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Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain

NCT05695339 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-04-13

No results posted yet for this study

Summary

Morton s neuroma is an irritation of the nerves that affect the feet. People with this condition may have burning or shooting pain in the balls of their feet. They may also have numbness in adjacent areas. These symptoms may become more frequent and severe over time. The pain may become permanent. Current treatments tend to be short-lived, and they do not work in all people. Better treatments are needed.

Objective:

To test a study drug, resiniferatoxin (RTX), in people with Morton s neuroma.

Eligibility:

Healthy people aged 18 and older who have Morton s neuroma and have tried other standard treatments that did not ease their pain.

Design:

Participants will be involved in the study up to 4 months.

They will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have X-rays of their affected feet. They will have tests to assess their pain and how their feet react to touch and changes in temperature. They will complete questionnaires about their pain.

RTX is injected into the foot at the site of the nerve pain. Participants will receive a shot to numb the area before the RTX is administered. They will be monitored in the clinic for 4 hours after they receive the RTX.

Participants will receive up to 5 follow-up phone calls per week. Each call will take 5 to 10 minutes. They will be asked about their foot pain and whether they have had any side effects from the RTX.

Participants will return to the clinic 4 weeks after the treatment. Previous tests will be repeated.

Conditions

  • Morton's Neuroma

Interventions

DRUG

Resiniferatoxin

An injection of 1-2 ml bupivacaine 0.5% will be placed around the affected branch of the neuroma (aiming at its proximal end) and dorsal adjacent tissue including the skin dorsally to the neuroma. This is to prevent pain caused by any microscopic spills of RTX during the. A second local anesthetic depot will be placed 1-2 cm proximally to the injection site around the affected branch of the plantar nerve to prevent pain caused by passive current transmission by axonal RTX excitation. Following the course of the affected nerve branch and ultra-sound visualization of the injection site, 0.5-2 ml bupivacaine 0.5% will be injected perineurally. Once the site has sufficient nerve block, the required RTX dose in a solution of 0.25 ml will be injected directly proximal to the Morton s neuroma under ultra-sound visualization.

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Andrew J Mannes, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-13
Primary Completion
2025-10-12
Completion
2025-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05695339 on ClinicalTrials.gov