NCT05623111

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a randomized, double-blind, placebo-controlled trial, investigating the safety, efficacy, use of rescue medication, and impact on NPSI scores, health-related QoL, activities of daily living (ADLs) and levels of physical activity of perineural incobotulinumtoxin-A (iBonT-A) or placebo injections, in persons with DNP of the lower extremities. Participants will be randomly assigned via simple block randomization to receive either 100 units of iBonT-A in each leg (total of 200 units), or a placebo in each leg, injected perineurally around both distal sciatic nerves once every 12 weeks, for a total of 24 weeks. Injections are performed with sonographic guidance by an experienced operator. Contents of the blinded vials, containing either 100 U of iBonT-A or a placebo consisting of small amounts of sucrose and albumin are diluted in 5 ml of sterile saline. The injection point is just distal to the sciatic nerve bifurcation. The skin is penetrated from the lateral side using a non-cutting needle (Pajunk, SonoBlock, 22G x 80 mm, Facet S Tip). With the needle in plane in relation to the ultrasound probe, the nerves are visualized in short axis. The needle tip is placed inside the common sheath surrounding the tibial and peroneus communis nerves. The location of the needle tip is verified with small boli of sterile saline solution in combination with ultrasound. Correct distribution of the injectant is confirmed with dynamic scanning. Fluid distention must be seen around both components. When confirmation of optimal needle placement the 100 units iBonT-A or placebo is injected. The procedure is repeated for both legs. Participants will be asked to rate their neuropathic pain once a day, as well as register their daily use of rescue medication. Secondary outcome measures will be rated at baseline and at 4, 12, 16 and 24 weeks. Safety information consists of adverse events recording, as well as motorfunction and sensory changes over time.

Conditions

• Diabetic Neuropathy, Painful

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2027-05-01
• Completion: 2027-12-01
• First posted: 2022-11-21
• Last updated: 2025-12-10

Locations

1 site across 1 country: Denmark