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

• Status: Not yet recruiting
• Trial end date: 2026-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: incobotulinumtoxinA

Criteria

Inclusion Criteria:

• Are diagnosed with diabetes type I or II

• Have a diagnosis of diabetic neuropathic pain of the lower extremities which

• is considered by the participant as their dominant overall dominant pain

• is rated at least 4 out of 10 of the NRS pain scale in both legs (on average over the past 7 days)

• fulfils the IASP criteria37 for Definite chronic neuropathic pain

• has been verified using nerve conduction studies

• is present in both legs, below the knee

• has been present for at least 6 months

• Are in a stable analgesic treatment regime for at least 1 month prior to inclusion and for the duration of the study

• Are using an approved, safe contraceptive (for premenopausal women)

• Speak, read, and understand Danish

Exclusion Criteria:

• • Have a known allergy or hypersensitivity to BonT-A

• Have been treated with BonT in the last 6 months.

• Are diagnosed with myasthenia, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

• Have a known malignant condition

• Have an ongoing infection in the area of injection

• Are expecting to change their pain medication during the study period

• Have been treated with topical agents such as capsaicin or lidocaine products in the affected areas for at least 3 months prior to inclusion

• Are diagnosed with a competing cause of central or peripheral neuropathic pain, or other painful chronic conditions of the lower extremities, such as:

• spinal stenosis

• claudication

• previous trauma or nerve injury

• cancer related pain

• Have a psychiatric condition that affects their completion of the study, as assessed by the investigator.

• Are active abusers of alcohol or illegal substances

• Are using or receiving treatment with cannabis products of any kind

• Are pregnant or planning pregnancy during the study period

• Score more than 12 on the Charlson Comorbidity Index