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Could a common gout pill save legs and lives?

NCT ID NCT07536373

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study tests whether a low-dose anti-inflammatory drug called colchicine can help people with severe leg artery disease (chronic limb-threatening ischemia) avoid amputation or death. About 200 adults who recently had a procedure to restore leg blood flow will take either colchicine or a placebo daily for 12 months. The goal is to see if colchicine improves survival without major leg amputation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years. 2. Documented chronic limb-threatening ischemia, meeting the following: * Presence of ischemic symptoms compatible with CLTI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford classes 4-5 AND * Imaging evidence within the past 12 months showing atherosclerotic PAD, including CTA, MRA, angiography or duplex ultrasound AND * Ankle-Brachial Index (ABI) ≤0.80 or Toe-Brachial Index (TBI) ≤0.60 for patients without prior revascularization; ABI ≤0.85 or TBI ≤0.65 for those with prior revascularization OR * Ischemic rest pain alone (Rutherford class 4) defined as ankle systolic pressure \<50 mmHg, toe pressure of \<30 mmHg, transcutaneous PO2 of \<30 mmHg, or flat-line transtarsal pulse volume recording OR * Tissue loss with or without ischemic rest pain (Rutherford class 5) defined as ankle systolic pressure \<70 mmHg, toe pressure of \<50 mmHg, transcutaneous PO2 of \<30 mmHg, or flatline transtarsal pulse volume recording 3. Recent successful revascularization: * Underwent technically successful endovascular therapy (EVT) or surgical bypass within the last 7 days prior to randomization * For individuals requiring multiple revascularization attempts on the same index leg, the procedure considered for eligibility (in other words, the qualifying or index procedure) must be the final planned or anticipated revascularization attempt * There must be demonstrated graft or vascular patency after the qualifying revascularization procedure with one in-line blood flow to the foot, either by angiography, duplex ultrasound, CTA or MRA * There must be no immediate plan for reintervention 4. Informed Consent: * Demonstrated ability and willingness to adhere to the study protocol, attend scheduled follow-up visits, complete all required assessments, and provide written informed consent Exclusion Criteria: 1. Age \<18 years 2. Asymptomatic or mild disease: Patients who underwent revascularization for disease graded Rutherford classes 0-3 3. Patients with major tissue loss (Rutherford 6) in whom major amputation was planned at the time of screening 4. Failure to establish at least one tibial artery outflow after revascularization 5. Recent acute limb ischemia events within 2 weeks of screening 6. Clinical signs of active, uncontrolled, severe limb infection or septicemia, such as fever exceeding 38.5°C, a white blood cell count above 15,000 cells/µL, or hypotension, at the time of screening (this does not include osteomyelitis confined to the phalanges or metatarsal heads or foot cellulitis treatable with IV antibiotics at the time of revascularization) 7. Unstable hemodynamics after the index revascularization procedure 8. Unable to tolerate any antiplatelet agent or with severe bleeding diathesis 9. Acute coronary syndrome, acute stroke, or hospitalization for heart failure within 30 days of screening 10. Any contraindication or known intolerance to colchicine 11. Requirement for colchicine for another indication 12. Need for use of medications known to have drug-drug interactions with colchicine, particularly drugs known to inhibit CYP3A4 or P-glycoprotein 13. Active hepatitis or severe liver cirrhosis (Child Pugh C) 14. Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception 15. Previous (within 30 days) or concomitant participation in another clinical study with investigational medicinal product(s) 16. Life expectancy \<1 year

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Conditions

The condition(s) this trial relates to.

Chronic Limb-Threatening Ischemia limb ischemia peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chi Mei Medical Center

    NOT_YET_RECRUITING

    Tainan, 710, Taiwan

  • Linkou Chang Gung Memorial Hospital

    NOT_YET_RECRUITING

    Taoyuan, 333, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • Shin Kong Wu Ho-Su Memorial Hospital

    RECRUITING

    Taipei, Taipei, 111, Taiwan

  • Taipei Veterans General Hospital

    NOT_YET_RECRUITING

    Taipei, 112, Taiwan

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