Actively Recruiting
Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities
Led by Rigshospitalet, Denmark · Updated on 2025-12-10
80
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
M
Merz Pharmaceuticals GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Are 18 years or older
- Are diagnosed with diabetes type I or II
- Score 3 or above on the Doleur Neuropathique 4 interview section
- Have lower extremity pain that is their dominant overall pain
- Have pain rated at least 4 out of 10 on the NRS scale in both legs (average over past 7 days)
- Have pain present roughly symmetrically in both feet
- Have had this pain for at least 6 months
- Show sensory deficits and/or allodynia or hyperalgesia in the painful area consistent with probable chronic neuropathic pain
- Are on a stable analgesic treatment regimen for at least 1 month prior to inclusion and during the study
- Are using an approved, safe contraceptive if premenopausal
- Speak, read, and understand Danish
You will not qualify if you...
- Have a known allergy or hypersensitivity to Botulinum toxin A
- Have been treated with Botulinum toxin 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 injection area
- Expect to change pain medication during the study
- Have used topical agents like capsaicin or lidocaine in affected areas within 3 months prior to inclusion
- Are diagnosed with other causes of neuropathic pain or chronic lower extremity pain such as spinal stenosis, claudication, previous trauma or nerve injury, or cancer-related pain
- Have a psychiatric condition affecting study participation
- Are active abusers of alcohol or illegal substances
- Are using or receiving cannabis treatment
- Are pregnant or planning pregnancy during the study
- Score more than 12 on the Charlson Comorbidity Index
AI-Screening
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Trial Site Locations
Total: 1 location
1
Rigshospitalet Glostrup
Glostrup Municipality, Denmark, 2600
Actively Recruiting
Research Team
M
Marc Klee Olsen, MD
CONTACT
T
Trine Thomsen, MsC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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