View clinical trials related to Intermittent Claudication.
Filter by:The goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an infrainguinal venous bypass stenosis. The main question we aim to answer is, how patency is affected by each of the randomised treatment options.
The specific study aim is to determine whether a 12-week digitally delivered behavior change intervention for patients with peripheral artery disease increases walking ability, reduces smoking, improves quality of life and improves medication adherence. The primary and secondary endpoints will primarily be captured at a 12 weeks follow-up visit, but a follow-up visit after 12 months is also planned; to assess longer term effect on outcomes and healthcare cost.
The aim of the present study is to find out the influence of sarcopenia on outcomes of neuroplasty in patients with lumbar spinal stenosis.
Exercise training improves walking capacity and regional perfusion in patients with Intermittent Claudication (IC). Endothelial Progenitor Cells (EPCs) and Endothelial Microparticles (EMPs) could play an important role in this process, promoting the healing of the diseased endothelium. The investigators are going to measure EPCs and EMPs in a group of patients with IC and in a control group of healthy individuals before a treadmill test and 2, 24, and 48 hours after the test. Subsequently, a group of IC patients will be randomly assigned to perform a 12-week home-based exercise training program. The investigators expect a significant increase of EMPs and EPCs after acute and chronic physical activity. We expect also a correlation between the increase of EMPs and EPCs and the improvement in walking capacity. Aim of the study is to demonstrate that acutely performed aerobic exercise could be able to promote the mobilization of EMPs and EPCs in patients with IC and that endothelial progenitor cells mobilization could play a pivotal role in exercise induced improvement of walking performance and endothelial function in subjects with IC.
This proposed study will be conducted to support real-world-evidence on the extent of best medical treatment for secondary prevention of patients with symptomatic peripheral arterial occlusive disease (PAOD) for prevention of worsening limb symptoms or of major adverse cardiovascular events. The overall objective of this study is to gain a better understanding of patient characteristics, treatment patterns and outcomes in PAOD patients. For this purpose the investigators will analyze a patient population hospitalized either with intermittent claudication (IC) or chronic limb-threatening ischaemia (CLTI) while taking prior PAOD-related diagnoses in the outpatient setting into account. In detail, we study differentials according to age, calendar time, sex, disease severity and hospital procedure. Data were extracted from available German health insurance claims.
The Chocolate Touch study is a randomized, multi-center, prospective, adaptive study, designed to show sufficient safety and effectiveness of the Chocolate Touch™ for use in superficial femoral or popliteal arteries with the intention of obtaining regulatory approval to market this device in the United States
The purpose of this randomized clinical trial is to determine and compare the clinical and cost effectiveness of three methods for exercise therapy as treatment for patients with intermittent claudication. The methods tested are a hospital-based (SET) and a home-based (HET) supervised exercise program and unsupervised walk advice (WA) and all patients are followed for 12 months. Unsupervised WA consists of advice of at least 30 minutes walking with Nordic Poles (NP) at least three times per week and this basic treatment, including best medical treatment, is used in all three treatment groups. In addition to this basic treatment, the SET group patients during the first six months participate in group-based exercise therapy in the hospital for 50 minutes three times weekly, supervised by a physiotherapist. The HET group patients perform the same exercise in their home 50 minutes three times weekly during six months receiving feedback from a physiotherapist by a phone call every 14th day. The SET and HET group patients are recommended to continue the 50 minutes three times weekly exercise therapy in their homes without supervision during the last six months. Primary outcome is change from baseline to 12 months in walking distance during six minutes in a hospital corridor (6MWT) and co-primary outcome is change from baseline to 12 months in health-related quality of life (HRQoL) using the SF36 questionnaire. Secondary outcomes include fulfillment of patient-specified goals with treatment (PSFS), change in health-related quality-of-life (HRQoL) with a disease-specific instrument (VascuQoL), walking impairment as measured by the Walking Impairment Questionnaire, physical activity (accelerometer) and compliance with physical exercise therapy (patient diary).
DVC1-0101 is a gene therapy medicine to treat peripheral arterial disease (PAD) based on recombinant F-gene-deleted, non-transmissible Sendai virus (rSeV/dF) expressing human fibroblast growth factor-2 (FGF-2) gene. The primary objective of the current Phase IIb study is to investigate the clinical efficacy of DVC1-0101 (1x10^9 ciu/leg, 5x10^9 ciu/leg) in patients with IC.
Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk of amputation, to exercise-induced pain (intermittent claudication), limiting the patients daily activities. Invasive treatments are often indicated to prevent amputations and to alleviate symptoms. More than two thirds of these procedures are presently performed with endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without stent implantation). In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents, DES) reduce restenosis and improve clinical results for the majority of patients. Drug eluting balloons (DEB) are a promising alternative, but there is still little evidence that DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing these new technologies in PAD have been reported in a few studies. In this trial, we test the hypothesis that drug eluting (DE) technology is superior to conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each defined by the severity of peripheral arterial disease. Patients with critical limb ischemia are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to SWEDEPAD 2.
The purpose of this study is to find out if aldehyde dehydrogenase bright (ALDHbr) cells taken from a patient's bone marrow can be placed safely, via intramuscular injections, into their affected calf and lower thigh muscles and improve blood flow and/or peak walking time in patients experiencing pain associated with blocked blood vessels in the leg.