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Could a common gout pill save legs and lives?
NCT ID NCT07536373
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Chi Mei Medical Center
NOT_YET_RECRUITINGTainan, 710, Taiwan
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Linkou Chang Gung Memorial Hospital
NOT_YET_RECRUITINGTaoyuan, 333, Taiwan
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National Taiwan University Hospital
RECRUITINGTaipei, 100, Taiwan
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Shin Kong Wu Ho-Su Memorial Hospital
RECRUITINGTaipei, Taipei, 111, Taiwan
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Taipei Veterans General Hospital
NOT_YET_RECRUITINGTaipei, 112, Taiwan
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Other studies related to the condition(s) this trial covers.
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