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Could a muscle graft stop phantom limb pain?

NCT ID NCT07420192

Symptom relief Sponsor: Saglik Bilimleri Universitesi 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a surgery called RPNI can reduce nerve pain in people who have had a leg amputated. The surgery takes the cut nerve end and wraps it in a small piece of the patient's own muscle to help it heal. Researchers will follow 20 adults for 24 months to see if pain, movement, and satisfaction with their prosthetic improve.

What this could mean

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

Active substance
Regenerative Peripheral Nerve Interface (RPNI) surgery
What this could lead to
If successful, this could offer a surgical option to reduce chronic nerve pain and improve mobility for people with lower-limb amputations.
What could go wrong
This is a small, early-stage study with only 20 participants and no comparison group, so results may not apply to everyone. Surgery also carries standard risks like infection or poor healing.

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.

Participants

About 20 people

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

Started

Jan 2026

Expected to finish

Mar 2030

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.

Who is studied

Adult patients with major lower extremity amputations presenting to the tertiary Orthopedics and Traumatology clinic with complaints of chronic residual limb pain, phantom limb pain, and prosthesis intolerance, who are diagnosed with symptomatic neuroma and scheduled for surgical intervention.

Ages

18 to 70 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: * Age: Adults aged 18 to 70 years. * Amputation Status: Unilateral major lower extremity amputation (Transtibial, Transfemoral, or Knee Disarticulation). * Radiological Baseline: Absence of Heterotopic Ossification (HO) in the residual limb, confirmed by pre-operative X-rays (Walter Reed Classification Grade 0). * Diagnosis: Confirmed diagnosis of "Symptomatic Neuroma" validated by the Clinical Triad: 1. Neuropathic Pain: DN4 Questionnaire score ≥ 4. 2. Pain Intensity: Numeric Rating Scale (NRS) score ≥ 4. 3. Physical Exam: Positive Tinel's sign or palpation tenderness at a specific trigger point. 4. Radiology: Diagnostic Ultrasound visualization of the neuroma bulb. * Surgical Indication: Scheduled for RPNI surgery as part of the routine standard of care treatment protocol due to prosthesis intolerance or severe pain. * Consent: Willing and able to provide informed consent and attend follow-up visits. Exclusion Criteria: * CRPS: Diagnosis of Complex Regional Pain Syndrome (CRPS Type 1 or 2). * Concurrent Bone Surgery: Patients requiring simultaneous stump revision surgery (e.g., bone shortening, osteotomy, spur excision) or having existing HO (Walter Reed Grade \> 0). * Systemic Conditions: Uncontrolled diabetes mellitus (HbA1c \> 8.5%) or severe peripheral arterial disease compromising wound healing. * Cognitive Status: Cognitive impairment or psychiatric conditions preventing reliable completion of patient-reported outcome measures (PEQ, DN4). * History: Previous RPNI surgery at the same site (Recurrent RPNI cases).

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Conditions

The condition(s) this trial relates to.

neuralgia neuroma

As listed by the trial registrant

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

Lower extremity amputations Neuropathic pain Phantom limb pain after amputation Residual limb pain Symptomatic neuroma

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

  • University of Health Sciences, Gulhane Training and Research Hospital, Department of Orthopedics and Traumatology

    RECRUITING

    Ankara, Ankara, 06018, Turkey (Türkiye)

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