study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study includes two distinct phases. The first is a cross-over randomized controlled trial (RCT) with a four-week take-home period to test two hydraulic foot types: the SAF and a typical hydraulic foot (Fillauer Motion Foot SLX). The second phase of this study is a one-year observational period of the Veteran's preferred foot (ESAR, SAF, or SLX).
| Arm | Type | Receives |
|---|---|---|
| SAF-SLX | Experimental | Device: Fillauer Slope Adaptive Foot, Device: Fillauer Motion Foot SLXParticipants in this arm will start the cross-over randomized controlled trial with the SAF. After a four-week take-home period with the SAF, participants will return to their usual prosthetic foot for a four-week washout period. They will then be fit with the SLX for a four-week take-home period. |
| SLX-SAF | Experimental | Device: Fillauer Slope Adaptive Foot, Device: Fillauer Motion Foot SLXParticipants in this arm will start the cross-over randomized controlled trial with the SLX. After a four-week take-home period with the SLX, participants will return to their usual prosthetic foot for a four-week washout period. They will then be fit with the SAF for a four-week take-home period. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- US military Veterans willing to travel to the Minneapolis VA Health Care System
- Unilateral, below-knee amputation
- Use of a definitive prosthesis for at least 12 months (limb volume has stabilized and has accommodated to prosthesis use post-amputation)
- Medicare Functional Classification Level K3 ambulator (unlimited community ambulator)
- Well-fitting and well-aligned prosthesis
Key exclusion criteria (7 listed)
- Residual-limb skin problems
- Not a regular prosthesis user
- Mass over 125 kg (275 lbs)
- Residual limb too long to accommodate the study feet (104 mm of build height)
- Has used a hydraulic foot previously as part of clinical care or a research study
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 |
|---|---|---|
| Fillauer Slope Adaptive FootAlso: SAFThe SAF uses an articulated ankle and damped plantarflexion to accommodate slopes and uneven terrain. It locks when the forefoot reaches the ground at the beginning of stance phase, which allows the SAF to re-align, or adapt, to the walking surface. After the SAF locks, the laminated foot plate can deflect and store energy as dorsiflexion occurs, returning that energy to the user in late stance for forward propulsion. Finally, at the end of stance phase, when the toe leaves the ground, the SAF unlocks and actively dorsiflexes the ankle to increase toe clearance during swing. | Device | SAF-SLX, SLX-SAF |
| Fillauer Motion Foot SLXAlso: SLXThe SLX is an articulated, hydraulic ankle that provides passive ankle motion through damped plantarflexion and dorsiflexion to facilitate slope accommodation. | Device | SAF-SLX, SLX-SAF |
Primary outcome
PROMIS Ability to Participate in Social Roles and Activities (APSRA)
Time frame: Day 1 of the RCT, after each 4-week intervention in the RCT, and 13 weeks, 26 weeks, 39 weeks, and 52 weeks into the 1-year observational period of the study
This Patient Reported Outcome Measurement Information System (PROMIS) short form is an 8-item self-report survey instrument, developed from PROMIS item banks, that provides T scores (mean = 50, SD = 10) based on a normative sample from a general population of healthy US adults. The PROMIS-APSRA specifically measures the frequency with which one has trouble with completing or needs to limit participation in social roles and activities, including leisure activities and activities with friends and family. This PROMIS measure uses a 5-point ordinal response scale, where higher values indicate a higher degree of ability to participate.
PROMIS Satisfaction with Social Roles and Activities (SSRA)
Time frame: Day 1 of the RCT, after each 4-week intervention in the RCT, and 13 weeks, 26 weeks, 39 weeks, and 52 weeks into the 1-year observational period of the study
This Patient Reported Outcome Measurement Information System (PROMIS) short form is an 8-item self-report survey instrument, developed from PROMIS item banks, that provides T scores (mean = 50, SD = 10) based on a normative sample from a general population of healthy US adults. The PROMIS-SSRA measures the level of satisfaction with one's ability to participate in recreational activities, activities of daily living, and to meet the needs of friends and family. This PROMIS measure uses a 5-point ordinal response scale, where higher values indicate a higher degree of satisfaction with participation.
1 secondary outcome
Prosthetic Limb Users Survey of Fall-Related Health (PLUS-FRH)
Time frame: Day 1 of the RCT, after each 4-week intervention in the RCT, and 13 weeks, 26 weeks, 39 weeks, and 52 weeks into the 1-year observational period of the study
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 30 Jul 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.
Sara Koehler-McNicholas, PhD MS BS principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
Mary E Matsumoto, MD 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 Fillauer Slope Adaptive Foot and Fillauer Motion Foot SLX 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 8 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 30 Jul 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 Sara Koehler-McNicholas, PhD MS BS ((612) 467-4017, sara.koehler@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Ability to Participate in Social Roles and Activities (APSRA) (time frame: Day 1 of the RCT, after each 4-week intervention in the RCT, and 13 weeks, 26 weeks, 39 weeks, and 52 weeks into the 1-year observational period of the study). 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 30 Jul 2026.