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Could extra support before and after amputation improve recovery?

NCT ID NCT04750876

Symptom relief Sponsor: Centre Hospitalier Departemental Vendee 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing whether adding a psychologist and a physical therapist to the usual care of people having a leg amputation can improve their physical and emotional recovery. About 40 adults who need a lower-leg amputation due to poor blood flow will be randomly assigned to either standard care or extra support from these specialists. The main goal is to see if the extra care leads to better mobility and fewer emotional problems 10 days after surgery.

What this could mean

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

Active substance
psychological counseling and physical therapy
What this could lead to
If it works, this could show that adding mental health and physical therapy support helps amputees recover better and feel less distressed.
What could go wrong
This is a small, early-stage study with only 40 participants, so results may not apply to everyone. It also does not test a drug or device, so any benefit is about improving care routines, not a medical breakthrough.

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 40 people

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

Started

Apr 2021

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: * Patient over the age of majority, no age limit * Amputation related to obliterative arteriopathy of the lower limbs * Trans-tibial or trans-femoral amputation * Patient with an indication of discharge to a rehabilitation and re-education service * Patient with the ability to understand the protocol * Patient who has agreed to participate in the study and has given express oral consent * Patient receiving social security cover or entitled to it Exclusion Criteria: * Trauma related amputation * Amputation of upper limb, trans-metatarsal or one or more toes * Amputation of comfort in a palliative care setting * Patient leaving home after surgery * Patient undergoing psychological or psychiatric treatment * Pregnant or breastfeeding woman, or a woman who is able to procreate without effective contraception * Patient unable to follow the protocol as judged by the investigator * Patient participating in another interventional research protocol involving a drug or medical device * Patient under guardianship, curators or legal protection measure

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As listed by the trial registrant

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

Amputation

How to take part

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

  1. The places running it

    1 site. 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

  • Departmental Hospital Centre - Vendee

    RECRUITING

    La Roche-sur-Yon, France

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