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Intermittent Claudication clinical trials

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NCT ID: NCT02041169 Completed - Clinical trials for Intermittent Claudication

Lower Extremity Peripheral Arterial Disease and Exercise Ischemia

CLASH
Start date: September 2014
Phase: N/A
Study type: Interventional

Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their walking capacity, contributing to an impairment of their quality of life. Despite maintaining a sufficient walking activity is essential for these patients, LEPAD patients lower their physical activity, which worsen the disease and potentially contribute to increase the risk of cardiovascular events and deaths. In a recent study in LEPAD patients, we showed, from a one hour GPS recording, a high variability of the patients' walking capacity (i.e., walking distances between two stops induced by lower limbs pain). Results suggested that in most patients previous stop duration before each walk was a predictor parameter of this walking variability. Whether there is an optimal or minimal recovery time influencing the walking capacity in LEPAD patients has never been studied. This study is a prospective, cross-sectional study in exercise pathophysiology. The main goal is to determine, following a walk that induces ischemia, the influence of the recovery duration on the subsequent walking performance in LEPAD patients. Secondary goals are : 1. To determine the nature of the relationship between the recovery duration and subsequent walking performance. 2. To study the relationship between exercise ischemia, pain evolution and previous recovery duration. 3. To determine whether the experimental procedure influence the determination of an optimal of minimal recovery duration. 4. To study the influence of recovery duration on walking capacity from community-based measurement.

NCT ID: NCT02013193 Completed - Atherosclerosis Clinical Trials

Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries

RANGER-SFA
Start date: January 7, 2014
Phase: N/A
Study type: Interventional

The primary objective of this study is to prove the superior performance of the Ranger™ paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions when compared to non-coated balloons at six months post-procedure when comparing Late Lumen Loss (LLL). Study statistical hypothesis: The %-mean loss of luminal diameter as assessed by angiography at six months follow-up after treatment of the femoropopliteal artery with Ranger DCB study devices is lower than the %-mean loss of luminal diameter after treatment with uncoated PTA balloon control devices.

NCT ID: NCT01980602 Recruiting - Clinical trials for Peripheral Arterial Disease

Effect of Exercise on Patients With Claudication Undergoing Surgery

Start date: March 2011
Phase: N/A
Study type: Interventional

Title: How does exercise improve the calf muscle in patients with poor blood supply to their leg? Purpose of the project: Patients with peripheral arterial disease have a poor blood supply to their lower leg. The reduced inflow prevents the leg from utilising nutrients and oxygen as easily as a healthy leg would. This causes pain when walking (intermittent claudication), which often occurs after a reproducible distance e.g. every 50 yards. These patients have a reduction in their quality of life as they feel embarrassed in social situations e.g. walking around town requires multiple breaks, so they tend to avoid this and isolate themselves more. One treatment for claudication is exercising until the pain comes on; which most are reluctant to do. Walking up to three times a week for an hour, can double most people's walking distances, but doesn't always. The reason why some improve with exercise and others do not remains unknown. This project will be the first randomised controlled trial of exercise in claudicants that focuses on the adaptations that occur in the muscle at a cellular level. We wish to compare muscle cells from a group that have exercised and group that have not. We will focus on the change in muscle cell size and function at present, and later progress to why and how this happens. Methods: We will take measurements at the start of the study (baseline), after 6 weeks and then 3, 6 and 12 months. These measurements will be of a patient's fitness, actual walking distances and blood samples. At the time of surgery, muscle from the calf will be taken from the affected leg. This will be processed at the University's biomedical science department to look at the different types of muscle fibre and how efficiently they are working.

NCT ID: NCT01970332 Completed - Clinical trials for Peripheral Arterial Disease

Mechanisms That Produce the Leg Dysfunction of Claudication & Treatment Strategies

Start date: September 1, 2010
Phase: N/A
Study type: Interventional

Intermittent claudication afflicts 5% of the US population older than 55 years of age and develops along with hardening of the arteries of the legs. Claudicating patients limp and can only walk very short distances because their legs hurt. This protocol evaluates the mechanisms that may produce the leg dysfunction of claudication and its successful completion can ultimately produce significant new diagnostic and treatment strategies for the care of claudicating patients.

NCT ID: NCT01942941 Completed - Varicose Veins Clinical Trials

Peripheral Vascular Disease and Nerve Stimulation

CCLINS
Start date: June 2013
Phase: N/A
Study type: Interventional

A study to see what effect the geko™ device has on blood flow in patients with lower limb vascular disease.

NCT ID: NCT01938391 Completed - Clinical trials for Peripheral Artery Disease

Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

TRUTH
Start date: January 2013
Phase: N/A
Study type: Interventional

IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic peripheral artery disease (PAD) occurring in the Superficial Femoral Artery (SFA), Popliteal (POP), and/or Tibioperoneal Trunk (TPT).

NCT ID: NCT01918826 Recruiting - Clinical trials for CHARCOT MARIE TOOTH DISEASE

Evaluation of the Analgesic Efficiency of the Transcutaneous Neurostimulation in the Charcot Syndrome Marie Tooth on the Pains of Lower Limbs

Start date: June 2012
Phase: N/A
Study type: Interventional

The Charcot syndrome Marie Tooth is the most frequent hereditary neuromuscular diseases: there is no curative treatment at present, on the other hand precautionary measures can be taken (physiotherapy, port of splints, orthopaedic surgery and technical assistants). In the literature and in our recent study (evaluation of the pain in the disease of CMT - Reference center of the neuromuscular diseases - CHU Bow) the frequency of the pain is important varying from 66 to 96 % cases, affecting especially hands and lower limbs. The care of the pain in the Charcot syndrome Marie Tooth is not codified. The transcutaneous neurostimulation(TENS) is a not medicinal and not invasive therapeutics, without any brought back collateral effect, used at the same time in the chronic pain and acute since 1960, as well for the neuropathic pains that musculo-scrawny. No study was realized this day on the use of the TENS with analgesic aim in the CMT. We suggest studying the analgesic efficiency of the TENS in the Charcot syndrome Marie Tooth on the pains of lower limbs, the most frequent painful location in our recent works. The main objective will be to analyze the improvement of the pain of lower limbs, based on the decrease of the analogical visual scale(ladder) (EVA), at least 30 %. The secondary objectives will be to estimate repercussions on the functional capacities ( ONLS), the quality of life (SF(sci-fi) 12), the satisfaction (EVA), the global impression(printing) of change ( PGIC), the consumption of analgesic, DN4, NPSI (Neuropathic Pain Symptom Inventory), Concise Questionnaire of the Pains ( QCD), HAD (Hospital Anxiety and Depression scale).

NCT ID: NCT01890135 Completed - Clinical trials for Peripheral Arterial Disease

Zibotentan, an Endothelin Receptor Antagonist, Patients With Intermittent Claudication

Start date: June 2013
Phase: Phase 2
Study type: Interventional

Peripheral artery disease (PAD) is a major complication of atherosclerosis when blockages in the arteries to leg reduce blood flow and one of the resulting problems is termed intermittent claudication (IC). IC is leg pain with walking that is relieved with rest and IC is the most frequent clinical manifestation of PAD and it effects millions of Americans. The number of patients with, and the health care costs of, PAD will increase as the prevalence of PAD is associated with advancing age, diabetes, and smoking. Zibotentan (ZD4054) is an endothelin receptor A (ETA) blocker that undergone extensive human testing and has been shown to be safe in several patient population. There is ample evidence to suggest that an ETA blocker could improve blood flow to the legs in patients with PAD. In a study that will be funded by the National Institute of Health, the investigators will test the ability of this medication to allow better blood flow to the legs of patients with PAD. In patients with IC, the investigators will test the ability of ZD4054 to improve leg blood flow using a non-invasive imaging technique. In parallel the study will test for the ability of patients with leg pain to walk further and feel better.

NCT ID: NCT01888536 Completed - Clinical trials for Neurologic Claudication in Patients With Lumbar Spinal Stenosis

A Study to Evaluate Efficacy of 『Opast Tablet』for Neurologic Claudication in Patients With Lumbar Spinal Stenosis

Start date: February 2013
Phase: Phase 4
Study type: Interventional

This trial is a comparative study of Opast tablet and Rikalin capsule 75mg and Rikalin capsule 75mg in combination with Opast tablet to evaluate improvement effectiveness of Opast tablet on subjective symptoms and neurologic claudication in patients with lumbar spinal stenosis.

NCT ID: NCT01871779 Completed - Clinical trials for Peripheral Arterial Disease

Effect of Exercise Training on Protein Expression in Skeletal Muscle Tissue After Exercise in Peripheral Arterial Disease

Start date: October 2010
Phase: N/A
Study type: Interventional

Cardiovascular disease remain one of the leading causes of death in Australia, accounting for 47637 (36%) of deaths in 2004. Peripheral arterial disease (PAD) is a category of cardiovascular disease, characterised by intermittent claudication. This is defined as walking induced pain, cramping, aching, tiredness or heaviness in one or both legs that does not go away with continued walking and is relieved with rest. It is estimated that between 5-10% of individuals aged over 50 years suffer from claudication. The primary and most effective treatment for these patients is focused on improving walking ability and functional status. Current research has shown that approximately 30% of patients improve with exercise, while 30% continue to deteriorate and the rest show no change. The changes produced at a biochemical and cellular level due to exercise are unknown. To help better understand this, our study will assess the entire range of proteins expressed before and after exercise in the skeletal muscle tissue of patients with intermittent claudication. This will help to identifying key proteins that have a role in improving patient symptoms and outcome.