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New treatment option for Chronic Limb-Threatening Ischemia
Official title Colchicine in Chronic Limb-Threatening Ischemia
ClinicalTrials.gov ID: NCT07536373
What this study is testing
What is Colchicine 0.5 MG Oral Tablet Once Daily?
Colchicine 0.5 MG Oral Tablet Once Daily is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic limb-threatening ischemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years.
- 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...
- 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...
You likely can't join if
- Age \<18 years
- Asymptomatic or mild disease: Patients who underwent revascularization for disease graded Rutherford classes 0-3
- Patients with major tissue loss (Rutherford 6) in whom major amputation was planned at the time of screening
- Failure to establish at least one tibial artery outflow after revascularization
- Recent acute limb ischemia events within 2 weeks of screening
- 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...
See the full eligibility criteria
- Age ≥18 years.
- 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
- 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...
- 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
- 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
- Age \<18 years
- Asymptomatic or mild disease: Patients who underwent revascularization for disease graded Rutherford classes 0-3
- Patients with major tissue loss (Rutherford 6) in whom major amputation was planned at the time of screening
- Failure to establish at least one tibial artery outflow after revascularization
- Recent acute limb ischemia events within 2 weeks of screening
- 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...
- Unstable hemodynamics after the index revascularization procedure
- Unable to tolerate any antiplatelet agent or with severe bleeding diathesis
- Acute coronary syndrome, acute stroke, or hospitalization for heart failure within 30 days of screening
- Any contraindication or known intolerance to colchicine
- Requirement for colchicine for another indication
- Need for use of medications known to have drug-drug interactions with colchicine, particularly drugs known to inhibit CYP3A4 or P-glycoprotein
- Active hepatitis or severe liver cirrhosis (Child Pugh C)
- Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception
- Previous (within 30 days) or concomitant participation in another clinical study with investigational medicinal product(s)
- Life expectancy \<1 year
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taipei, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
- Taoyuan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taipei, Taiwan; Tainan, Taiwan; Taipei, Taiwan; Taoyuan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.