Background
Peripheral artery disease
Peripheral artery disease is a condition in which the blood vessels in the legs become narrowed or blocked, usually due to a build-up of fatty deposits in the arteries.
A common symptom of PAD is claudication, which means pain or cramping in the legs during walking. This happens because the leg muscles do not get enough blood and oxygen when they are active.
Over time, PAD can make walking more difficult and reduce quality of life. In more severe cases, poor blood flow can lead to slow-healing wounds and increase the risk of serious complications such as heart attack, stroke, or amputation.
Colchicine
Colchicine is a medicinal plant that has been used for over 2,000 years, originally derived from the autumn crocus (Colchicum autumnale). It is primarily used to treat attacks of gout and other inflammatory diseases. Colchicine works by reducing inflammation in the body.
International Study
Random assignment
Placebo
(pill without active medication)
Blinded study
Frequently Asked Questions
What is the purpose of the research?
The aim is to investigate whether the medicine colchicine can reduce the risk of cardiovascular problems in people with blood vessel conditions in the legs.
Why this study?
Recent studies have shown that a low dose of colchicine can reduce the risk of cardiovascular problems, such as a heart attack or stroke, in people with heart disease. Therefore, we are now investigating whether a low dose of colchicine can also offer benefits for people with blood vessel problems in the legs.
How are we going to investigate this?
We are investigating the effectiveness of colchicine by comparing it to a placebo (a drug without an active ingredient) for at least 12 months. Standard care will not change; this study complements the standard treatment that every patient receives for peripheral arterial disease.
How long does the research take?
The study will take place in several Dutch hospitals and will last an average of approximately three years. Participants will remain involved for a minimum of one year and a maximum of five years.
Are you suitable to participate?
To participate, you must meet the following conditions:
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Be over 18 years of age.
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And:
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Have a history of peripheral arterial disease and one of the following conditions: diabetes, heart failure, impaired renal function, a history of myocardial infarction, stroke, or coronary artery stenosis; or
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Rest pain or sores on the legs/feet; or
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A history of leg artery surgery or amputation.
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You cannot participate in the study if you:
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Have an allergy or hypersensitivity to colchicine.
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Currently already using colchicine for another indication.
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Currently having diarrhea complaints.
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Has severe renal failure (eGFR < 15 mL/min/1.73 m2)
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Have cirrhosis of the liver or chronic liver disease.
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Are pregnant, breastfeeding or planning to become pregnant in the near future.
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Are you currently or soon planning to take any of the following medications: cyclosporine, verapamil, HIV protease inhibitors, antifungal triazoles, or macrolide antibiotics (except azithromycin).
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Unable to attend check-up appointments.
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Has a life expectancy of less than 1 year.
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Has diseases of blood cells (blood dyscrasias).
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Has severe heart failure (NYHA class IV).
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Have serious stomach or intestinal problems.
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Are participating or have recently participated in a clinical trial with an experimental drug (within 30 days of screening or while the drug is still in the body).
We recommend that you do not eat grapefruit (juice) during the examination.
What is the treatment?
During the study, participants will receive study medication. First, there will be a two-week trial period with colchicine to rule out side effects. This is followed by the remainder of the study: participants will be randomly assigned to receive either colchicine or a placebo daily. The participant, their doctor, and the research team will not know which medication they are receiving (double-blind). However, this information can be obtained in case of emergency.
When do research and measurements take place?
The study participant will have a hospital appointment at the start of the study and every six months. After three and nine months, the participant will be called to check on their progress and whether they are tolerating the medication. These additional visits are separate from regular care but will be combined with regular checkups as much as possible.
When should the research participant contact the researcher during the study?
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If the research participant is admitted or treated in a hospital.
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If the research participant suddenly develops health problems.
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If the study participant or the treating physician wishes to start the following medications: cyclosporine, verapamil, HIV protease inhibitors, antifungal triazoles, or macrolide antibiotics (with the exception of azithromycin).
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If the research participant no longer wants to participate in the research.
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If the contact details of the research participant change.
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If the research participant wishes to take part in another scientific study.
What side effects may occur?
Colchicine is generally well tolerated and has been used for years for gout. In previous studies with heart patients, the risk of serious side effects was very low (<0.1%). Possible mild side effects include abdominal pain, diarrhea, or nausea (in 10–15%). Rare side effects (<1%) include rash, blood abnormalities, or muscle pain.
If you have any complaints, please contact us. We will discuss any side effects with you at each appointment. Symptoms often disappear after reducing the dose or temporarily stopping. Serious side effects are rare; if in doubt, go to the emergency room.
How is the safety of participants guaranteed?
The safety and well-being of participants are always paramount in any research study. Research teams operate according to strict scientific and ethical regulations, which have been approved by the relevant authorities and an independent medical ethics committee. Remember that participation in research is always voluntary.
Privacy
If you participate in the study, you will be asked for your consent to collect, use, and store certain data. Below is an overview of this data.
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What data do we store?
- your name
- your gender
- your address
- your date of birth
- information about your health
- (medical) data that we collect during the research
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How do we protect your privacy?
Your data is encrypted without your name. Only the local hospital has the key to identify it.
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Why do we collect, use and store your data?
Your data is needed to properly conduct the research and to publish the results.
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Can we use your information for other research?
After this study, your data may also be used for other research. You decide this on the consent form.
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How long do we retain your data?
Your data must be kept for 25 years.
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Who can see your data?
Some researchers may view your data (including unencrypted data) on-site to monitor the research. They will keep this data confidential. We request your permission for access. The Health and Youth Care Inspectorate may access your data at any time without permission.
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Can you withdraw your consent for the use of your data?
You can withdraw your consent at any time. Data collected up to that point may still be used.
For information about your privacy rights, please visit the website of the Dutch Data Protection Authority.
If you have any questions or complaints, please contact the research location.