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New 3D-Printed feet could let women vets wear any shoes

NCT ID NCT05601869

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new prosthetic foot system for women veterans with below-knee amputations. The device uses 3D-printed feet that can be swapped to fit different shoes, giving users more footwear options. Researchers want to see if this improves body image and social participation. The study will enroll 18 women veterans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RECOVER Prosthetic Ankle-Feet System (a prosthetic device with 3D-printed feet for different shoes)
What this could lead to
If successful, this could help women veterans with amputations feel better about their body image and participate more in social activities by allowing them to wear a wider variety of shoes.
What could go wrong
This is a very small early study with only 18 participants, so results may not apply to all veterans. The device may not fit well or could cause skin problems.

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

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Mar 2027

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 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * US military Veterans that identify as women * Transtibial (below-knee) amputation * Using a definitive prosthesis for at least 6 months (limb has accommodated to prosthesis use post-amputation) * Well fitting and well aligned prosthesis * Blessed Orientation-Memory-Concentration (Short Blessed) score between 0-6 * Access to computer, tablet, or smart phone and internet for video conferencing and RedCap data collection Exclusion Criteria: * Residual limb skin problems * Residual limb too long to accommodate the RECOVER prosthetic ankle-feet system * Unable or unwilling to travel to Minneapolis * Not a regular prosthesis user * Mass over 125 kg * Documented neurocognitive disorder (e.g., dementia) with evidence of impact on activities of daily living and/or instrumental activities of daily living * Baseline ABIS-R or PROMIS-APSRA scores at the maximum levels (no room for improvement on primary outcomes)

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As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Minneapolis VA Health Care System, Minneapolis, MN

    RECRUITING

    Minneapolis, Minnesota, 55417-2309, United States

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