Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities (PINBOT)
Diabetic Neuropathy, Painful
About this trial
This is an interventional treatment trial for Diabetic Neuropathy, Painful
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
Sites / Locations
- Rigshospitalet GlostrupRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Incobotulinumtoxin-A
Placebo
100 units of incobotulinumtoxin-A in 5ml of sterile saline around both distal ischial nerves.
5ml sterile saline with small amounts of human albumin and sucrose (identical to binding agents in active vials)