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Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities (PINBOT)
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.
Details
| Lead sponsor | Rigshospitalet, Denmark |
|---|---|
| Phase | PHASE2 |
| Status | RECRUITING |
| Enrolment | 80 |
| Start date | Tue Aug 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Dec 01 2027 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Diabetic Neuropathy, Painful
Interventions
- Incobotulinumtoxin-A 100 UNIT Injection
- Saline
Countries
Denmark