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RECRUITING
NCT05623111
PHASE2

Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test perineural injections (injections around a nerve) of incobotulinumtoxin-A in participants with diabetic nerve pain of the feet and lower legs. The main questions it aims to answer are: * Is the treatment safe and effective? * Does the treatment affect participants quality of life, depression, physical activity, daily life, and sensation? Participants will be treated every 12 weeks, for a total of 24 weeks, with either incobotulinumtoxin-A or a placebo.

Official title: Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities: A Double-blind, Randomized, Placebo-controlled Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2023-08-01

Completion Date

2027-12-01

Last Updated

2025-12-10

Healthy Volunteers

No

Interventions

DRUG

Incobotulinumtoxin-A 100 UNIT Injection

Perineural injection

DRUG

Saline

Placebo containing trace amounts of human albumin and sucrose, diluted with 5ml of sterile saline.

Locations (1)

Rigshospitalet Glostrup

Glostrup Municipality, Denmark