A Phase 3 interventional study of Colchicine 0.5 MG Oral Tablet Once Daily and Placebo in Chronic Limb-Threatening Ischemia, sponsored by Shin Kong Wu Ho-Su Memorial Hospital. Recruiting at 5 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Shin Kong Wu Ho-Su Memorial Hospital · Phase 3, Interventional, and Treatment
Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease, a condition in which narrowed or blocked arteries reduce blood flow to the legs. People with CLTI may have severe leg pain at rest, non-healing wounds, or gangrene, and face a high risk of leg amputation and death. Even after successful procedures to restore blood flow to the leg (called revascularization), many patients still experience serious complications. Inflammation in the blood vessels is believed to play an important role in these poor outcomes.
Colchicine is an anti-inflammatory medication that has been used safely for decades to treat gout and other inflammatory conditions. Recent large clinical trials have shown that a low dose of colchicine (0.5 mg per day) can reduce heart attacks and strokes in patients with coronary artery disease. However, it has not been studied in patients with CLTI.
The CIRCLE-Asia trial (Colchicine in Chronic Limb-Threatening Ischemia for Reduction of Complications and Limb Events in Asia) is a pilot study designed to evaluate whether colchicine can improve outcomes in patients with CLTI who have recently undergone a successful procedure to restore blood flow to their leg. Treatment begins within 7 days of the procedure.
This is a randomized, double-blind, placebo-controlled, multicenter trial conducted at five hospitals in Taiwan. A total of 200 adult patients with CLTI who have undergone successful revascularization will be randomly assigned in a 1:1 ratio to receive either colchicine 0.5 mg once daily or a matching placebo pill, in addition to their usual medications, for 12 months. Neither the patients nor the study doctors will know which treatment each patient receives.
The main outcome of interest is amputation-free survival, defined as the time until major amputation of the affected leg (above the ankle) or death from any cause, over 12 months of follow-up. The study will also assess other important outcomes including major limb complications, heart attacks, strokes, wound healing, changes in blood flow measurements, inflammatory blood markers, quality of life, and medication safety.
This pilot trial will provide the first randomized evidence on the potential benefits and safety of colchicine in CLTI patients and will help inform the design of a larger definitive trial.
356 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 71 are open to participants now.
This study's planned enrollment of 200 is above the median of 40 across 239 interventional studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →Shin Kong Wu Ho-Su Memorial Hospital is the lead sponsor of 65 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Documented chronic limb-threatening ischemia, meeting the following:
Recent successful revascularization:
:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Colchicine 0.5 mg per tab, taken 1 tab daily
Drug: Colchicine 0.5 MG Oral Tablet Once Daily
Placebo tablets matching in appearance with study drug, taken 1 tab per day
Drug: Placebo
Colchicine 0.5 mg oral tablet (Colchicine Tablets 0.5mg, Synmosa), taken once daily in addition to standard of care, for 12 months. Treatment is initiated within 7 days of successful lower-extremity revascularization. For patients experiencing intolerance such as diarrhea or gastrointestinal discomfort, the dose may be reduced to 0.25 mg daily (half tablet). If the medication is considered harmful, treatment is interrupted and resumed when safe.
Matching placebo tablet, identical in appearance to the colchicine 0.5 mg tablet (supplied by Synmosa Biopharma Corporation), taken orally once daily in addition to standard of care, for 12 months. Treatment is initiated within 7 days of successful lower-extremity revascularization. The same dose adjustment and discontinuation rules apply as for the active treatment arm.
Amputation-free survival
Defined as the time to major (above the ankle) amputation of the study limb or death from any cause
Time frame: 12 months
Number of Participants with Major (Above the Ankle) Non-Traumatic Amputation of the Study Limb
Number of participants who underwent major (above the ankle) non-traumatic amputation of the study limb during the 12-month follow-up period.
Time frame: 12 months
Major adverse limb event (MALE, including non-traumatic above-ankle amputation and major lower limb artery reintervention) and its components
Time frame: 12 months
Major adverse cardiovascular event (MACE, including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) and its components
Time frame: 12 months
Wound healing rates at 3, 6, 9 and 12 months for Rutherford 5 patients (or time to wound healing)
Time frame: 12 months
Number of Participants with Acute Limb Ischemia
Number of participants experiencing acute limb ischemia of the study limb during the 12-month follow-up period, adjudicated by a blinded clinical events committee.
Time frame: 12 months
Number of Deaths from Any Cause
Number of participants who died from any cause during the 12-month follow-up period.
Time frame: 12 months
Number of Deaths from Cardiovascular Causes
Number of participants who died from cardiovascular causes during the 12-month follow-up period, adjudicated by a blinded clinical events committee.
Time frame: 12 months
Number of Deaths from Limb-Related Causes
Number of participants who died from limb-related causes (e.g., fatal limb sepsis, complications of major amputation) during the 12-month follow-up period.
Time frame: 12 months
Number of Participants with Adverse Gastrointestinal Events
Number of participants experiencing adverse gastrointestinal events (including nausea, vomiting, abdominal pain, and diarrhea) during the 12-month treatment period.
Time frame: 12 months
Number of Participants with Adverse Hematologic Events
Number of participants experiencing adverse hematologic events (including leukopenia, thrombocytopenia, and anemia) during the 12-month treatment period.
Time frame: 12 months
Number of Participants with Serious Infections
Number of participants experiencing serious infections (defined as infections requiring hospitalization or intravenous antibiotics) during the 12-month follow-up period.
Time frame: 12 months
Number of Participants with Diarrhea
Number of participants experiencing diarrhea as an adverse event during the 12-month treatment period. Diarrhea is defined as the passage of three or more loose or watery stools within a 24-hour period, and severity is graded by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1 = increase of \<4 stools/day over baseline; Grade 2 = increase of 4-6 stools/day; Grade 3 = increase of ≥7 stools/day or hospitalization indicated; Grade 4 = life-threatening consequences; Grade 5 = death.
Time frame: 12 months
Number of Participants with Drug Discontinuation Due to Any Adverse Event
Number of participants who permanently discontinued the study drug due to any adverse event during the 12-month treatment period.
Time frame: 12 months
Change in Health-Related Quality of Life as Measured by the EQ-5D-5L Index Score
Change from baseline in EQ-5D-5L index score at 12 months. The EQ-5D-5L is a generic health status questionnaire. Index scores range from -0.6 to 1.0, where higher scores indicate better health-related quality of life.
Time frame: Baseline and 12 months
Change in Disease-Specific Quality of Life as Measured by the VASCUQOL-6 Score
Change from baseline in Vascular Quality of Life Questionnaire-6 (VASCUQOL-6) summary score at 12 months. VASCUQOL-6 scores range from 6 to 24, where higher scores indicate better vascular disease-specific quality of life.
Time frame: Baseline and 12 months
Change in Walking Ability as Measured by the Walking Impairment Questionnaire (WIQ) Score
Change from baseline in Walking Impairment Questionnaire (WIQ) composite score at 12 months. The WIQ assesses walking distance, walking speed, and stair climbing. Each domain is scored from 0 to 100, where higher scores indicate better walking ability.
Time frame: Baseline and 12 months
Change in Ankle-Brachial Index (ABI)
Change from baseline in ankle-brachial index (ABI) of the study limb at 12 months. ABI is calculated as the ratio of ankle systolic blood pressure to brachial systolic blood pressure (unitless ratio). Higher values indicate better lower-extremity arterial perfusion.
Time frame: Baseline and 12 months
Change in Toe-Brachial Index (TBI)
Change from baseline in toe-brachial index (TBI) of the study limb at 12 months. TBI is calculated as the ratio of toe systolic blood pressure to brachial systolic blood pressure (unitless ratio). Higher values indicate better distal perfusion.
Time frame: Baseline and 12 months
Change in Transcutaneous Oxygen Pressure (TcPO2)
Change from baseline in transcutaneous oxygen pressure (TcPO2) of the study limb at 12 months, measured in mmHg. Higher values indicate better tissue oxygenation.
Time frame: Baseline and 12 months
Changes in systemic inflammatory markers (e.g., C-reactive protein [CRP], interleukin-6 [IL-6]) from baseline
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Apr 2029, 34 months after the start.
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Studies of the drug tested here: Colchicine
Chronic Limb-Threatening Ischemia →
Shin Kong Wu Ho-Su Memorial Hospital