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

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.

Inclusion Criteria:Are diagnosed with diabetes type I or IIHave a diagnosis of diabetic neuropathic pain of the lower extremities whichis considered by the participant as their dominant overall dominant painis 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 painhas been verified using nerve conduction studiesis present in both legs, below the kneehas been present for at least 6 monthsAre in a stable analgesic treatment regime for at least 1 month prior to inclusion and for the duration of the studyAre using an approved, safe contraceptive (for premenopausal women)Speak, read, and understand DanishExclusion Criteria:• Have a known allergy or hypersensitivity to BonT-AHave been treated with BonT in the last 6 months.Are diagnosed with myasthenia, Eaton-Lambert syndrome, or amyotrophic lateral sclerosisHave a known malignant conditionHave an ongoing infection in the area of injectionAre expecting to change their pain medication during the study periodHave been treated with topical agents such as capsaicin or lidocaine products in the affected areas for at least 3 months prior to inclusionAre diagnosed with a competing cause of central or peripheral neuropathic pain, or other painful chronic conditions of the lower extremities, such as:spinal stenosisclaudicationprevious trauma or nerve injurycancer related painHave a psychiatric condition that affects their completion of the study, as assessed by the investigator.Are active abusers of alcohol or illegal substancesAre using or receiving treatment with cannabis products of any kindAre pregnant or planning pregnancy during the study periodScore more than 12 on the Charlson Comorbidity Index