Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation (SocketFit)

April 20, 2026 updated by: VA Office of Research and Development

Improving Socket Fit in Female and Male Veterans With Transtibial and TransfemoralAmputation

The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of the project is to determine the effects of using different prosthetic socket designs with the same suspension and components on the biomechanical asymmetry, residual limb movement within the socket (socket pistoning) and comfort/satisfaction of 20 Veterans with a transtibial amputation and 20 Veterans with a transfemoral amputation, 10 males and 10 females per group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045-7211
        • Recruiting
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
        • Contact:
        • Principal Investigator:
          • Alena Grabowski, PhD BA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

20 Veterans with unilateral transtibial amputation and 20 Veterans with unilateral transfemoral amputation

Description

Inclusion Criteria:

  • The investigators will enroll up to 40 Veterans

    • 20 with unilateral transtibial amputation
    • 20 with unilateral transfemoral amputation who are at or above a K2 Medicare functional classification level (MFCL) and who are 18-65 years old
  • All participants will have no current problems with their prosthesis or residual limb, and be at least 6-months post-amputation
  • Participants will be at or above a K2 MFCL, defined as a person who has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces, typical of the limited community ambulator

Exclusion Criteria:

  • Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Veterans with a transtibial amputation
20 Veterans with a transtibial amputation, 10 females and 10 males
Device: Conventional prosthetic socket
Participants will use their own conventional rigid socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for ~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.
Device: Adjustable Quatro socket
Participants will use an adjustable Quatro socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for ~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.
Veterans with a transfemoral amputation
20 Veterans with a transfemoral amputation, 10 females and 10 males
Device: Conventional prosthetic socket
Participants will use their own conventional rigid socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for ~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.
Device: Adjustable Quatro socket
Participants will use an adjustable Quatro socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for ~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biomechanical Asymmetry
Time Frame: through study completion, an average of 4 years
The assessments of ground reaction forces, and joint motion, torque, power, and work will be aggregated into a measure of asymmetry that compares the percentage difference between the affected and unaffected legs of each participant. The investigators will compare asymmetry between groups and sockets.
through study completion, an average of 4 years
Prosthetic Evaluation Questionnaire
Time Frame: through study completion, an average of 4 years
The prosthetic evaluation questionnaire assesses comfort and satisfaction. This questionnaire asks participants to rate their comfort and satisfaction based on a 10-point scale and contains 54 questions organized into 9 domain scales, where each scale can be used to independently measure a domain. The investigators will compare overall and domain-specific scores between groups and sockets.
through study completion, an average of 4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Socket pistoning
Time Frame: through study completion, an average of 4 years
Movement of the residual limb within the socket. The investigators will compared socket pistoning between groups and sockets.
through study completion, an average of 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alena Grabowski, PhD BA, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3643-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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