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New flexible socket could make prosthetics more comfortable for Below-Knee amputees

NCT ID NCT07592325

Symptom relief Sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a new type of prosthetic socket for people with below-knee amputations. The Access Socket combines rigid carbon fiber in weight-bearing areas with flexible material in other zones, aiming to improve comfort and movement. Twenty-five adults who already use a standard rigid socket will try both types for about a month each, and researchers will measure how well they can perform daily activities.

What this could mean

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

Active substance
Access Socket (hybrid prosthetic socket with rigid carbon-fiber and flexible urethane-resin zones)
What this could lead to
If it works, this could offer a more comfortable and functional socket option for people with below-knee amputations, improving daily life and mobility.
What could go wrong
This is a small early-stage trial with only 25 people, so results may not apply to everyone. The flexible socket might not work for all residual-limb shapes or activities.

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 25 people

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

Started

Apr 2026

Expected to finish

Oct 2027

An estimate. End dates often move.

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: * Unilateral or bilateral transtibial amputation * Currently fitted with a definitive carbon rigid socket * Any residual-limb shape * Any etiology * Able to understand simple instructions, read, write, and provide informed consent - or able to be accompanied by a trusted person in case of inability to read/write autonomously * Provided free written informed consent * Aged 18 years or older * Affiliated to a social security system Exclusion Criteria: * Use of hydroalcoholic solution (HAS) for socket donning * Currently fitted with a provisional socket * Neurological pathology limiting capacity to participate in activities * Orthopedic pathology limiting capacity to participate in activities * Pregnant or breastfeeding women * Minors * Persons not under legal protection or unable to express consent * Persons under guardianship or curatorship * Persons under judicial protection

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As listed by the trial registrant

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

Lower limb amputation below knee Transtibial amputation

How to take part

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

  1. The places running it

    5 sites. 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

  • CHU Grenoble Alpes - Hôpital Sud

    RECRUITING

    Grenoble, 38434, France

  • Hôpital Filieris de Freyming-Merlebach

    RECRUITING

    Freyming-Merlebach, 57804, France

  • Hôpital National d'Instruction des Armées (HNIA) Percy

    RECRUITING

    Clamart, 92140, France

  • Insititution Nationale des Invalides

    RECRUITING

    Paris, 75007, France

  • Institut Régional de Médecine Physique et de Réadaptation (IRR) - Filière Locomoteur

    RECRUITING

    Nancy, 54000, France

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