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Freezing nerve treatment could replace surgery for stroke foot deformity

NCT ID NCT06726434

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 if a less invasive freezing technique (cryoneurotomy) works as well as surgery to reduce foot stiffness in people who had a stroke. About 114 adults with chronic foot spasticity will be randomly assigned to one of the two treatments. The goal is to see if the freezing method can ease symptoms and improve walking without the need for open surgery.

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 114 people

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

Started

Jul 2025

Expected to finish

Jun 2029

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: * Age ≥18 years old. * Patient with spastic equinovarus foot as a result of stroke in chronic phase (\>6 months). * Patient with positive perineural motor block test with or without complete correction of spastic equinus and non-persistence of 40° equinus. * Patient eligible for surgical neurotomy for varus equinus foot. * Patient presenting no cognitive impairment or major depression (Mini Mental State Examination\>20, Hospital Anxiety and Depression (HAD\<11)). * Absence of active psychosis or history of serious psychotic illness requiring hospitalization * Patient understanding and accepting the constraints of the study. * Patient covered by French national health insurance. * Patient who has given their written consent to the study after having received clear information. Exclusion Criteria: * Patient with previous nerve procedures such as chemical neurolysis with alcohol, cryoneurotomy, or any surgery at the same anatomical site. * Patient with any neurological pathology different from the one responsible for the spasticity. * Patient with botulinum toxin in lower limb injection during the last 90 days before intervention. * Patient with anti-spastic treatment (baclofene) up 3 days before block test. * Patient with total deficit of valgus muscles. * Patient with equinus foot \> 40° (retractions/ankylosis). * Surgical and anesthetic contra-indications (severe uncontrolled coagulation disorder, active infection). * Cryoneurotomy contra-indications (cold intolerance, cryoglobulinemia, cryofibrinogenemia, Raynaud's phenomena, venous thromboemolism (\< 3 months if superficial, \< 6 months if deep), hypothyreosis, cold urticari, local disorders of blood supply, considerable anemia, cachexia, hypothermia, cancer disease, infection, coagulopathy…).). * Subject requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection (temporary or permanent guardianship and, subject to subordination), and finally patients in an emergency setting. * Pregnant woman, nursing mother, woman of childbearing potential not using effective contraception (hormonal/barrier: oral, parenteral, percutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    7 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

  • C.H.U. Poitiers

    RECRUITING

    Poitiers, 86000, France

  • CHRU Montpellier

    RECRUITING

    Montpellier, 34295, France

  • CHU Rennes

    RECRUITING

    Rennes, 35000, France

  • CHU Saint-Etienne

    RECRUITING

    Saint-Etienne, 44055, France

  • Hôpital Purpan

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • Hôpital Raymond Pointcarré

    RECRUITING

    Garches, 92380, France

  • Pôle Saint-Hélier

    RECRUITING

    Rennes, 35000, France

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