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Taking people in United StatesPhase 3

Testing Low-Dose Colchicine for People With Peripheral Artery Disease

Tests a low dose of colchicine, an anti-inflammatory pill, in adults with narrowed leg arteries.

Key facts

Who runs it
Population Health Research Institute
Where
Ann Arbor, Boston, Chapel Hill, Chicago, Columbus, Dallas, Detroit, Durham, El Paso, Gainesville, Greensboro, McKinney, Milwaukee, Nashville, New Haven, New York, Newark, Norfolk, Raleigh, Rochester, Seattle, and Tampa, United StatesSee the 24 sitesAlso in 10 other countries, 74 sites
Registry title
Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
Status
Recruiting
Phase
Phase 3
People taking part
6,150 people, planned
Started
6 May 2021
Expected to end
Dec 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Colchicine 0.5 MG Oral Tablet
  • Colchicine-Placebo
Record updated
5 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with peripheral artery disease in the legs who have symptoms. It tests whether low-dose colchicine, an anti-inflammatory drug, reduces vascular events.

Age
Older than 18 years
Sex
All sexes can join
Disease stage
Symptomatic atherosclerotic peripheral artery disease of the legs. This means leg pain when walking (with an ankle/arm blood pressure ratio of 0.90 or lower, or an artery narrowing of 50% or more, plus another condition such as diabetes, heart failure, chronic kidney disease or atherosclerosis in more than one vascular bed), or rest pain, tissue death or gangrene of the limb, or past leg bypass or artery-opening procedure, or past leg or foot amputation because of artery disease.
Earlier treatment
People who need colchicine long term for another reason cannot join. People who take or plan to take cyclosporine, verapamil, HIV protease inhibitors, azole antifungals or macrolide antibiotics (except azithromycin) long term cannot join.
Biomarker or test result
Ankle/arm blood pressure ratio of 0.90 or lower, or artery stenosis of 50% or more. If ankle arteries cannot be compressed, toe pressure of 60 mm Hg or lower, or toe-brachial index of 0.70 or lower.

Main reasons for not taking part

  • Cannot take colchicine
  • Active diarrhoea
  • eGFR below 30 mL/min/1.73 m2
  • Cirrhosis or severe chronic liver disease
  • Pregnant or breast-feeding, or able to have children without reliable contraception

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Age > 18 years
  • Symptomatic atherosclerotic LE PAD fulfilling at least one of the following:; Intermittent claudication with ankle/arm blood pressure ratio* (ABI ≤ 0.90) or artery stenosis ≥ 50% plus one of i. >1 vascular bed affected by atherosclerosis ii. Diabetes iii. Heart failure iv. Chronic kidney disease (eGFR < 60 mL/min/1.73 m2); Rest pain (mostly in foot) OR necrosis of limb OR gangrene of limb (corresponding to either Fontaine stages 3 or 4 OR Rutherford Classification categories 4 to 6). All must have an ankle/arm blood pressure ratio* (ABI ≤ 0.90) OR artery stenosis ≥ 50%; In cases of incompressible ankle arteries, the presence of toe pressure ≤ 60 mm Hg or toe-brachial index ≤ 0.70 is acceptable; Revascularization defined as limb bypass surgery or endovascular revascularization procedures (irrespective of the specific device used), including percutaneous transluminal angioplasty/stent of iliac or infra-inguinal arteries or extra-anatomical bypass surgery; Leg or foot amputation for arterial vascular indications
  • Written or verbal informed consent from the patient

Who cannot take part

  • Cirrhosis or severe chronic liver disease
  • Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (with the exception of azithromycin)
  • eGFR < 30 mL/min/1.73 m2
  • Contraindication to colchicine
  • Long term requirement for colchicine for another clinical indication
  • Active diarrhoea
  • Woman who is pregnant, or breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study
  • Patients who are deemed unlikely to return for follow-up
  • Patients with life expectancy < 1 year

Where in United States

Also in 10 other countries, 74 sites

  • University of Michigan HealthAnn Arbor, United StatesContact: Peter Henke, MDTaking people
  • Boston Medical CenterBoston, United StatesContact: Jeffrey Siracuse, MDTaking people
  • University of North Carolina at Chapel HillChapel Hill, United StatesContact: Katharine McGinigleTaking people
  • University of Chicago Medical CenterChicago, United StatesContact: Trissa BabrowskiTaking people
  • Ohio State University Wexner Medical CenterColumbus, United StatesContact: Jake HemingwayTaking people
  • Southwest Family MedicineDallas, United StatesContact: Chrisette DharmaTaking people
  • University of Texas Southwestern Medical CenterDallas, United StatesContact: Josh BeckmanTaking people
  • Henry Ford Health SystemDetroit, United StatesContact: Tamer BoulesTaking people
  • Duke Regional HospitalDurham, United StatesContact: Jennifer RymerTaking people
  • Duke University Medical CenterDurham, United StatesContact: Jennifer RymerTaking people
  • Texas Tech University Health Sciences El PasoEl Paso, United StatesContact: Debarata MukherjeeTaking people
  • University of Florida - GainesvilleGainesville, United StatesContact: Samir ShahTaking people
  • Moses Cone HospitalGreensboro, United StatesContact: Franck Azobou Tonleu, MDTaking people
  • North Dallas Research AssociatesMcKinney, United StatesContact: M. Akram Khan, MDTaking people
  • Medical College of WisconsinMilwaukee, United StatesContact: Mitchell DyerTaking people
  • Vanderbilt University Medical CenterNashville, United StatesContact: Aaron AdayTaking people
  • Yale School of MedicineNew Haven, United StatesContact: Carlos Mena-HurtadoTaking people
  • Mount SInai Medical CenterNew York, United StatesContact: Daniella Kadian-Dodov, MDTaking people
  • Rutgers UniversityNewark, United StatesContact: Karim SalemTaking people
  • Sentara Norfolk General HospitalNorfolk, United StatesContact: David DexterTaking people
  • Duke Raleigh HospitalRaleigh, United StatesContact: Jennifer RymerTaking people
  • Mayo ClinicRochester, United StatesContact: Stanislav HenkinTaking people
  • University of Washington Medical CenterSeattle, United StatesContact: Jake HemingwayTaking people
  • Tampa General HospitalTampa, United StatesContact: Sashi InkolluTaking people

About the trial

What the trial wants to find out

The Low dose ColchicinE in pAtients with peripheral Artery DiseasE to address residual vascular Risk (LEADER-PAD) trial will evaluate if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.

The 2 groups in the trial

  • ColchicineExisting treatment, for comparison

    Colchicine 0.5mg daily for the duration of the trial

    Treatment: Colchicine 0.5 MG Oral Tablet

  • Colchicine-PlaceboPlacebo, for comparison

    Colchicine-Placebo daily

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk: A Randomized Trial
Plain-language title
Testing Low-Dose Colchicine for People With Peripheral Artery DiseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
5 October 2026