Study on Colchicine for Preventing Artery Narrowing in Patients with Lower Extremity Artery Disease

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What is this study about?

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.

1 joining the study

Upon joining the study, the patient will be required to sign an informed consent form. This includes agreeing to participate in the clinical trial and allowing blood samples to be taken for genetic testing.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying the presence of lower extremity artery disease and ensuring the patient meets specific criteria, such as age and medical history.

3 treatment with colchicine

The patient will begin treatment with colchicine, administered orally in the form of film-coated tablets. The dosage is 0.5 mg per tablet. The frequency and duration of administration will be determined by the study protocol.

4 stent implantation

A vascular stent will be implanted in the superficial femoral artery. This procedure aims to maintain blood flow and prevent restenosis, which is the re-narrowing of the artery.

5 follow-up assessments

Regular follow-up assessments will be conducted to monitor the patency of the artery and evaluate the effectiveness of the treatment. These assessments include Doppler ultrasound examinations and other relevant tests.

6 evaluation of outcomes

The primary outcome is the patency of the superficial femoral artery after 24 months. Secondary outcomes include the need for additional procedures, changes in the ankle-brachial index, and improvements in ischemic pain and quality of life.

7 completion of the study

The study is expected to conclude by December 31, 2027. Final evaluations will be conducted to assess the long-term effects of the treatment and any adverse events experienced during the trial.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Szpital Bielanski Im.Ks.Jerzego Popieluszki samodzielny publiczny zakład opieki zdrowotnej	Warsaw	Poland

Other Sites

Site Name	City	Country
Wojewodzki Szpital Zespolony W Kielcach SPZOZ	Kielce	Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Gornoslaskie Centrum Mwdyczne	Katowice	Poland
Uniwersytecki Szpital Kliniczny W Opolu	Opole	Poland
Mypxayupiws Cobzynq Sfnwnmoieccowglopq Afzi	Chrzanow	Poland
Ugybtqbneriid Szdhgzo Kuqshtqwy Nm 2 Pat W Sbmbkzckwj	Szczecin	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.08.2025

Trial locations

Investigated drugs:

Colchicine

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.

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 ID:

2023-508935-30-00

Protocol code:

COLSTENT_2023

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Colchicine for Preventing Artery Narrowing in Patients with Lower Extremity Artery Disease

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