Gornoslaskie Centrum Mwdyczne
Katowice, Poland
Recruiting
Study on Colchicine for Preventing Artery Narrowing in Patients with Lower Extremity Artery Disease
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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 a condition known as Lower Extremity Artery Disease (LEAD), which affects the blood vessels in the legs. The study is investigating the use of a medication called colchicine, which is taken orally in the form of a film-coated tablet. The main goal of the study is to see if colchicine can help prevent a problem called restenosis, where the artery becomes narrow again after treatment, in the superficial femoral artery. This artery is located in the thigh and is important for blood flow to the lower leg.
Participants in the study will receive either colchicine or another treatment involving a stent, which is a small tube placed in the artery to keep it open. Some stents release a medication called paclitaxel to help prevent restenosis. The study will compare the effectiveness and safety of colchicine with these stents over a period of time. The study will last for up to 24 months, during which the health of the artery will be monitored using various methods, including ultrasound examinations.
The study aims to understand how well colchicine works in preventing the artery from narrowing again and to assess its safety for patients with LEAD. Participants will be monitored for any side effects and changes in their condition, such as improvements in blood flow and quality of life. The results will help determine if colchicine is a beneficial treatment option for people with this condition.
The research process
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
10 criteria
- Must be older than 30 years.
- Must agree to give a blood sample for genetic testing.
- Must have a condition called **chronic lower limb ischemia**, which means reduced blood flow to the legs, classified as grade 3 to 5 according to the **Rutherford classification**.
- Must have a blockage or narrowing in the **superficial femoral artery**, which is a blood vessel in the leg, diagnosed through a test called **arteriography**. The blockage should be 50% or more, and the **ankle-brachial index (ABI)**, a test comparing blood pressure in the ankle and arm, should be less than 0.90.
- The affected area should be at least 1 cm away from the start of the **deep femoral artery** and the top of the **popliteal artery**, and not more than 3 cm above the knee cap.
- The diameter of the affected blood vessel should be between 4.0 mm and 7.0 mm, as judged by sight.
- The **popliteal artery** and at least one artery in the calf must be open and not blocked.
- Women must be postmenopausal or have had surgery to prevent pregnancy, and must agree in writing to avoid heterosexual intercourse or use two forms of birth control.
- Men must agree in writing to avoid heterosexual intercourse or use a condom.
- Must agree in writing to participate in the clinical trial.
Who cannot join the trial?
10 criteria
- Patients who are pregnant or breastfeeding cannot participate.
- Individuals with severe liver or kidney problems are excluded.
- Patients with a history of allergic reactions to colchicine or similar medications cannot join.
- People who have had a heart attack or stroke in the last 6 months are not eligible.
- Individuals with uncontrolled high blood pressure are excluded.
- Patients currently taking certain medications that interact with colchicine cannot participate.
- People with active infections or serious illnesses are not eligible.
- Individuals with a history of alcohol or drug abuse are excluded.
- Patients who have participated in another clinical trial within the last 30 days cannot join.
- Individuals with mental health conditions that affect their ability to follow study instructions are not eligible.
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Verified sites
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Verified Verified Małopolskie Centrum Sercowo-Naczyniowe AhoP
Chrzanow, PolandVerified Szpital Bielanski Im.Ks.Jerzego Popieluszki samodzielny publiczny zakład opieki zdrowotnej
Warsaw, Poland
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Investigated drugs
Colchicine
is an oral medication being studied for its ability to prevent the narrowing of the superficial femoral artery in patients with lower extremity artery disease. This study aims to see if colchicine can help keep the artery open after it has been treated with a stent that does not have any medication coating.
Paclitaxel
is a medication that is released locally from drug-eluting stents. In this study, it is used as a comparison to see how well colchicine works in preventing the artery from narrowing again. Paclitaxel is known for its ability to prevent cells from growing and is used to keep the artery open by stopping the growth of cells that could cause narrowing.
What is already known about the treatment
Colchicine
Colchicine is administered orally and is currently being studied for its effectiveness in preventing restenosis in the superficial femoral artery in patients with lower extremity artery disease. It is well-documented in medical literature for its use in treating gout and familial Mediterranean fever, but its role in vascular conditions is still under investigation. The main therapeutic indication in this trial is to prevent the narrowing of arteries after stent placement. At the molecular level, colchicine works by disrupting microtubule formation, which affects cell division and reduces inflammation. It is classified as an anti-inflammatory medication.
Paclitaxel
Paclitaxel is used in drug-eluting stents to locally release medication and prevent restenosis in arteries. It is widely recognized in medical literature for its use in cancer treatment and in preventing artery narrowing after stent placement. The main therapeutic indication in this context is to prevent restenosis in patients with lower extremity artery disease. Paclitaxel works by stabilizing microtubules, which inhibits cell division and reduces the proliferation of cells that can lead to artery narrowing. It is classified as an antineoplastic agent.
Investigated diseases
Lower Extremity Artery Disease – This condition involves the narrowing or blockage of the arteries in the legs, which can lead to reduced blood flow. It often results from atherosclerosis, where fatty deposits build up on the artery walls. As the disease progresses, individuals may experience pain or cramping in the legs, especially during physical activities like walking. Over time, the symptoms can worsen, leading to pain even at rest and potential complications such as sores or wounds on the feet that do not heal. In severe cases, the lack of blood flow can cause tissue damage and increase the risk of infections. The progression of the disease can significantly impact mobility and quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508935-30-00Protocol codeCOLSTENT_2023Estimated enrolment284 patientsSponsorUniwersytecki Szpital Kliniczny W Opolu
sourced from the EU Clinical Trials Register and site verification
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