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Perineural injections of incobotulinumtoxin-A for diabetic neuropathic pain of the lower extremities: A double-blind, randomized, placebo-controlled study (PINBOT)
EU CTIS ID: 2022-500727-68-01
What this study is testing
This study will investigate the efficacy and safety of bilateral perineural incobotulinumtoxinA (iBonT-A) injections in persons with diabetic neuropathic pain of the lower extremities.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 years of age or older
- Diagnosed with diabetes mellitus, type I or II
- Diagnosed with diabetic neuropathic pain that is a) by the participant as their dominant overall dominant pain b) rated at least 4 out of 10 of the NRS pain scale in both legs on average over the past 7 days c) fulfils the IASP criteria for Definite chronic neuropathic pain d) has been verified using nerveconduction studies e) present in both legs, below the knee f) has been present for at least 6 months
- In a stable analgesic treatment regime for at least 1 month prior to inclusion and for the duration of the study
- Not been treated with topical agents such as capsaicin or lidocaine products in the affected areas for at least 3 months prior to inclusion
- Using an approved, safe contraceptive (for premenopausal women)
You likely can't join if
- A known allergy or hypersensitivity to botulinumtoxin
- Using or receiving treatment with cannabis products of any kind
- Pregnant or planning pregnancy during the study period
- A score of more than 25 on the Charlson Comorbidity Index
- Treated with botulinumtoxin in the last 6 months
- Diagnosed with myasthenia, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
See the full eligibility criteria
- 18 years of age or older
- Diagnosed with diabetes mellitus, type I or II
- Diagnosed with diabetic neuropathic pain that is a) by the participant as their dominant overall dominant pain b) rated at least 4 out of 10 of the NRS pain scale in both legs on average over the past 7 days c) fulfils the IASP criteria for Definite chronic neuropathic pain d) has been verified using nerveconduction studies e) present in both legs, below the knee f) has been present for at least 6 months
- In a stable analgesic treatment regime for at least 1 month prior to inclusion and for the duration of the study
- Not been treated with topical agents such as capsaicin or lidocaine products in the affected areas for at least 3 months prior to inclusion
- Using an approved, safe contraceptive (for premenopausal women)
- Speak, read, and understand Danish
- A known allergy or hypersensitivity to botulinumtoxin
- Using or receiving treatment with cannabis products of any kind
- Pregnant or planning pregnancy during the study period
- A score of more than 25 on the Charlson Comorbidity Index
- Treated with botulinumtoxin in the last 6 months
- Diagnosed with myasthenia, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- A known malignant condition
- An ongoing infection in the area of injection (right above the knee joint)
- Expect to change their pain medication during the study period
- Diagnosed with a competing cause of central or peripheral neuropathic pain, or other painful chronic conditions of the lower extremities, such as spinal stenosis, claudicatio, previous traume or nerve injury or cancer related pain.
- A psychiatric condition that affects their completion of the study, as assessed by the investigator.
- Active abusers of alcohol or illegal substances
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.