Ongoing Clinical Trials for Intermittent Claudication
Currently, there is 1 ongoing clinical trial investigating treatment options for intermittent claudication, a condition characterized by leg pain during walking due to reduced blood flow. This trial is exploring the use of low-dose colchicine to reduce serious cardiovascular risks in patients with peripheral artery disease and is being conducted across multiple European countries.
Clinical trial locations
- Belgium
- Italy
- Netherlands
Study on Low-Dose Colchicine for Patients with Peripheral Artery Disease to Reduce Cardiovascular Risks
This clinical trial is investigating whether a low-dose form of colchicine, a medication typically used to reduce inflammation, can help protect patients with peripheral artery disease from serious cardiovascular complications. Peripheral artery disease occurs when blood vessels outside the heart and brain become narrowed, often leading to reduced blood flow to the limbs and causing symptoms like leg pain during walking.
Main inclusion criteria:
- Must be over 18 years old
- Must have symptoms of peripheral arterial disease in the legs with at least one of the following:
- Experience intermittent claudication with an ankle/arm blood pressure ratio of 0.90 or less, or have an artery narrowed by 50% or more, plus have multiple areas affected by atherosclerosis, diabetes, heart failure, or chronic kidney disease
- Experience rest pain, tissue death, or gangrene with an ankle/arm blood pressure ratio of 0.90 or less
- Have undergone a procedure to restore blood flow, such as bypass surgery
- Have had a leg or foot amputation due to blood flow problems
- Must provide written informed consent to participate
Main exclusion criteria:
- Patients who do not have peripheral arterial disease
- Patients who are not within the specified age range
- Patients who belong to a vulnerable population requiring special protection or care
Focus and goals:
The trial aims to examine how effective and safe colchicine is in lowering the chances of serious events like heart attacks, strokes, or severe issues with blood flow to the limbs that might require medical procedures or amputation. Participants will take either colchicine tablets or a placebo daily and will be monitored throughout the study period. Researchers will track various health outcomes, including heart-related events, hospitalizations, and the need for procedures to improve blood flow. The ultimate goal is to determine whether colchicine can improve quality of life and reduce the risk of serious complications for people living with this condition.
Investigational drug:
The study uses Colchicine Tiofarma 500 microgram Tablets, which are taken orally once daily. Colchicine works by reducing inflammation in the body, which may help prevent vascular complications. It is being investigated for its potential to reduce cardiovascular events such as heart attacks, strokes, and severe limb problems in patients with peripheral artery disease.
Summary
Currently, one clinical trial is actively recruiting patients with intermittent claudication and peripheral artery disease. This trial is being conducted across three European countries: Belgium, Italy, and the Netherlands, indicating a multi-national collaborative effort to address this cardiovascular condition. The focus is on evaluating colchicine, an anti-inflammatory medication, as a potential option to reduce serious cardiovascular risks in this patient population. The trial is open to adults with various presentations of peripheral artery disease, from those experiencing leg pain during walking to those who have already undergone procedures to restore blood flow or have experienced limb amputations.