Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New socket design aims to boost comfort for amputees

NCT ID NCT05662982

Symptom relief Sponsor: University of Washington Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new type of prosthetic socket called the NU-FlexSIS for people who have a leg amputation above the knee and have limited mobility. The goal was to see if this socket is more comfortable and allows more wear time than the standard socket. 84 participants used both sockets so researchers could compare comfort, mobility, and quality of life.

What this could mean

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

Active substance
Northwestern University Flexible Subischial Suction Socket (NU-FlexSIS) - a custom prosthetic socket
What this could lead to
If successful, this socket could offer a more comfortable and functional option for people with lower mobility levels who have a leg amputation.
What could go wrong
This is a completed trial with 84 participants, so results are limited to this specific group. The socket may not work for everyone, and comfort improvements may vary.

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

84 people

The number who actually took part.

Started

Mar 2023

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

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: 1. Speak and read English; 2. Provision of signed and dated informed consent form; 3. Stated willingness to comply with all study procedures and availability for the duration of the study; 4. All sexes and genders age 18 years and older; 5. Have a unilateral transfemoral or knee disarticulation amputation and have used a prosthesis for 1 year or more; 6. Be classified by their prosthetist as being a Medicare Functional Classification Level of K2 (limited community ambulator); 7. Have never worn a sub-ischial socket; 8. Current IC socket and prosthesis must be well fitting and maintained; current socket must have pelvic weightbearing and/or containment; 9. Participant has no plans to change the knee or foot in the next 10 months; 10. Willingness to adhere to the monitoring and new socket regimen; 11. Have sufficient upper limb function to don liner and change sensors; 12. Access to necessary resources for participating in the study (i.e., computer, smartphone, internet access, telephone): 13. Be a Veteran (VA site only). Exclusion Criteria (intervention group only): 1. Have a femoral length \<5 inches; 2. Have a known silicone allergy; 3. Are unable to don or tolerate wearing a compressive liner; 4. Loss of metatarsal heads on contralateral limb; 5. Active malignancy; 6. Pregnancy; 7. Polytrauma that affects functional ability beyond that of a unilateral transfemoral amputation.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Transfemoral amputation are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

As listed by the trial registrant

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

Transfemoral amputation

Contacts and locations

Locations

  • Hanger Institute for Clinical Research and Education

    Houston, Texas, 78758, United States

  • Minneapolis VA Health Care System

    Minneapolis, Minnesota, 55417, United States

  • University of Washington

    Seattle, Washington, 98195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.