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Nerve rerouting surgery could stop phantom limb pain

NCT ID NCT06719245

Symptom relief Sponsor: Leiden University Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a surgical technique called targeted muscle reinnervation (TMR) to prevent phantom limb pain and stump pain after a leg amputation. About 200 adults having a leg amputation due to blood vessel disease will be randomly assigned to receive either TMR or standard nerve cutting. Participants will report their pain levels and quality of life over a year to see if TMR offers better pain control.

What this could mean

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

Active substance
Targeted Muscle Reinnervation (TMR) surgical procedure
What this could lead to
If successful, TMR could become a standard surgical technique to prevent chronic pain after leg amputation, improving daily life for many patients.
What could go wrong
This is a relatively early-stage trial with 203 participants, and the sham-controlled design means some patients may not benefit. TMR is a complex surgery and may carry risks like infection or nerve damage.

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 203 people

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

Started

Dec 2024

Expected to finish

Jan 2028

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 to 75 years

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 * Patients aged between 18 and 75 years old. * Scheduled for a transtibial, through-knee, or transfemoral amputation as a primary or secondary sequela of vascular disease. Exclusion criteria * Insensate limbs at the level of amputation. * Complex Regional Pain Syndrome. * Existing neuroma or prior neuroma surgery in the affected limb. * Undergoing radiotherapy on the affected limb. * Cognitive impairment, or delirium at the time of consent. * Patients who are unfit for general anesthesia. * No nerve surgeon trained in the TMR procedure is available

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Conditions

The condition(s) this trial relates to.

neuroma peripheral vascular disease Phantom Limb

As listed by the trial registrant

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

Amputation, surgical Neuroma amputation Phantom limb pain Surgery

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

  • Alrijne Zorggroep

    NOT_YET_RECRUITING

    Leiderdorp, South Holland, 2353 GA, Netherlands

  • Amsterdam University Medical Center

    NOT_YET_RECRUITING

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Erasmus Medical Center

    NOT_YET_RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Haaglanden Medisch Centrum

    NOT_YET_RECRUITING

    The Hague, South Holland, 2512 VA, Netherlands

  • Isala Zwolle

    NOT_YET_RECRUITING

    Zwolle, Overijssel, 8025 AB, Netherlands

  • Leiden University Medical Center

    RECRUITING

    Leiden, South Holland, 2333 ZA, Netherlands

  • University Medical Center Utrecht

    NOT_YET_RECRUITING

    Utrecht, Utrecht, 3584 CX, Netherlands

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