Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain

PHASE1RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

March 13, 2025

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2025

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.

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Institutes of Health Clinical Center (CC)

NIH

NCT05695339 - Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain | Biotech Hunter | Biotech Hunter