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Veterans study aims to match prosthetic feet to individual needs

NCT ID NCT03505983

Knowledge-focused Sponsor: VA New York Harbor Healthcare System Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how to choose the right prosthetic foot for veterans and service members who have lost a leg below the knee. Researchers will test different types of energy-storing prosthetic feet to see which ones help people walk better, climb stairs, and move more easily. The goal is to create clear guidelines so doctors can prescribe the best foot for each person's needs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

91 people

The number who actually took part.

Started

Mar 2018

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * DEERS eligible Veteran or Service Member, or civilian with unilateral transtibial amputation * Currently using an Energy Storing and Returning prosthetic foot with a well-fitting socket as a primary or back-up prosthesis * Achieved a "Modified Independence" score on the Functional Independence Measure (FIM) for the locomotion mobility items * Has a minimum clearance of 8 ¾ inches to accommodate all feet Exclusion Criteria: * Has active wounds/ulcers or significant musculoskeletal comorbidities on their intact limb that would impair their ability to participate in all functional outcome measures * Has any comorbidity that results in rapid limb volume changes (i.e. end stage renal disease with dialysis), * Weighs more than 275 pounds, the maximum product weight load * Is unable or unwilling to comply with all research visits * Has cognitive deficit(s) or mental health pathology limiting a subject's ability to participate fully in the study * Women who are pregnant or plan to become pregnant during study activities. This will be determined by asking the participant if they are pregnant or if they believe that they may be pregnant. This question will only be asked at inclusion, as biomechanical changes will only be impacted if the woman is in the 2nd or 3rd trimester, and will not be impacted if the participant becomes pregnant while in the study. * Poorly fitting socket * Vision loss that requires use of an assistive device for gait * Upper Limb Amputation

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amputation; traumatic, limb, lower Prosthesis user

Contacts and locations

Locations

  • VA New York Harbor Healthcare System

    New York, New York, 10010, United States

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