RecruitingPhase 2NCT05623111

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

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


Sponsor

Rigshospitalet, Denmark

Enrollment

80 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Incobotulinumtoxin-A 100 UNIT Injection and a drug called Saline for people with diabetic neuropathy, painful. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIncobotulinumtoxin-A 100 UNIT Injection

Perineural injection

DRUGSaline

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


Locations(1)

Rigshospitalet Glostrup

Glostrup Municipality, Denmark

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NCT05623111


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