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 prosthetic foot aims to boost mobility for amputees

NCT ID NCT06627361

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a new prosthetic foot called the Pro-Flex Pivot helps people with below-knee amputations move better than a standard energy-storing foot. Thirty adults who already use a standard foot wore each type for four weeks and reported their mobility and comfort. The goal is to see if the new design, which has a more flexible ankle and carbon blades, improves walking 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
Pro-Flex Pivot prosthetic foot
What this could lead to
If successful, this foot could offer better mobility and comfort for people with below-knee amputations compared to current standard feet.
What could go wrong
This is a small, completed study with only 30 participants, so results may not apply to everyone. The improvement may be modest or not noticeable in daily life.

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

30 people

The number who actually took part.

Started

Nov 2023

Finished

May 2025

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: Adult patient (over 18 years of age) * Unilateral tibial amputee and fitted for at least 6 months with a class III ESAR foot. * Regularly using (more than 8 hours/day) a class III ESAR foot * Functional class (CNEDiMTS indication)1 * Insured person. * Able to answer questionnaires. * Providing informed and written consent to participate in the study. * Having a normalized PLUS-M/FC 12 score less than 50 for vascular amputee and 55 for traumatic amputee and other causes of amputation. * Experiencing no discomfort related to the socket indicated by a score ≥ 6 on the numerical scale from 0 to 10 (Socket Comfort Score) Exclusion Criteria: * Bilateral lower limb amputation * Femoral amputation * Wearing a temporary prosthesis * Change of socket or suspension system planned during the study. * Change of any functional component as torsion or choc adapter * Significant change in the patient's routine activities expected during the study. * Progressive associated pathology that may prevent patient follow-up. * Associated pathology that may limit the patient's mobility (e.g. disarticulation of the knee, knee pain... ) * No osteointegration patients * Lack of consent * Adult subject to enhanced protection, deprived of liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social institution for purposes other than research. * Person not affiliated with or a beneficiary of a health insurance plan. * Patient unable to understand the study instructions

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for 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.

Amputation

Contacts and locations

Locations

  • Multiples locations

    Multiple Locations, France

More trials for these conditions

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