Lower Limb AmputationNCT04275973
Evaluating Mobility Interventions in the Real World
A study testing Lower limb prostheses and Orthoses for Drop-foot in people with Lower Limb Amputation and Drop Foot, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study is intended to test the comparative biomechanical benefits of different lower-limb prostheses and orthoses using data collected over extended periods of everyday life using wearable sensors. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Amputation, Drop Foot
- What is being tested?
- Lower limb prostheses and Orthoses for Drop-foot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2021to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Target Populations:
- Participants with amputation must have used a prosthesis for more than 6 months, and wear it for at least 8 hours per day.
- Participants must be more than 6 months past their most recent surgery (if any).
- Participants must be free of musculoskeletal and cardiovascular conditions that would limit their ability to safely complete testing.
- Participants should consider themselves in good health; be able to wear their prostheses or orthoses all day long; be able to perform all of their activities of daily living (ADL) with their prostheses or orthoses as appropriate; have a comfortably fitting functional prosthesis (if applicable) that does not cause any skin problems; and have a stable residual limb (or impaired limb).
- Participants may use a narrow-base cane (single point, narrow tripod base, etc.) as an ambulatory aid but not a small-base quad cane or walker.
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- Participants must be able to walk with their prostheses or orthoses for 30 minutes (total) and stand for 30 minutes (total), in individual bouts of at least 6 minutes, without becoming fatigued, feeling dizzy, having chest pain or shortness of breath, or experiencing claudication symptoms.
- Participants involved in running tests must be able to run for 30 minutes (total) in bouts of at least 6 minutes, without becoming fatigued, feeling dizzy, having chest pain, or experiencing claudication symptoms.
- Participants must have no known cognitive disability.
- Participants must be fluent in spoken and written English.
- Running portions of the study will be limited to participants who self-report regular engagement in recreational or competitive running.
- Participants in the branch that uses only their own prostheses must have at least a daily use prosthesis and a running-specific prosthesis; additional prostheses may also be included
- Multiple Sclerosis group:
- For the specific subgroup targeting Multiple Sclerosis, participants must have a clinical diagnosis of Multiple Sclerosis and a clinician must determine they are experiencing foot drop.
- Participants must be able to comfortably wear and ambulate with both study devices with effective management of foot-drop, without significant discomfort
- Participants must be able to perform all of their activities of daily living (ADL) with only minimal use of ambulatory aids. Subjects may use a narrow-base cane (single point, narrow tripod base, etc.) as an ambulatory aid in any amount. Use of more comprehensive ambulatory aids (e.g. a small-base quad cane, wide-base quad cane or walker) must be limited to no more than 20% of their walking time when not at home. Participants who do use an assistive device occasionally should report a threshold for use of greater than 100 feet, i.e., they are unlikely to use their device unless they anticipate ambulating greater than this distance.
Who cannot join
- Target Populations:
- Allergy to electrode gel, surgical tape and metals.
- Participants who currently use the Bioness L300 Go or similar neuro-orthoses or use a carbon fiber ankle-foot orthosis at the time of the study will be excluded to avoid biasing results for one device or the other. Participants with past experience not currently using these devices will be eligible.
- Participants enrolled in physical therapy or other rehabilitative care for treatment of gait, balance, or lower extremity strength or coordination at the time of the study will be excluded to avoid confounding effects from therapy and device-based management of their condition.
- For the orthotics study, participants with peripheral neuropathy impacting control of the tibialis anterior muscle via the peroneal nerve will be excluded.
- Participants under treatment for infectious diseases will be excluded from the study.
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- Women who are pregnant or planning to become pregnant during the course of the study will be excluded.
- Symptomatic musculoskeletal conditions that prevent unaided walking, such as back pain or knee arthritis.
- Cardiovascular conditions that make moderate exercise unsafe, including (but not limited to) history of angina, peripheral vascular disease, congestive heart failure, history of myocardial infarction, and history of stroke. Potential participants will be excluded if they self-report that a physician has told them to avoid moderate exercise.
- History of chest pain, shortness of breath, or claudication symptoms during ambulation
- History of significant neuropathy with altered balance
- History of serious residual limb pain or phantom limb pain within the past six months.
- History of chronic skin breakdown.
- Inability to perform the tasks involved in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin
Madison, Wisconsin, 53706-1539
About this study
This study is intended to test the comparative biomechanical benefits of different lower-limb prostheses and orthoses using data collected over extended periods of everyday life using wearable sensors. Investigators seek to improve physical health, functional activity level, independence, workforce participation, and mental health in participants with lower limb amputation and other lower-limb impairments. Investigators seek to study the similarities and differences in participants' movement using prostheses and orthoses with different technological features or designs. Study team also seek to develop technologies that enhance the methods for using wearable sensor technology to perform this type of study.
Participants with lower-limb amputation, participants who use lower limb orthoses, and participants with drop-foot (including a specific group with Multiple Sclerosis).
- Conditions
- Lower Limb Amputation, Drop Foot
- Being tested
- Lower limb prostheses, Orthoses for Drop-foot
- Keywords
- Prostheses, Orthoses
- Medical subject headings
- Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower limb prosthesesDevice
Also called Low-profile foot, Energy-storing foot, Hydraulic ankle, Microprocessor ankle
Standard commercially available prostheses for participants with lower-limb amputation.
Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR, Agilix) feet and low-profile foot (LP, Pacifica LP), ESR feet with mobilized ankles such as passive hydraulic ankles (PHA, Kinterra), and ESR feet with microprocessor-controlled ankles (MPA, Kinnex).
Orthoses for Drop-footDevice
Also called carbon fiber ankle foot orthosis (caAFO), functional electrical stimulation (FES)
Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
Sprystep for the caAFO, Bioness L300 Go for the FES
| Study group | Role | What they receive |
|---|---|---|
| Prosthesis user with transtibial or transfemoral amputation | Experimental | Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Receives: Device: Lower limb prostheses |
| Orthoses user with drop-foot | Experimental | This arm will consists of participants with drop-foot. A subset of the drop-foot population will be persons with Multiple Sclerosis and currently drop-foot.
For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Receives: Device: Orthoses for Drop-foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum Foot Clearance With Different Prostheses
Minimum Foot Clearance with different prostheses, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.
Measured: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Minimum Foot Clearance With Different Orthoses
Minimum Foot Clearance with different orthoses, participants crossover to each of 3 different conditions at different study visits, data collected up to 20 days on study.
Measured: Baseline, 10 days, and 20 days for Orthotic interventions
Secondary outcomes (12)
Behavioral Gait Function as Measured From Daily Stride Count
Behavioral gait function will be measured by daily stride count (strides per sensor hour, Prosthetics only), participants crossed over to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.
Measured: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations
Behavioral gait function will be measured by average stride speed, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.
Measured: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Prosthetic Limb Users Survey of Mobility Score
The Prosthetic Limb Users Survey of Mobility (PLUS-M) is a 12 item questionnaire. It is a self-report instrument for measuring mobility of adults with lower limb amputation.
PLUS-M instruments measure prosthetic users' mobility (i.e., the ability to move intentionally and independently from one place to another). PLUS-M questions assess respondents' perceived ability to carry out actions that require use of both lower limbs, ranging from household ambulation to outdoor recreational activities. The described activities relate to two primary forms of movement, locomotion (i.e., movement in a continuous, repeatable pattern) and/or postural transitions (i.e., movement from one position to another or one type of activity to another).
PLUS-M instruments provide a T-score that averages 50 with a standard deviation of 10. A higher PLUS-M T-score corresponds to greater mobility.
Measured: up to 12 weeks
Change in Movement Quality as Determined by Stride Width: Prosthesis
Change in movement quality will be determined by stride width, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. Stride width is the absolute value of the lateral distance from a line that is fit to the foot placements of 3 strides previous and 3 strides after the current stride, to the foot placement location of the current stride.
Measured: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Change in Movement Quality as Determined by Stride Width: Orthoses
Change in movement quality will be determined by stride width, participants crossover to different conditions at different study visits, data collected up to 20 days on study. Stride width is the absolute value of the lateral distance from a line that is fit to the foot placements of 3 strides previous and 3 strides after the current stride, to the foot placement location of the current stride.
Measured: Baseline, 10 days, and 20 days for Orthotic interventions
Change in Gait Performance as Determined by Average Speed
Change in gait performance as determined by speed of the participant, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.
Measured: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Gait Performance as Determined by Stride Frequency at Identical Speed
Gait performance as determined by stride frequency at identical speed (included strides with walking speeds between 0.75-1.25 meters per second). Participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.
Measured: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Change in Gait Performance as Determined by Ground Reaction Forces
Ground reaction force is force applied by the body to the ground. Peak forces and shape of the force vs. time trajectory are commonly used to assess gait quality. Forces closer to "normal" are usually considered better, but this goal does not apply in participants with amputation.
Measured: Baseline, 10 days, and 20 days for Orthotic interventions, weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Change in Gait Performance as Determined by Socket Torques
Socket torque (also termed "socket moment") is the amount of twisting or bending torque applied to the prosthetic socket. Peak socket torque and cumulative socket torque are measures commonly used to assess gait quality in persons with lower limb amputation.
Measured: Baseline, 10 days, and 20 days for Orthotic interventions, weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Change in Functional Gait Assessment Score
The Functional Gait Assessment Score will be measured for the sub-population of participants with Multiple Sclerosis (MS). The total score ranges from 0-30 with higher scores indicating increased impairment in gait. Participants crossover to each of three conditions at different study visits.
Measured: Baseline, 10 days, and 20 days for Orthotic interventions
Change in 6 Minute Walking Test Distance
The sub-population of participants with MS will undergo a 6 minute walking test for distance. Each participant will crossover to three conditions over three study visits: No intervention, the carbon fiber ankle foot orthosis (cfAFO), and a functional electrical stimulation (FES) device). Reported here are the difference from No intervention for the cfAFO and FES orthoses, a positive number shows an increase in distance walked due to the intervention.
Measured: Baseline, 10 days, and 20 days study visits to test conditions for Orthotic interventions
Stride Length at Identical Walking Speed
Walking speeds from 0.75 to 1.25 meters per second were analyzed, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.
Measured: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start3 Sep 2021
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lower Limb AmputationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will perform testing inside the laboratory ("lab testing"), outside the laboratory ("field testing") on the campus of University of Wisconsin, Madison, and/or extended testing in a home and community environment ("take-home testing") to evaluate different aspects of device function. Outcomes will generally be compared using a repeated-measures design, in which each participant acts as his/her own control. This design is chosen to minimize the statistical problems caused by heterogeneity in the participant population.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Peter G Adamczyk, Ph.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275973
- Sponsor's protocol ID
- 2019-0844
- Other IDs
- A196200, ENGR/MECHANICAL ENGR/MECH ENGR, BA180043, Protocol Version 9/21/2023
- Status last verified
- Dec 2025
- First submitted
- 17 Feb 2020
- Last updated
- 19 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Mobility Interventions in the Real World
- ClinicalTrials.gov ID
- NCT04275973
- Acronym / sponsor ID
- 2019-0844
- Conditions
- Lower Limb Amputation, Drop Foot
- Keywords
- Prostheses, Orthoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Posted 19 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to test the comparative biomechanical benefits of different lower-limb prostheses and orthoses using data collected over extended periods of everyday life using wearable sensors. Investigators seek to improve physical health, functional activity level, independence, workforce participation, and mental health in participants with lower limb amputation and other lower-limb impairments. Investigators seek to study the similarities and differences in participants' movement using prostheses and orthoses with different technological features or designs. Study team also seek to develop technologies that enhance the methods for using wearable sensor technology to perform this type of study.
Participants with lower-limb amputation, participants who use lower limb orthoses, and participants with drop-foot (including a specific group with Multiple Sclerosis).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will perform testing inside the laboratory ("lab testing"), outside the laboratory ("field testing") on the campus of University of Wisconsin, Madison, and/or extended testing in a home and community environment ("take-home testing") to evaluate different aspects of device function. Outcomes will generally be compared using a repeated-measures design, in which each participant acts as his/her own control. This design is chosen to minimize the statistical problems caused by heterogeneity in the participant population.
| Arm | Type | Receives |
|---|---|---|
| Prosthesis user with transtibial or transfemoral amputation | Experimental | Device: Lower limb prosthesesExperiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). |
| Orthoses user with drop-foot | Experimental | Device: Orthoses for Drop-footThis arm will consists of participants with drop-foot. A subset of the drop-foot population will be persons with Multiple Sclerosis and currently drop-foot. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participants with amputation must have used a prosthesis for more than 6 months, and wear it for at least 8 hours per day.
- Participants must be more than 6 months past their most recent surgery (if any).
- Participants must be free of musculoskeletal and cardiovascular conditions that would limit their ability to safely complete testing.
- Participants should consider themselves in good health; be able to wear their prostheses or orthoses all day long; be able to perform all of their activities of daily living (ADL) with their prostheses or orthoses as appropriate; have a comfortably fitting functional prosthesis (if applicable) that does not cause any skin problems; and have a stable residual limb (or impaired limb).
- Participants may use a narrow-base cane (single point, narrow tripod base, etc.) as an ambulatory aid but not a small-base quad cane or walker.
Key exclusion criteria (14 listed)
- Allergy to electrode gel, surgical tape and metals.
- Participants who currently use the Bioness L300 Go or similar neuro-orthoses or use a carbon fiber ankle-foot orthosis at the time of the study will be excluded to avoid biasing results for one device or the other. Participants with past experience not currently using these devices will be eligible.
- Participants enrolled in physical therapy or other rehabilitative care for treatment of gait, balance, or lower extremity strength or coordination at the time of the study will be excluded to avoid confounding effects from therapy and device-based management of their condition.
- For the orthotics study, participants with peripheral neuropathy impacting control of the tibialis anterior muscle via the peroneal nerve will be excluded.
- Participants under treatment for infectious diseases will be excluded from the 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 |
|---|---|---|
| Lower limb prosthesesAlso: Low-profile foot, Energy-storing foot, Hydraulic ankle, Microprocessor ankleStandard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR, Agilix) feet and low-profile foot (LP, Pacifica LP), ESR feet with mobilized ankles such as passive hydraulic ankles (PHA, Kinterra), and ESR feet with microprocessor-controlled ankles (MPA, Kinnex). | Device | Prosthesis user with transtibial or transfemoral amputation |
| Orthoses for Drop-footAlso: carbon fiber ankle foot orthosis (caAFO), functional electrical stimulation (FES)Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses. Sprystep for the caAFO, Bioness L300 Go for the FES | Device | Orthoses user with drop-foot |
Primary outcome
Minimum Foot Clearance With Different Prostheses
Time frame: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Minimum Foot Clearance with different prostheses, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.
Minimum Foot Clearance With Different Orthoses
Time frame: Baseline, 10 days, and 20 days for Orthotic interventions
Minimum Foot Clearance with different orthoses, participants crossover to each of 3 different conditions at different study visits, data collected up to 20 days on study.
12 secondary outcomes
Behavioral Gait Function as Measured From Daily Stride Count
Time frame: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations
Time frame: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Prosthetic Limb Users Survey of Mobility Score
Time frame: up to 12 weeks
Change in Movement Quality as Determined by Stride Width: Prosthesis
Time frame: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Change in Movement Quality as Determined by Stride Width: Orthoses
Time frame: Baseline, 10 days, and 20 days for Orthotic interventions
Change in Gait Performance as Determined by Average Speed
Time frame: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Gait Performance as Determined by Stride Frequency at Identical Speed
Time frame: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Change in Gait Performance as Determined by Ground Reaction Forces
Time frame: Baseline, 10 days, and 20 days for Orthotic interventions, weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Change in Gait Performance as Determined by Socket Torques
Time frame: Baseline, 10 days, and 20 days for Orthotic interventions, weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Change in Functional Gait Assessment Score
Time frame: Baseline, 10 days, and 20 days for Orthotic interventions
Change in 6 Minute Walking Test Distance
Time frame: Baseline, 10 days, and 20 days study visits to test conditions for Orthotic interventions
Stride Length at Identical Walking Speed
Time frame: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Peter G Adamczyk, Ph.D. principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower limb prostheses and Orthoses for Drop-foot in people with Lower Limb Amputation and Drop Foot, run by University of Wisconsin, Madison 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 16 inclusion and 14 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: finished, as of the sponsor's last update on 19 Dec 2025. 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?
Yes. Results are posted in the registry (first posted 19 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum Foot Clearance With Different Prostheses (time frame: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on 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 19 Dec 2025.