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Study of Incobotulinumtoxin-A Injections for Diabetic Neuropathic Pain in the Lower Limbs

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying diabetic neuropathic pain, which is a type of pain that affects people with diabetes, particularly in the lower parts of their legs. The study will use a treatment called incobotulinumtoxin-A, also known as Xeomin, which is a form of botulinum toxin type A. This treatment is administered through injections around the nerves in the legs to see if it can help relieve pain.

The purpose of the study is to investigate how effective and safe these injections are for people experiencing this type of pain. Participants in the study will receive either the actual treatment or a placebo, which is a substance with no active medication, to compare the effects. The study will last for about 24 weeks, during which participants will have regular check-ups to monitor their pain levels and overall health.

Throughout the study, various aspects of the participants' health will be assessed, including their muscle strength, quality of life, and any changes in their pain symptoms. This will help researchers understand the potential benefits and any side effects of the treatment. The study aims to provide valuable information that could lead to better management of diabetic neuropathic pain in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as age, diabetes diagnosis, and the presence of diabetic neuropathic pain in both legs.
You will be asked to provide information about your current pain levels and any medications you are taking. This information will help establish a baseline for the study.
Step 2
Randomization
After the initial visit, you will be randomly assigned to one of two groups: the active treatment group or the placebo group. This process is called randomization and ensures that the study results are unbiased.
Step 3
Treatment administration
If you are in the active treatment group, you will receive perineural injections of incobotulinumtoxin-A around the distal ischial nerve. These injections are intended to help relieve pain.
If you are in the placebo group, you will receive injections that do not contain the active medication. This is to compare the effects of the active treatment against no active treatment.
Step 4
Follow-up visits
You will attend regular follow-up visits over a period of 24 weeks. During these visits, your pain levels and any changes in your condition will be assessed.
You may be asked to complete questionnaires about your pain, quality of life, and any side effects you experience. These assessments help determine the effectiveness and safety of the treatment.
Step 5
Final assessment
At the end of the 24-week period, you will have a final assessment. This will include a comprehensive evaluation of your pain levels and overall health.
The results from this assessment will be compared to your initial baseline measurements to determine the impact of the treatment.

Who can join the trial?

12 criteria

Must be 18 years of age or older.
Must have been diagnosed with diabetes mellitus, which can be either type I or type II diabetes.
Must have diabetic neuropathic pain that:
- Is considered by the participant as their main pain.
- Is rated at least 4 out of 10 on a pain scale in both legs on average over the past 7 days.
- Meets the criteria for definite chronic neuropathic pain as defined by the International Association for the Study of Pain (IASP).
- Has been confirmed through nerve conduction studies, which are tests that measure how well nerves can send electrical signals.
- Is present in both legs, below the knee.
- Has been present for at least 6 months.
- Must be on a stable pain treatment plan for at least 1 month before joining the study and continue this plan during the study.
- Must not have used topical agents like capsaicin or lidocaine products on the affected areas for at least 3 months before joining the study.
- If a premenopausal woman, must be using an approved, safe contraceptive.
- Must be able to speak, read, and understand Danish.

Who cannot join the trial?

3 criteria

Patients who do not have diabetic neuropathic pain in the lower extremities cannot participate. This means the study is only for those who have nerve pain in their legs or feet due to diabetes.
Patients who are not within the specified age range cannot participate. The study is for adults only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care are not included.

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Rigshospitalet
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Glostrup, Denmark

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Investigated drugs

Incobotulinumtoxin-A is a type of botulinum toxin used in this study to help manage pain caused by nerve damage in people with diabetes. It is injected near the nerves in the lower legs to see if it can reduce pain. The study aims to find out how well this treatment works and if it is safe for patients to use. The injections are given on both sides of the body to target the areas where patients experience pain.

Clostridium Botulinum Neurotoxin Type A (150Kd), Free Of Complexing Proteins

What is already known about the treatment

Incobotulinumtoxin-A – Incobotulinumtoxin-A is administered through injections near the nerves, specifically targeting areas affected by diabetic neuropathic pain in the lower extremities. Currently, it is being studied in clinical trials to assess its effectiveness and safety for this condition. The main therapeutic use being explored is the relief of pain associated with diabetic neuropathy. At the molecular level, it works by blocking the release of certain chemicals that transmit pain signals, thereby reducing pain sensation. It is classified pharmacologically as a neurotoxin, commonly known for its use in reducing muscle activity.

Investigated diseases

Diabetic Neuropathic Pain – Diabetic neuropathic pain is a type of nerve damage that occurs in individuals with diabetes. It primarily affects the nerves in the lower extremities, such as the legs and feet. This condition is characterized by sensations of burning, tingling, or sharp pain. Over time, the pain can become more intense and persistent. It may also lead to a loss of sensation in the affected areas. The progression of this condition is often linked to the duration and severity of diabetes.