Injections of incobotulinumtoxin-A for diabetic nerve pain in the legs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and effectiveness of perineural injections of incobotulinumtoxin-A in patients suffering from diabetic neuropathic pain in the lower extremities. Participants will receive either the treatment or a placebo every 12 weeks for a total of 24 weeks, with assessments on pain relief, quality of life, and physical activity. The injections are guided by ultrasound to ensure accurate placement around the sciatic nerves. The study aims to determine the impact of this treatment on various health-related outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Are 18 years or older
* Are diagnosed with diabetes type I or II
* Score 3 or above on the Doleur Neuropathique 4 interview section
* Suffer from 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)
  * is present in both feet, roughly symmetrically.
  * has been present for at least 6 months
* Show sensory deficits and/or allodynia or hyperalgesia in the painful area, consistent with the IASP definition of probable chronic neuropathic pain40.
* 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

Where it's running

• Rigshospitalet Glostrup
  Glostrup Municipality, Denmark Recruiting

Study contacts

• Study coordinator: Marc Klee Olsen, MD
• Email: marc.klee.olsen@regionh.dk
• Phone: +4538633030

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.