Active clinical trials for "Intermittent Claudication"

To investigate in patients suffering from intermittent claudication due to Fontaine stage II PAD whether a 24-week treatment by SL650472 OD on top of clopidogrel may result in an improvement of walking capacity, by comparing three doses of SL650472 to placebo, and to calibrate such effect versus cilostazol

Studies have shown that intermittent negative pressure (INP) can induce short-term increase in blood flow in the extremity in patients with peripheral artery disease (PAD). Case reports also have indicated that INP treatment has beneficial hemodynamic and clinical effects in patients with lower limb ischemia and hard to heal leg ulcers. However, the clinical and physiological effects of long-term INP treatment are not well documented and needs further investigation.

In this controlled trial, patients with peripheral arterial disease will be randomized to either maximal walking, submaximal walking, or usual care groups.

This study will assess the adjuvant benefit of a neuromuscular electrical stimulation device to standard treatment of supervised exercise in patients suffering from symptoms and effects of lower limb Intermittent Claudication.

The aim of the study is to evaluate whether walking capacity in patients with intermittent claudication is improved more by home-based 5+ exercise training than by current recommendations of daily walking. The study will elucidate if such a potential effect is dependent on changes in mitochondrial respiratory capacity, blood flow or both.

Peripheral arterial disease (PAD) due to lower limb arterial blockages affects significant proportion of the population with an age-adjusted prevalence of approximately 12%. Claudication induced walking impairment can be debilitating and adversely affects social, leisure, and occupational activities in many patients and is associated with higher mortality among PAD patients. Unfortunately, very few effective therapies are available to improve leg symptoms and exercise performance in PAD patients. Surgery is the last resort but results vary. Therefore, there is a large unmet need for medical therapies that can improve long-term walking performance and functional capacity in PAD patients. Danshen and Gegen (D&G) are commonly used Chinese herbal medicine in the treatment of cardiovascular diseases. D&G study has been extensively researched and continued at The Chinese University of Hong Kong (CUHK) for their antioxidative and vasodilator properties, modulate anti-atherosclerosis and improve arthrogenic athophysiology. Three randomized trials were completed at the CUHK showing D&G improved lipid profile, vascular function and thinned down the internal layer of the carotid artery. One may expect the same with lower limb arteries. Extensive clinical experiences of use in China and Hong Kong indicated that D&G are well tolerated and safe. This project is a randomized control trial to determine the efficacy and Safety of D&G in improving the functional capacity & QoL in patients with symptomatic PAD. The results of this study have the potential to change local and international practice in providing a much needed therapeutic option in the treatment of PAD.

To evaluate the effects of HPIPC for the treatment of symptoms of PAD

The purpose of this study is to evaluate the change in Walking capacity after an intake of caffeine. The study design is cross-over and follow-up of 80 patients with leg pain caused by narrowing of their leg arteries, Peripheral Vascular Disease (PAD), stage II. Half of all will be revascularised, follow up will be after 3 months. It is hypothesized that caffeine (6mg/kg) can be a cheap, safe drug before walking exercise. Primary endpoint is maximum walking distance (MWD), treadmill-testing,(constant load, 0%,2m/h). Secondary endpoints are pain free walking distance (PWD), maximum muscle strength, endurance, reaction speed, balance, cognitive function, health related quality of life (SF-36).

This study will test the safety of a drug called EW-A-401 in patients with intermittent claudication - pain and discomfort in the legs due to blockages of the arteries. The study will also evaluate whether EW-A-401 improves blood flow to the legs. EW-A-401 contains genetic material (DNA) that instructs the body to produce specific proteins that promote the growth of new blood vessels and may, therefore, improve blood flow to the legs. Patients 21 years of age and older with pain or discomfort of one or both legs due to blockages of the arteries below the groin may be eligible for this study. Candidates are screened with a medical history, physical examination, blood and urine tests, eye examination, chest x-ray and CT scan of the chest, and treadmill tests. Patients who are able to exercise more than 12 minutes on the treadmill may not enroll in the study. Participants undergo the following procedures: Muscle biopsy: On the first day of the study, patients have a muscle biopsy. This procedure is done under local anesthesia with mild sedation. A 1-inch incision is cut into the skin over a calf muscle and a small amount of muscle tissue is removed for examination by a pathologist. Drug treatment and tests: About 10 to 13 days after the biopsy, patients are admitted to the NIH Clinical Center for 3 to 5 days for drug treatment and tests. They receive 10 injections of either the study drug (EW-A-401) or placebo (an inactive substance) in each leg during a single session lasting about 1 hour. In addition, they have blood and urine tests, complete questionnaires about their symptoms, and undergo magnetic resonance imaging (MRI), a test that a magnetic field and radio waves to produce detailed images of body tissues and organs. For this procedure, the patient lies on a table that slides into the scanner (a large hollow tube) for imaging of the blood vessels in the legs. Patients wear headphones to muffle loud knocking and thumping sounds that occur during the scanning process. 30-day follow-up: Patients return to the Clinical Center three times over 30 days following the hospital stay for a medical history, physical examination, and blood and urine tests to assess the safety of EW-A-401. Extended follow-up: Patients return to the Clinical Center at 3, 6, and 12 months after hospitalization for a medical history and physical examination, blood and urine tests, two treadmill tests, questionnaires about symptoms, and MRI studies, including imaging for blood flow measurement. Blood flow to the legs is measured during MRI using large blood pressure cuffs inflated around the legs during the scanning. The cuffs are inflated very tightly for 5 minutes, and then a dye is injected into an arm vein to brighten the images. Additional pictures are taken over the next 5 to 10 minutes. At two of these follow-up visits, patients also have an eye examination, and at the 3- or 6-month visit they have a repeat muscle biopsy of the calf. The study lasts 12 months. After 6 months, patients will be told whether they received EW-A-401 or placebo. Because EW-A-401 is so new, patients will continue to be contacted every year after the study is completed.

The purpose of this study is (1) to determine whether a 3-month exercise rehabilitation program will improve claudication distances, free-living daily physical activity, and health-related quality of life of older, revascularized patients with peripheral arterial disease, and (2) to determine whether the primary mechanisms by which exercise rehabilitation affects the above functional outcomes are through alterations in walking efficiency, peripheral circulation, and cardiopulmonary function.