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Intermittent Claudication clinical trials

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NCT ID: NCT03811925 Recruiting - Clinical trials for Peripheral Arterial Disease

SFA TReatment and vAscular Functions

STRAtiFy
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Endovascular treatment of the superficial femoral artery has a high initial success rate, but restenosis occurs in up to 60% of cases. While restoration of tissue perfusion is achieved, interventional strategies affect endothelial function. Endothelial dysfunction is the pathophysiologic principle involved in the initiation and progression of arteriosclerosis. The aim of this study is to determine the impact of endovascular strategies in the superficial femoral artery on local and systemic endothelial and vascular function.

NCT ID: NCT03784729 Recruiting - Clinical trials for Lumbar Spinal Stenosis

Efficacy of Acupuncture for Lumbar Spinal Stenosis

Start date: March 25, 2019
Phase: N/A
Study type: Interventional

Degenerative lumbar spinal stenosis (DLSS) is a condition which there is narrowing space of sagittal diameter of spinal canal or nerve root canal for spinal nerve or cauda equina secondary to degenerative changes. DLSS is a common cause of gluteal or lower extremity pain, women and elderly people aged 60-70 are more likely to have DLSS. The early symptoms of this disease are soreness and pain in the low back, gluteal region and posterior region of thighs which can be relieved after resting or changing posture. Being accompanied with gradually aggravated symptoms, patients with DLSS may have neurogenic claudication with hypoesthesia and numbness in lateral lower legs and feet, additionally, few patients may have bowel and bladder disturbances. In accordance of the guidelines of North American Spine Society (NASS), treatment options comprise surgical therapy, epidural steroid injections and physical therapy and transcutaneous electrical stimulation, however, the long-term efficacy of surgery is not superior to that of non-surgical therapy. Moreover, the short-term efficacy of non-surgical therapy is with insufficient evidence. According to a systematic review and recent studies, acupuncture may improve the symptoms of patients and their quality of life, however, there is a lack of placebo-controlled and large sample sized study.

NCT ID: NCT03730623 Enrolling by invitation - Clinical trials for Intermittent Claudication

Cross-sectoral Rehabilitation for Patients With Intermittent Claudication

Start date: December 5, 2017
Phase: N/A
Study type: Interventional

Exercise training combined with other lifestyle changes are essential elements in conservative management of patients with Intermittent Claudication (IC). IC is essentially caused by atherosclerosis, which reduces blood flow to the legs and leads to cramping leg pain when walking. Patients suffering from IC may have difficulty in exercising and changing lifestyle without systematic intervention despite the risk of morbidity, mortality and hospitalization. Today, rehabilitation programs, including supervised exercise, exist for patients suffering ischemic heart disease but not for patients with IC, despite evidence that exercise therapy is highly beneficial for patients suffering IC. The overall aim of the present study is to examine the effect of conservative management of patients with IC provided as a three month, cross-sectoral exercise and lifestyle intervention program based on the already established cardiac rehabilitation program. Outcome will be assessed on walking distance and secondly on lifestyle changes and patient reported outcomes. Implications: The project will provide evidence for the effect of cross-sectoral collaborative conservative management of patients with IC, using the existing rehabilitation program already offered to patients suffering ischemic heart disease. Moreover, it will elicit knowledge on patient perceptions of conservative management of IC provided as a proactive cross-sectoral intervention and ways to support patients with IC in adhering to conservative management.

NCT ID: NCT03686306 Recruiting - Clinical trials for Peripheral Artery Disease

VIRTUOSE : Efficiency of Sildenafil on the Absolute Claudication Distance of Peripheral Arterial Disease Patients With Intermittent Claudication.

VIRTUOSE
Start date: November 24, 2021
Phase: Phase 3
Study type: Interventional

Peripheral Arterial Disease (PAD) is a highly debilitating disease that affects 202 million people around the world and about 7 million people in France. Morbi-mortality from cardiovascular events is increased in this population. Intermittent claudication is defined as a discomfort and/or pain in the legs during walking. It is the most common clinical feature of PAD. In claudication, primary therapeutic approach is medical treatment and advice to walk. Revascularization is only proposed when medical treatment and advice to walk for at least 3 to 6 months have failed to improve symptoms and walking ability. Optimal medical treatment includes Antiplatelet, Lipid Lowering Drugs, AT2 antagonists / ACE Inhibitors and advice to walk. To date, no other drug has provided consistent evidence for functional improvement in claudication, except for Cilostazol, a type-3 phospho-diesterase inhibitor (PDEi). This compound has been scarcely used in France due to cost and frequent side effect (Headache, Flush, Diarrhea, etc.) and was withdrawn as a therapy in 2010. Sildenafil, a type 5 PDEi, is well tolerated, largely used in impotence and has interesting clinical delay and duration of action in the concept of a potential use in claudication. Preliminary data from the literature and unpublished case reports, suggest that this drug could efficiently improve symptoms and walking capacity in patients with stage 2 claudication.

NCT ID: NCT03683628 Recruiting - Clinical trials for Intermittent Claudication

Treatment of Intermittent Claudication by G-CSF-mobilized PB-MNC

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with intermittent claudication. Forty PAD patients who presented with intermittent claudication will be randomized into 2 groups. The control group will be treated by medication and walking exercise 3 times/ week. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication and walking exercise 3 times/ week. Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months

NCT ID: NCT03640676 Completed - Clinical trials for Peripheral Arterial Disease

Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Effects After Long-term Treatment

Start date: January 14, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03594344 Recruiting - Diabetes Mellitus Clinical Trials

Additional Hyperbaric Oxygen After Lower Extremity Amputation

AHOLEA
Start date: July 4, 2018
Phase: N/A
Study type: Interventional

This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or control group.

NCT ID: NCT03590769 Completed - Clinical trials for Peripheral Arterial Disease

Arterial Imaging of Inflammation and Resolution After Endovascular Surgery

AIIRES
Start date: June 1, 2017
Phase: Phase 1
Study type: Interventional

This study evaluates the local inflammatory and resolution response of patients undergoing peripheral vascular intervention like an angioplasty of the superficial femoral artery (SFA) or popliteal artery, or stenting of the iliac artery or SFA, through the use of Positron emission tomography-magnetic resonance imaging (PET/MRI). PET/MRI will be performed prior to intervention, one day and one week after intervention.

NCT ID: NCT03564080 Completed - Clinical trials for Coronary Artery Disease

Assessing the Feasibility of Including Patients With Peripheral Artery Disease in to an Established Cardiac Rehabilitation Service.

Start date: July 18, 2018
Phase: N/A
Study type: Interventional

This study will investigate if patients with peripheral artery disease (PAD) can be successfully incorporated into an already existing Cardiac Rehabilitation programme. One group of PAD patients will exercise as a group, and the other group will exercise alongside patients with coronary artery disease (CAD).

NCT ID: NCT03547817 Completed - Clinical trials for Peripheral Artery Disease

Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Optimal Pulse Pressure Regime

Start date: May 15, 2018
Phase: N/A
Study type: Interventional

Recent studies have shown that applying intermittent negative pressure (INP) with short negative pressure (-40 mmHg) pulses to the lower extremities increase arterial blood flow velocity and skin blood flow. However, the optimal magnitude of negative pressure to improve blood flow is not known, and needs further investigation. Peripheral arterial blood flow velocity, skin blood flow and skin temperature in the foot will be recorded at different levels of oscillating negative pressure to identify a pressure range which is practically, while at the same time induce clinically relevant changes in blood flow parameters. Heart rate and blood pressure will be recorded to monitor the effects on the central circulation.