Colchicine for people with severe limb-threatening leg artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial tests whether daily 0.5 mg colchicine reduces complications in adults with chronic limb-threatening ischemia (CLTI). Participants are randomly assigned to receive either colchicine or placebo for a defined period, in addition to standard care. The study focuses on inflammation as a potential contributor to poor outcomes after revascularization. Outcomes of interest include amputation-free survival, wound healing, and cardiovascular events. The trial is conducted across multiple Taiwan-based hospitals with lead sponsorship from Shin Kong Wu Ho-Su Memorial Hospital and collaboration from national centers.

Why it matters

Who can join: the full rules

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

Where it's running

• Shin Kong Wu Ho-Su Memorial Hospital
  Taipei, Taipei, Taiwan Recruiting
• National Taiwan University Hospital
  Taipei, Taiwan Recruiting
• Chi Mei Medical Center
  Tainan, Taiwan Not yet recruiting
• Taipei Veterans General Hospital
  Taipei, Taiwan Not yet recruiting
• Linkou Chang Gung Memorial Hospital
  Taoyuan, Taiwan Not yet recruiting

Study contacts

• Principal investigator: Donna SH Lin, MD — Shin Kong Wu Ho-Su Memorial Hospital
• Study coordinator: Donna SH Lin, MD
• Email: donna.lin24@gmail.com
• Phone: +886-2-2833-2211

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.