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Can a new material make prosthetic liners last longer?

NCT ID NCT05040165

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study evaluates how long a new thermoplastic elastomer (TPE) material lasts when used in prosthetic liners and sleeves. People with below-knee amputations who already use such liners will wear the investigational device as their primary prosthesis for up to 6 months. Researchers track any material failures, like cracks or tears, through monthly online questionnaires to see if the new blend is durable enough for everyday use.

What this could mean

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

Active substance
Iceform liner and sleeve made with a new TPE material blend
What this could lead to
If the new material holds up well, it could lead to more durable prosthetic liners, reducing the need for frequent replacements.
What could go wrong
The trial is small and observational, so results may not apply to all users. The material might still fail in ways not captured during the study.

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

64 people

The number who actually took part.

Started

Dec 2019

Finished

Aug 2020

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: * Trans-tibial amputee * Uses an Iceform or Willow Wood Alpha Classic (Uniform profile) liner * Willing and able to participate in the study and follow the protocol * Confident prosthetic users for more than 3 months * Older than 18 years Exclusion Criteria: * Participating in another research study * Participants of another research study during previous 2 months.

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Conditions

The condition(s) this trial relates to.

Prosthesis Failure

As listed by the trial registrant

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

Prosthesis failure

Contacts and locations

Locations

  • ProofPilot

    New York, New York, 10003, United States

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