Injections of incobotulinumtoxin-A for diabetic nerve pain in the legs
Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities: A Double-blind, Randomized, Placebo-controlled Study
This study is testing if injections of a special medication can help people with diabetic nerve pain in their legs feel better and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Glostrup Municipality) |
| Trial ID | NCT05623111 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of diabetes and chronic pain in the lower extremities rated at least 4 out of 10 on a pain scale.
Not a fit: Patients with known allergies to incobotulinumtoxin-A or those who have received similar treatments in the past six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate diabetic neuropathic pain and improve the quality of life for affected patients.
How similar studies have performed: While the specific use of incobotulinumtoxin-A for this condition is novel, similar approaches using botulinum toxin for pain management have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Glostrup Municipality
- Rigshospitalet Glostrup — Glostrup Municipality, Denmark (Recruiting)
Study contacts
- Study coordinator: Marc Klee Olsen, MD
- Email: marc.klee.olsen@regionh.dk
- Phone: +4538633030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.