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

Launched by RIGSHOSPITALET, DENMARK · Nov 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of perineural injections of a medication called incobotulinumtoxin-A to help relieve painful nerve problems in the feet and lower legs caused by diabetes. The main goals are to find out if this treatment is safe and effective, and how it may improve participants' quality of life, including their mood, physical activity, and daily activities. Eligible participants are adults aged 18 and older who have been diagnosed with diabetes and experience significant pain in both feet for at least six months.

During the study, participants will receive either the treatment or a placebo (a non-active substance) every 12 weeks for a total of 24 weeks. To participate, individuals must have a certain level of pain and specific sensory issues in their legs. They should also be stable on their current pain medications. Importantly, the study is currently recruiting participants, and those interested should also be able to speak, read, and understand Danish. This trial offers a chance to explore a new approach to managing diabetic nerve pain, which can greatly affect daily life.

Gender

ALL

Eligibility criteria

• 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