Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a breathable liner stop the sweat inside a prosthetic leg?

NCT ID NCT04787484

Symptom relief Sponsor: Össur Iceland ehf 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests a new type of prosthetic liner that lets moisture escape, aiming to reduce the sweating and heat that often build up inside a traditional airtight liner. Adults with above-knee amputations who already use a direct socket will wear the breathable liner and socket for 12 weeks. Researchers will compare their experiences with a standard silicone liner, focusing on comfort, how securely the prosthetic stays attached, and skin health.

What this could mean

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

Active substance
A breathable prosthetic liner and socket system designed to reduce skin moisture and improve comfort for people with above-knee amputations.
What this could lead to
If it works, this could lead to a more comfortable prosthetic option that reduces sweating and improves skin health for amputees.
What could go wrong
This is a small early-stage study with only 18 participants, so results may not apply to everyone. The new liner must also prove it holds the prosthetic securely, not just that it feels cooler.

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.

Participants

18 people

The number who actually took part.

Started

Oct 2020

Finished

Nov 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * 50Kg\< body weight \< 136Kg * Cognitive ability to understand all instructions and questionnaires in the study * Unilateral/bilateral trans-femoral amputees * Activity level: high K2-K4 * Liner: Össur Seal-In TF silicone liner * Socket: All subjects shall be using Direct Socket, and have been for minimum 4 weeks * Willing and able to participate in the study and follow the protocol * Confident prosthetic users for more than 3 months * Older than 18 years * Residual limb profile: Standard or conical. At least 30% of subjects must be either conical or standard. * Subgroup: Minimum 10 subjects shall fit inclusion for subgroup of amputees with history of skin issues. Exclusion Criteria: * 50Kg\> body weight \> 136Kg * Users with cognitive impairment * Participating in another research study

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Prostheses and implants are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

As listed by the trial registrant

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

Prostheses and implants

More trials for these conditions

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