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Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities
Sponsor: Rigshospitalet, Denmark
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
Conditions
Interventions
Incobotulinumtoxin-A 100 UNIT Injection
Perineural injection
Saline
Placebo containing trace amounts of human albumin and sucrose, diluted with 5ml of sterile saline.
Locations (1)
Rigshospitalet Glostrup
Glostrup Municipality, Denmark