Study for people with Peripheral Neuropathy

Recruiting Not a phased study

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Not a phased study
Sponsor Prometei Pain Rehabilitation Center
Registry number NCT05009394
Started 20 June 2023 Today 16 October 2026 Estimated completion 1 June 2026

Past estimated completion. The registry still lists this trial as open, and the date it gave for finishing has been and gone. Confirm with the official record before you act on it.

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Dandenong Hospital, Monash Health Melbourne Australia Not yet recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 110

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* The participant must have a major limb amputation.

* The participant is ≥ 18 years old at the time of consent.

* The participant must be in generally good health to undergo a surgical intervention, as per the clinical investigator's opinion.

* Time since the last amputation must be over a year at the time of consent.

* The participant must have an average residual limb pain score equal or greater than 4 on the Numerical Rating Scale (NRS, 0-10) after the baseline period.

* If the participant has been prescribed pharmacological treatments for pain, there must be no variations in dosage (steady consumption) for at least 1 month before the screening visit.

* If the participant has been prescribed non-pharmacological treatments for pain, such as spinal cord stimulation, transcutaneous electrical nerve stimulation, and mirror therapy, the treatment must have ended at least 1 month before the screening visit.

* The participant must have a stable prosthetic fitting for at least a month before the screening visit.

* The participant has a sufficient understanding of the language in which the assessments will be conducted, as per the clinical investigator's opinion.

Exclusion Criteria:

* Neurological or other conditions that affect nerve regeneration for the nerve to be treated.

* Active infection in the residual limb.

* Prior RPNI or TMR surgery of the nerve to be treated (with painful neuroma) to address postamputation pain.

* Mental disorders (e.g., schizophrenia, paranoia, psychosis, etc.), reluctance, or language difficulties that result in difficulty understanding the meaning of study participation.

* Ongoing participation in a clinical study that the clinical investigator deems detrimental to participation in this study.

Dates on the record

Started 20 June 2023
Estimated completion 1 June 2026
Registry last updated 9 January 2025
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 9 January 2025.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.