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

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.

Timeline

Start

2023-08-01

Primary completion

2027-05-01

Completion

2027-12-01

Publications

• Klee M, Hormann Thomsen T, Enggaard TP, Bitsch MS, Simonsen L, Jensen RH, Biering-Sorensen B. Perineural injections of incobotulinumtoxin-A for diabetic neuropathic pain of the lower extremities: protocol for a phase II, single-centre, double-blind, randomised, placebo-controlled trial (the PINBOT study). BMJ Open. 2024 Jan 22;14(1):e074372. doi: 10.1136/bmjopen-2023-074372.

Drugs

Indications