AuthorisedPhase II and Phase III (Integrated)Interventional

Evaluation of Botulinum TOXin type A in the treatment of Buerger’s disease

This research is investigating a treatment for Buerger’s disease using a special injection called Botulinum Toxin Type A. The main aim is to see how practical it is to give these injections to patients and if people can tolerate them well. Researchers will also be checking if the treatment helps improve blood flow to the affected areas, reduces pain, and helps ulcers heal. They will also look at how it affects Raynaud's syndrome, a common symptom of Buerger's disease, and overall quality of life. This study is an important step to understand if this treatment could benefit people living with Buerger's disease.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Centre Hospitalier Universitaire De Toulouse

Enrolment target

Start

22 Oct 2024

Buerger's disease

What is this study about?

This study is focused on Buerger’s disease, a condition that causes blood vessels to swell and get blocked, mainly in the hands and feet. This can lead to pain, sores, and sometimes serious issues like tissue damage. Researchers are exploring if a medicine called Botulinum Toxin Type A, which is often used in smaller amounts for muscle spasms, could help.

The main goal of this study is to see if it's practical and safe to give these injections to people with Buerger's disease. They want to check if patients can receive the injections as planned and if there are any side effects. Researchers will also be looking closely at several important things to see if the treatment is working. This includes measuring blood flow to the fingers and toes, checking how much pain people are feeling, and seeing if any ulcers (sores) are healing.

Beyond just healing and pain, the study also aims to understand how the treatment affects other symptoms, like Raynaud's syndrome, where fingers or toes become cold and numb. They'll also be asking about people's overall quality of life. By understanding all these aspects, the study hopes to find out if this injection could be a helpful new treatment option for Buerger's disease.

Key takeaways

The study explores a new injection for Buerger's disease.
It aims to check if the injection is safe and practical to use.
Researchers will monitor blood flow, pain, and ulcer healing.
Both men and women aged 18 and over can potentially join.
Participation involves clinic visits and health assessments over about six months.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women are welcome.

It's important to remember that this is a research study, and there will be other specific medical criteria that your doctor will need to check to make sure the study is right and safe for you. These might include details about your Buerger's disease, your overall health, and any other medications you are taking.

If you are interested, your doctor will discuss all the requirements with you to see if you would be a good fit for this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I 18 years old or older?
Have I been diagnosed with Buerger's disease?
Am I willing to attend regular clinic appointments?
Am I comfortable with receiving injections?
Are there any other medical conditions I have that might affect my participation (e.g. other serious illnesses or medications)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive injections of Botulinum Toxin Type A. The study will involve several visits to the clinic over a period of about six months. During these visits, the research team will carefully check your health and how you are responding to the treatment.

They will perform various assessments, including checks of your blood circulation using special tools like a laser Doppler (which measures blood flow) and thermal cameras (which show skin temperature). Your pain levels will be regularly assessed, and any sores or ulcers will be carefully measured and monitored for healing. You will also be asked to complete questionnaires about your quality of life. You may also need to track symptoms like Raynaud's attacks at home. The total duration of the injection plan and follow-up will be carefully explained to you.

Potential risks and benefits

Participating in this study might offer potential benefits, such as improved blood flow, reduced pain, and better healing of ulcers related to Buerger's disease. However, as with any medical treatment, there are potential risks, including possible side effects from the injection, which your doctor will explain in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is Buerger's disease?

Buerger's disease is a rare condition that causes swelling and blockage in the small and medium-sized blood vessels, usually in the hands and feet. This can lead to pain, sores, and in severe cases, tissue damage.

What is Botulinum Toxin Type A?

Botulinum Toxin Type A is a medicine, sometimes known by brand names, that is used in very small, controlled amounts. In this study, it's being explored for its potential to help with blood flow in Buerger's disease.

Will I know if I'm getting the real medicine or a dummy treatment?

The study details provided don't specify if there's a dummy treatment (placebo). Your doctor can confirm if this study involves a placebo and how it's designed.

How long will I be in the study?

The study involves injections and follow-up appointments over a period of about six months. Your doctor can give you a precise timeline for your participation.

Will this injection cure my Buerger's disease?

This is a research study to see if the injection can help manage symptoms and improve your condition. It is not designed to cure Buerger's disease, but to explore if it can be a helpful treatment.