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A study to evaluate the use of colchicine to reduce inflammation in patients with deep vein thrombosis.

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Deep Vein Thrombosis, a condition where a blood clot forms in a deep vein, typically in the legs. A common long-term complication of this condition is Post-thrombotic syndrome, which is a set of symptoms like swelling, pain, and skin changes that can occur after the clot has been treated. The purpose of the study is to evaluate if taking a low dose of colchicine can help reduce the risk of developing this syndrome.

Participants in the study will be assigned to receive either a 0.5 mg tablet of colchicine once a day or a placebo once a day. The study will monitor participants over a period of time to observe the effects of the medication on their health and to check for any possible side effects. This process involves tracking various health outcomes to see how the treatment compares to the inactive pill.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Medication administration

    One of two types of tablets is taken once daily. the first type is colchicine, which is a 0.5 mg tablet used to reduce inflammation. the second type is a placebo, which is a tablet that does not contain an active medicine.

    The tablets are taken by mouth.

  2. Step 2

    Follow-up assessments

    At 6 months, assessments are performed to check for post-thrombotic syndrome (pts). pts is a condition that can occur after a deep vein thrombosis (dvt), which is a blood clot in a deep vein, usually in the leg. assessments include evaluating the severity of symptoms using the villalta score.

    At 12 months, further assessments are conducted to evaluate the safety and effectiveness of the medication. these evaluations include checking for post-thrombotic syndrome (pts), the occurrence of new blood clots (venous or arterial), bleeding events, and overall health. quality of life and functional status are also measured using specific questionnaires.

Who can join the trial?

5 criteria

  • You must be at least 18 years old.
  • You must have a first-time, acute (meaning it happened recently) case of deep vein thrombosis (a blood clot in a deep vein).
  • The blood clot must be symptomatic (causing noticeable symptoms like pain or swelling) and located in a proximal vein (a vein located closer to the center of your body, such as the popliteal vein behind the knee or higher up in the leg).
  • The blood clot must have been objectively confirmed (proven through medical tests like an ultrasound).
  • You must provide written informed consent (a signed document showing you understand the study and agree to participate).

Who cannot join the trial?

16 criteria

  • You have a known allergy or a severe sensitivity to colchicine (the study medicine) or any of the other ingredients used to make it.
  • You have any medical reason why you are not allowed to take colchicine based on official medical guidance.
  • You have active cancer, which is cancer that is currently present and growing in your body.
  • Your liver function tests are too high, specifically alanine or aspartate aminotransferase (enzymes that show if the liver is stressed) or total bilirubin (a substance produced by the liver) above certain levels.
  • Your kidney function is low, measured by creatinance clearance (a way to check how well your kidneys filter your blood) being less than 30 mL/min.
  • You have an HIV infection.
  • You have participated in another medical study involving a drug within the last 30 days or within a specific timeframe based on how long the previous drug stays in your system.
  • You are unwilling to provide consent, which means you do not agree to take part in the study.
  • You are pregnant, breastfeeding, or planning to become pregnant during the study.
  • You are a woman of childbearing age and are unwilling to use contraception (methods to prevent pregnancy) during the study.
  • You are taking medications that interact with colchicine, such as erythromycin or clarithromycin (types of antibiotics), which can change how the study medicine works in your body.
  • You need to take colchicine to treat a different medical condition.
  • You have active or chronic diarrhea (long-term loose or watery stools), inflammatory bowel disease (conditions like Crohn’s disease or ulcerative colitis that cause swelling in your digestive tract), colitis, irritable bowel syndrome, or blood dyscrasias (disorders where the blood does not function normally).
  • You have a recent or active infection, which is an illness caused by germs like bacteria or viruses.
  • You have a history of cirrhosis (scarring of the liver), chronic active hepatitis (long-term swelling of the liver), or severe liver disease.
  • You have recently used or are currently using immunosuppressive drugs (medicines that lower your body's ability to fight infections), such as steroids or other specific immune-system treatments.
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Investigated drugs

Colchicine is a medication used in this study to see if it can help reduce the risk of long-term complications, such as swelling and pain in the legs, following a blood clot in a deep vein.

What is already known about the treatment

Colchicine - This medication is taken as a tablet by mouth once a day. It is a well-established medicine used to treat various inflammatory conditions by interfering with how white blood cells move and react to triggers in the body. In this study, it is being investigated for its ability to reduce swelling and complications after a blood clot in the leg. This drug belongs to a group of medicines known as anti-inflammatory agents.

Investigated diseases

  • Deep vein thrombosis

    This condition occurs when a blood clot forms in one or more of the deep veins in the body, most commonly in the legs. The clot can obstruct the normal flow of blood through the vein. Over time, the presence of the clot may cause damage to the vein walls and the surrounding tissues. This damage can lead to long-term changes in how blood moves through the limb.

  • Post-thrombotic syndrome

    This is a chronic condition that can develop following a deep vein thrombosis. It is caused by damage to the vein valves or the vein walls, which impairs blood circulation. As the condition progresses, blood may pool in the lower limbs. This can lead to symptoms such as swelling, pain, and changes in skin color or texture.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521836-12-00Estimated enrolment122 patientsSponsorUniversita' Degli Studi G. D'Annunzio Di Chieti

sourced from the EU Clinical Trials Register and site verification

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