Recruiting
Phase 2
Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities
Condition(s) studied
Diabetic Neuropathy, Painful
Investigational drug(s) / intervention(s)
Incobotulinumtoxin-A 100 UNIT InjectionSaline
Incobotulinumtoxin-A 100 UNIT Injection: Perineural injection
Saline: Placebo containing trace amounts of human albumin and sucrose, diluted with 5ml of sterile saline.
Study 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.
Eligibility
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
Primary outcome measure(s)
- Changes in daily neuropathic pain scores — Recorded once daily for 1 week prior to first injection and daily for the duration of the study. Outcome is defined as differences in change from baseline of average daily and weekly pain scores between groups.
Differences in pain scores, as measured by the Numeric Rating Scale (0-11), between groups.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Rigshospitalet Glostrup |
Glostrup Municipality |
Denmark |
Recruiting |
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