Study on Botulinum Toxin Type A for Treating Buerger’s Disease in Patients Eligible for Injection Therapy

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Buerger’s disease, a rare condition that affects blood vessels in the arms and legs, leading to pain and tissue damage. The treatment being tested is called Botulinum Toxin Type A, which is a protein used in various medical treatments. In this study, it is administered as a powder that is mixed into a solution and injected into the body.

The purpose of the study is to evaluate how feasible it is to use this treatment for patients with Buerger’s disease. Participants in the study will receive planned injections of Botulinum Toxin Type A within specific timeframes. The study will monitor how well the treatment is tolerated by patients and will assess various health parameters, such as blood flow in the affected areas, pain levels, and the healing of any ulcers or sores. These assessments will take place at different intervals over the course of the study.

Throughout the study, the frequency and severity of symptoms associated with Buerger’s disease, such as Raynaud’s syndrome, will be recorded. This syndrome involves episodes of reduced blood flow to the fingers and toes, often triggered by cold temperatures. Participants will also complete quality of life questionnaires to help researchers understand the impact of the treatment on their daily lives. The study aims to gather comprehensive data to determine the potential benefits and safety of using Botulinum Toxin Type A for treating Buerger’s disease.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the trial will be confirmed based on specific criteria related to Buerger’s disease.

You will be asked to provide informed consent, confirming your understanding and willingness to participate in the study.

2 baseline assessments

Baseline assessments will be conducted to evaluate your current health status. These assessments include measuring tissue perfusion using a laser Doppler, toe or digital pressure, and a thermal camera.

Transcutaneous measurement of partial oxygen pressure (TCPO2) will also be performed. These assessments help establish a starting point for your treatment.

3 treatment administration

You will receive an injection of Botulinum Toxin Type A, which is a solution prepared from a powder form. This treatment is administered to help manage symptoms of Buerger’s disease.

The injection is given according to the study protocol, and the feasibility of this treatment is a primary focus of the trial.

4 follow-up visits

Follow-up visits are scheduled at one month (M1), three months (M3), and six months (M6) after the initial injection. During these visits, the same assessments conducted at baseline will be repeated to monitor changes.

Pain levels will be evaluated using a visual analog scale (VAS), and the healing of any ulcers will be assessed. The size and surface of ulcers, as well as the appearance of new ulcers, will be documented.

5 quality of life assessment

At the beginning (D0) and end (M6) of the study, you will complete quality of life questionnaires. These questionnaires are designed to assess the impact of the treatment on your daily life and overall well-being.

The questionnaires include EQ-5D-5L, Cochin, and Claus, which are standardized tools for evaluating health-related quality of life.

6 final evaluation

At the end of the study period, a final evaluation will be conducted. This includes a comprehensive review of all collected data to assess the effectiveness and safety of the treatment.

The study aims to determine the feasibility of the treatment and its impact on Buerger’s disease symptoms, including the need for any amputations and the frequency of Raynaud’s syndrome episodes.

Who Can Join the Study?

Age must be 18 years or older.
Must have Buerger’s disease as defined by the Olin criteria.
Must have digital ischemia (poor blood flow to fingers or toes) with severe symptoms in the upper or lower limbs, such as:
- Upper limb: Pain and/or skin issues for at least 15 days and digital pressure less than 50 mmHg, or TCPO2 (a measure of oxygen in tissues) less than 30 mmHg.
- Lower limb: Pain and/or skin issues for at least 15 days and ankle pressure less than 50 mmHg (or 70 mmHg if diabetic), or toe pressure less than 30 mmHg (or 50 mmHg if diabetic), or TCPO2 less than 30 mmHg.
Must be able to attend study visits.
Must be able to complete a daily study agenda.
Must be able to provide free and informed consent.
Must be a member of a Social Security scheme.

Who Cannot Join the Study?

Patients with Buerger’s disease cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.10.2024

Trial locations

Investigated drugs:

Botulinum Toxin Type A – Haemagglutinin Complex

Botulinum Toxin Type A is a medication used in this clinical trial to treat Buerger’s disease. It is a substance that can help relax muscles and reduce pain by blocking nerve signals. In this trial, it is being tested to see if it can help improve blood flow and reduce symptoms in patients with Buerger’s disease, which is a condition that affects blood vessels in the arms and legs. The goal is to see if the treatment is feasible and effective for patients who meet the trial’s criteria.

Investigated diseases:

Thromboangiitis obliterans

Buerger’s disease – Buerger’s disease, also known as thromboangiitis obliterans, is a rare condition that affects the blood vessels in the arms and legs. It is characterized by inflammation and clotting in small and medium-sized arteries and veins, leading to reduced blood flow. As the disease progresses, it can cause pain in the affected areas, especially during physical activity. Over time, the lack of blood flow can result in tissue damage, leading to ulcers and, in severe cases, gangrene. The disease is often associated with tobacco use, and symptoms may include coldness, numbness, and tingling in the limbs. Raynaud’s phenomenon, where fingers or toes turn white or blue in response to cold or stress, can also occur in individuals with Buerger’s disease.

Trial ID:

2024-517772-38-00

Protocol code:

RC31/20/0445

Trial Phase:

Therapeutic use (Phase IV)

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Study on Botulinum Toxin Type A for Treating Buerger’s Disease in Patients Eligible for Injection Therapy

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