Lower Extremity AmputationNCT07397169
Adjustable Prosthetic Sockets for Individuals With Lower Limb Amputation
A study testing Adjustable prosthetic socket in people with Lower Extremity Amputation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Each year, around 1500 Veterans join the 623,000 Americans who live with a lower limb amputation. Many of these Veterans choose the arduous path of rehabilitation to remain ambulatory, a process that includes the prescription of a lower limb prosthesis. Much relies on the goodness of fit of their prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lower Extremity Amputation
- What is being tested?
- Adjustable prosthetic socket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans with lower limb amputation
- have a unilateral transtibial amputation
- wear a prosthesis for at least 4 hours a day by self-report
- at least one-year post-amputation
- have a modular prosthesis that includes a four-bolt socket attachment
- can walk on a treadmill
Who cannot join
- have an improper fit and suspension with their current prosthesis, and a good fit cannot be achieved with clinical resources
- have current skin irritation or injury to the residual limb, osteoarthritis, injury, or pain that interferes with walking ability
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
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
Leif A Havton, Leif.Havton@va.gov
Glenn K Klute, PhD
About this study
Official title: Adjustable Sockets for Veterans With Lower Limb Amputation: Patient Reported Outcomes and Within-socket Pressures
Each year, around 1500 Veterans join the 623,000 Americans who live with a lower limb amputation. Many of these Veterans choose the arduous path of rehabilitation to remain ambulatory, a process that includes the prescription of a lower limb prosthesis. Much relies on the goodness of fit of their prosthesis. A good fit feels comfortable and enables a variety of ambulatory activities. A poor fit results in discomfort, often accompanied by chronic skin issues, and activities of daily living are curtailed.
Conventional prosthetic sockets are custom-built by a skilled prosthetist, carefully formed to fit the Veteran's residual limb, and good fits can usually be obtained. These sockets are rigid, fixed shape structures with the robustness of a bulldozer, built for sustained, heavy-duty action. Unfortunately, the shape of an individual's residual limb can change over time, such that a good fit eventually becomes poor. One estimate suggests a new below-knee socket is needed every three and a half years. The expense of replacing sockets that no longer fit is not insignificant. Medicare expenditures for replacement of existing below-knee sockets and associated components were estimated at $50M in 2017. Importantly, Medicare is estimated to be only 20% of the market, suggesting the estimated expenditure for the entire population with lower limb amputations is likely to be meaningfully larger. A good fitting prosthesis that maintains its fit over time would serve Veterans well.
Read more
A potential solution that could make a good fit last longer is an adjustable prosthetic socket. While little evidence is available to support prescription practice, the Centers for Medicare and Medicaid Services (CMS) recently authorized reimbursement for adjustable prosthetic sockets, suggesting a compelling need for such a product.
To investigate the potential for deleterious effects and how Veterans might use adjustable prosthetic sockets, the aim of this research is to determine the pressure applied to the residual limb by an adjustable prosthetic socket during activities of varying intensity and the activities that induce adjustments.
A laboratory-based human subject experiment will be conducted using a custom sensor placed inside the adjustable panel of a study-provided adjustable prosthetic socket. Participants will acclimate to the adjustable prosthetic socket for two weeks in the field, then return to the laboratory to perform seven activities. The pressure inside the prosthesis will be measured during these activities. Participants will also report how tight their socket feels after each activity.
Read the detailed description
Prosthetic sockets enabling ambulatory mobility of Veterans with lower limb amputation are typically rigid, overly strong structural elements of fixed shape that act as the interface between the body and the environment. A Veteran's prosthetic socket is bespoke; it is meant to fit one person and one person only.
Changes in fit after the provision of a prosthesis are more common than not. Changes related to body mass, muscle atrophy, or personal fitness can happen over months while changes due to diet or diabetic complications can happen over hours. If the mismatch in shape between the residual limb and socket is small, the Veteran can manage the difference by donning or doffing residual limb socks. The approach is not ideal as some patients are more inclined to adopt the practice than others. If the mismatch in shape is large, a new prosthetic socket is usually required. Whether small or large, failure to manage changes can negatively affect their use of the prosthesis and the health of their residual limb.
Despite its limitations, the fixed-shaped prosthetic socket has been the standard-of-care for decades. However, a potentially significant event occurred in April 2024 when the Centers for Medicare and Medicaid Services (CMS) authorized reimbursement for adjustable prosthetic sockets. While the new authorization enables payment for its provision, there is little evidence to aid patients, providers, and payers in understanding the potential outcomes of prescribing an adjustable prosthetic socket.
The purpose of this research is to discover how Veterans use adjustable prosthetic sockets by measuring the pressure applied to the residual limb by an adjustable prosthetic socket during activities of varying intensity and identify what activities might induce an adjustment. The investigators will recruit ambulatory Veterans with unilateral transtibial amputations (n = 25) and fit them with an adjustable prosthetic socket.
Participants will wear an instrumented adjustable prosthetic socket after wearing a non-instrumented duplicate adjustable prosthetic socket for two weeks. Participants will be allowed to walk about for 5 to 10 minutes while the research prosthetist checks the fit and alignment of the study prosthesis. Pressure measurements will then be collected while sitting, standing, and walking. The standing and walking activities will be performed in random order, interspersed with 1-minute seated rests where the participant will release the adjustable panel pressure. The walking trials will be performed on a treadmill.
- Seated rest 5 min
- Random order with 1 min seated rest between each:
- Stand 1 min
- Walk self-selected speed 1 min
- Walk up 10% slope at self-selected speed 1 min
- Walk down 10% slope at self-selected speed 1 min
- Walk 15% faster than self-selected speed 1 min
- Walk self-selected speed 10 min Just prior to the beginning of each activity, the participant will told what the next activity is and prompted to adjust their socket accordingly. Participants will also be free to make adjustments during an activity. In this situation, the duration of the activity will be extended such that 1 minute of activity remains at the new adjustment setting. At the end of each activity, tightness will be assessed using a survey question. Specifically, after each activity, the investigators will ask each participant to rate the tightness of their adjustable prosthetic socket at the moment on a 0 to 10 scale.
In general, the investigators hypothesize that the pressure applied to the residual limb will depend on the activity, as will the tightness.
- Conditions
- Lower Extremity Amputation
- Being tested
- Adjustable prosthetic socket
- Keywords
- lower limb amputation, transtibial amputation, below knee amputation, prosthetic socket, prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustable prosthetic socketDevice
The investigators will fabricate and assemble an adjustable prosthetic socket for each participant whose shape is a duplicate of their existing, as-prescribed prosthetic socket. We will add three adjustable panels to the prosthetic socket which will be located over the medial and lateral proximal tibia region and the posterior gastrocnemius region. The position of the panels will be adjustable in and out using a cable mechanism.
| Study group | Role | What they receive |
|---|---|---|
| Adjustable prosthetic socket | Experimental | Participants will wear an adjustable prosthetic socket. Receives: Device: Adjustable prosthetic socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distal end pressure while seated (5 minute bout)
A pressure transducer will record the distal end residual limb pressure while the participant is seated for 5 minutes. The first four minutes of data will be truncated. The remaining first and last fifteen seconds of the fifth minute will also be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments
Distal end pressure while standing (1 minute bout)
A pressure transducer will record the distal end residual limb pressure while the participant stands for 1 minute. The first and last fifteen seconds will be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments
Distal end pressure while walking at self-selected speed (1 minute bout)
A pressure transducer will record the distal end residual limb pressure while the participant walks at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking up 10% slope at self-selected speed (1 minute bout)
A pressure transducer will record the distal end residual limb pressure while the participant walks up 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking down 10% slope at self-selected speed (1 minute bout)
A pressure transducer will record the distal end residual limb pressure while the participant walks down 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking 15% faster than self-selected speed (1 minute bout)
A pressure transducer will record the distal end residual limb pressure while the participant walks 15% faster than self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking at self-selected speed (10 minute bout)
A pressure transducer will record the distal end residual limb pressure while the participant walks at self-selected speed for 10 minutes. The first nine minutes of data will be truncated. The remaining first and last fifteen seconds of the tenth minute will also be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while seated (5 minute bout)
A pressure transducer will record the adjustable posterior panel pressure while the participant is seated for 5 minutes. The first four minutes of data will be truncated. The remaining first and last fifteen seconds of the fifth minute will also be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while standing (1 minute bout)
A pressure transducer will record the adjustable posterior panel pressure while the participant stands for 1 minute. The first and last fifteen seconds will be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking at self-selected speed (1 minute bout)
A pressure transducer will record the adjustable posterior panel pressure while the participant walks at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking up 10% slope at self-selected speed (1 minute bout)
A pressure transducer will record the adjustable posterior panel pressure while the participant walks up 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking down 10% slope at self-selected speed (1 minute bout)
A pressure transducer will record the adjustable posterior panel pressure while the participant walks down 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking 15% faster than self-selected speed (1 minute bout)
A pressure transducer will record the adjustable posterior panel pressure while the participant walks 15% faster than self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking at self-selected speed (10 minute bout)
A pressure transducer will record the adjustable posterior panel pressure while the participant walks at self-selected speed for 10 minutes. The first nine minutes of data will be truncated. The remaining first and last fifteen seconds of the tenth minute will also be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Secondary outcomes (7)
Tightness while seated (5 minute bout)
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while standing (1 minute bout)
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking at self-selected speed (1 minute bout)
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking up 10% slope at self-selected speed (1 minute bout)
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking down 10% slope at self-selected speed (1 minute bout)
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking 15% faster than self-selected speed (1 minute bout)
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking at self-selected speed (10 minute bout)
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
Measured: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Oct 2026 (estimated)
- Primary completion15 Jan 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 Lower Extremity 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will wear an instrumented adjustable prosthetic socket.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Glenn K Klute, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397169
- Sponsor's protocol ID
- RRD2-010-25M
- Other IDs
- 1I01RD002103-01, 1924445
- Status last verified
- Jul 2026
- First submitted
- 2 Feb 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Final data sets underlying all publications resulting from the proposed research will be shared outside VA. A de-identified, anonymized dataset will be created and available to the public via a VA authorized website. Where possible, the investigators will work with manuscript publishers to link the final study data sets as an appendix to published manuscripts. By providing de-identified datasets in open file formats (e.g., .txt, .xls, .mat) along with clearly documented instructions for processing, interested recipients will be able to reproduce and build on the same techniques which the investigators will outline in our publications. A public release identifier for each subject's data (e.g., APS\_001, APS\_002) will be created and randomly paired with de-identified study data. Data will consist of subject demographics, test, and questionnaire results. There will be no tractable way to re-match these data to the subject. Our methods will be verified by the VAPSHCS Privacy Officer.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjustable Sockets for Veterans With Lower Limb Amputation: Patient Reported Outcomes and Within-socket Pressures
- ClinicalTrials.gov ID
- NCT07397169
- Acronym / sponsor ID
- RRD2-010-25M
- Conditions
- Lower Extremity Amputation
- Keywords
- lower limb amputation, transtibial amputation, below knee amputation, prosthetic socket, prosthesis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 15 Jan 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 9 Feb 2026 (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.
Each year, around 1500 Veterans join the 623,000 Americans who live with a lower limb amputation. Many of these Veterans choose the arduous path of rehabilitation to remain ambulatory, a process that includes the prescription of a lower limb prosthesis. Much relies on the goodness of fit of their prosthesis. A good fit feels comfortable and enables a variety of ambulatory activities. A poor fit results in discomfort, often accompanied by chronic skin issues, and activities of daily living are curtailed.
Conventional prosthetic sockets are custom-built by a skilled prosthetist, carefully formed to fit the Veteran's residual limb, and good fits can usually be obtained. These sockets are rigid, fixed shape structures with the robustness of a bulldozer, built for sustained, heavy-duty action. Unfortunately, the shape of an individual's residual limb can change over time, such that a good fit eventually becomes poor. One estimate suggests a new below-knee socket is needed every three and a half years. The expense of replacing sockets that no longer fit is not insignificant. Medicare expenditures for replacement of existing below-knee sockets and associated components were estimated at $50M in 2017. Importantly, Medicare is estimated to be only 20% of the market, suggesting the estimated expenditure for the entire population with lower limb amputations is likely to be meaningfully larger. A good fitting prosthesis that maintains its fit over time would serve Veterans well.
A potential solution that could make a good fit last longer is an adjustable prosthetic socket. While little evidence is available to support prescription practice, the Centers for Medicare and Medicaid Services (CMS) recently authorized reimbursement for adjustable prosthetic sockets, suggesting a compelling need for such a product.
To investigate the potential for deleterious effects and how Veterans might use adjustable prosthetic sockets, the aim of this research is to determine the pressure applied to the residual limb by an adjustable prosthetic socket during activities of varying intensity and the activities that induce adjustments.
A laboratory-based human subject experiment will be conducted using a custom sensor placed inside the adjustable panel of a study-provided adjustable prosthetic socket. Participants will acclimate to the adjustable prosthetic socket for two weeks in the field, then return to the laboratory to perform seven activities. The pressure inside the prosthesis will be measured during these activities. Participants will also report how tight their socket feels after each activity.
Detailed description
Prosthetic sockets enabling ambulatory mobility of Veterans with lower limb amputation are typically rigid, overly strong structural elements of fixed shape that act as the interface between the body and the environment. A Veteran's prosthetic socket is bespoke; it is meant to fit one person and one person only.
Changes in fit after the provision of a prosthesis are more common than not. Changes related to body mass, muscle atrophy, or personal fitness can happen over months while changes due to diet or diabetic complications can happen over hours. If the mismatch in shape between the residual limb and socket is small, the Veteran can manage the difference by donning or doffing residual limb socks. The approach is not ideal as some patients are more inclined to adopt the practice than others. If the mismatch in shape is large, a new prosthetic socket is usually required. Whether small or large, failure to manage changes can negatively affect their use of the prosthesis and the health of their residual limb.
Despite its limitations, the fixed-shaped prosthetic socket has been the standard-of-care for decades. However, a potentially significant event occurred in April 2024 when the Centers for Medicare and Medicaid Services (CMS) authorized reimbursement for adjustable prosthetic sockets. While the new authorization enables payment for its provision, there is little evidence to aid patients, providers, and payers in understanding the potential outcomes of prescribing an adjustable prosthetic socket.
The purpose of this research is to discover how Veterans use adjustable prosthetic sockets by measuring the pressure applied to the residual limb by an adjustable prosthetic socket during activities of varying intensity and identify what activities might induce an adjustment. The investigators will recruit ambulatory Veterans with unilateral transtibial amputations (n = 25) and fit them with an adjustable prosthetic socket.
Participants will wear an instrumented adjustable prosthetic socket after wearing a non-instrumented duplicate adjustable prosthetic socket for two weeks. Participants will be allowed to walk about for 5 to 10 minutes while the research prosthetist checks the fit and alignment of the study prosthesis. Pressure measurements will then be collected while sitting, standing, and walking. The standing and walking activities will be performed in random order, interspersed with 1-minute seated rests where the participant will release the adjustable panel pressure. The walking trials will be performed on a treadmill.
- Seated rest 5 min
- Random order with 1 min seated rest between each:
- Stand 1 min
- Walk self-selected speed 1 min
- Walk up 10% slope at self-selected speed 1 min
- Walk down 10% slope at self-selected speed 1 min
- Walk 15% faster than self-selected speed 1 min
- Walk self-selected speed 10 min Just prior to the beginning of each activity, the participant will told what the next activity is and prompted to adjust their socket accordingly. Participants will also be free to make adjustments during an activity. In this situation, the duration of the activity will be extended such that 1 minute of activity remains at the new adjustment setting. At the end of each activity, tightness will be assessed using a survey question. Specifically, after each activity, the investigators will ask each participant to rate the tightness of their adjustable prosthetic socket at the moment on a 0 to 10 scale.
In general, the investigators hypothesize that the pressure applied to the residual limb will depend on the activity, as will the tightness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will wear an instrumented adjustable prosthetic socket.
| Arm | Type | Receives |
|---|---|---|
| Adjustable prosthetic socket | Experimental | Device: Adjustable prosthetic socketParticipants will wear an adjustable prosthetic socket. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Veterans with lower limb amputation
- have a unilateral transtibial amputation
- wear a prosthesis for at least 4 hours a day by self-report
- at least one-year post-amputation
- have a modular prosthesis that includes a four-bolt socket attachment
Key exclusion criteria (2 listed)
- have an improper fit and suspension with their current prosthesis, and a good fit cannot be achieved with clinical resources
- have current skin irritation or injury to the residual limb, osteoarthritis, injury, or pain that interferes with walking ability
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 |
|---|---|---|
| Adjustable prosthetic socketThe investigators will fabricate and assemble an adjustable prosthetic socket for each participant whose shape is a duplicate of their existing, as-prescribed prosthetic socket. We will add three adjustable panels to the prosthetic socket which will be located over the medial and lateral proximal tibia region and the posterior gastrocnemius region. The position of the panels will be adjustable in and out using a cable mechanism. | Device | Adjustable prosthetic socket |
Primary outcome
Distal end pressure while seated (5 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments
A pressure transducer will record the distal end residual limb pressure while the participant is seated for 5 minutes. The first four minutes of data will be truncated. The remaining first and last fifteen seconds of the fifth minute will also be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
Distal end pressure while standing (1 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments
A pressure transducer will record the distal end residual limb pressure while the participant stands for 1 minute. The first and last fifteen seconds will be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
Distal end pressure while walking at self-selected speed (1 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Distal end pressure while walking up 10% slope at self-selected speed (1 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks up 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Distal end pressure while walking down 10% slope at self-selected speed (1 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks down 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Distal end pressure while walking 15% faster than self-selected speed (1 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks 15% faster than self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Distal end pressure while walking at self-selected speed (10 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks at self-selected speed for 10 minutes. The first nine minutes of data will be truncated. The remaining first and last fifteen seconds of the tenth minute will also be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Adjustable posterior panel pressure while seated (5 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant is seated for 5 minutes. The first four minutes of data will be truncated. The remaining first and last fifteen seconds of the fifth minute will also be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
Adjustable posterior panel pressure while standing (1 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant stands for 1 minute. The first and last fifteen seconds will be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
Adjustable posterior panel pressure while walking at self-selected speed (1 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant walks at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Adjustable posterior panel pressure while walking up 10% slope at self-selected speed (1 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant walks up 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Adjustable posterior panel pressure while walking down 10% slope at self-selected speed (1 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant walks down 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Adjustable posterior panel pressure while walking 15% faster than self-selected speed (1 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant walks 15% faster than self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
Adjustable posterior panel pressure while walking at self-selected speed (10 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant walks at self-selected speed for 10 minutes. The first nine minutes of data will be truncated. The remaining first and last fifteen seconds of the tenth minute will also be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
7 secondary outcomes
Tightness while seated (5 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while standing (1 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking at self-selected speed (1 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking up 10% slope at self-selected speed (1 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking down 10% slope at self-selected speed (1 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking 15% faster than self-selected speed (1 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking at self-selected speed (10 minute bout)
Time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
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 20 Jul 2026.
- Individual participant dataSharing planned: Yes. Final data sets underlying all publications resulting from the proposed research will be shared outside VA. A de-identified, anonymized dataset will be created and available to the public via a VA authorized website. Where possible, the investigators will work with manuscript publishers to link the final study data sets as an appendix to published manuscripts. By providing de-identified datasets in open file formats (e.g., .txt, .xls, .mat) along with clearly documented instructions for processing, interested recipients will be able to reproduce and build on the same techniques which the investigators will outline in our publications. A public release identifier for each subject's data (e.g., APS_001, APS_002) will be created and randomly paired with de-identified study data. Data will consist of subject demographics, test, and questionnaire results. There will be no tractable way to re-match these data to the subject. Our methods will be verified by the VAPSHCS Privacy Officer.
Related trials for Lower Extremity Amputation
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
Impact of Footwear on Gait in Unilateral Transtibial Amputees
Transtibial Amputation, Lower Limb Amputation
Recruiting
Prosthetic Socket Fit Testing System
Amputation
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
RecruitingObservational study
Core Muscle Function and Postural Control in Lower Extremity Amputees
Amputation, Ultrasonography
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.
Glenn K Klute, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustable prosthetic socket in people with Lower Extremity 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 2 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: opening soon, as of the sponsor's last update on 20 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 Elise B Campbell, MS BFA BA ((206) 277-6792, elise.campbell@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distal end pressure while seated (5 minute bout) (time frame: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments). The study lists 14 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 20 Jul 2026.