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Intermittent Claudication clinical trials

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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: NCT03512912 Recruiting - Clinical trials for Peripheral Arterial Disease

Transcutaneous Electrostimulation for Intermittent Claudication Supervised Walking Therapy for Intermittent cLAudication

TESLA
Start date: May 2018
Phase:
Study type: Observational

Prospective mono-centric trial on patients with peripheral arterial disease and intermittent claudication that receive supervised exercise therapy (group 1) vs. supervised exercise therapy + daily transcutaneous electro-stimulation of the calf muscles.

NCT ID: NCT03238222 Recruiting - Clinical trials for Peripheral Arterial Disease

Motivating Structured Walking Activity in Intermittent Claudication

MOSAIC
Start date: November 10, 2017
Phase: N/A
Study type: Interventional

Peripheral arterial disease can cause leg pain or discomfort (called intermittent claudication (IC)), which limits the ability to walk and carry out everyday activities. Lifestyle changes, like increasing walking, can lead to improvements, but can be a challenge to begin and then continue. The aim of this study is to investigate if a physiotherapist-led, behaviour change treatment effects walking in people with IC. The treatment is designed to build an understanding of IC and walking exercise and help individuals develop strategies to increase regular walking. The trial will recruit 192 adults (aged 50 years and over) with IC. All participants will visit King's College London or their local hospital to complete two short walking tests and answer questionnaires about their daily activities, beliefs about their symptoms and treatment, quality of life and the costs of having IC. Participants will then be randomly assigned to receive either the new treatment or continue with their usual NHS care. The new treatment involves two 60-minute face-to-face sessions (at the participant's home or local hospital) and two 20-minute telephone calls with a physiotherapist who will discuss participants' understanding and beliefs about IC, walking and help participants to set goals and plans to increase walking over 12 weeks. Participants will be provided with a step counter (pedometer) and walking record. After 12 weeks, all participants will attend a second appointment where they will repeat the walking tests and fill out another set of questionnaires. A final set of questionnaires will be completed by all participants after 6 months (by post or electronically). Some participants will be invited to provide feedback on their experience of the treatment and trial by telephone or a face-to-face interview with a researcher.

NCT ID: NCT03203239 Recruiting - Clinical trials for Peripheral Artery Disease

Red Light Treatment in Peripheral Artery Disease

Start date: January 17, 2018
Phase: N/A
Study type: Interventional

Subjects with a known diagnosis of peripheral artery disease as measured by an abnormal ankle brachial index (<.9 or >1.1) will undergo a single 5 min exposure of 670 nm light, 1 cm above the gastrocnemius muscle. Blood flow will be measured by infusion of ultrasound contrast and subsequent acquisition of ultrasound images. 2 blood samples will be collected for measurement of nitric oxide metabolites.

NCT ID: NCT03048890 Recruiting - Clinical trials for Peripheral Artery Disease

VascTrac Peripheral Arterial Disease (PAD) Study

VascTrac
Start date: March 1, 2017
Phase:
Study type: Observational

VascTrac is a mobile medical application that tracks users' physical activity levels in order to predict endovascular failure of patients with Peripheral Artery Disease.

NCT ID: NCT02993874 Recruiting - Clinical trials for Intermittent Claudication

Creatine Supplementation in Patients With Intermittent Claudication.

Start date: June 26, 2017
Phase: N/A
Study type: Interventional

The aim of this study will be to verify the effect of creatine supplementation associated to clinical treatment of the functional capacity in patients with intermittent claudication.

NCT ID: NCT02842424 Recruiting - Clinical trials for Peripheral Arterial Disease

Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis

Start date: February 25, 2016
Phase: Phase 4
Study type: Interventional

Peripheral artery disease (PAD) is a manifestation of atherosclerosis that produces progressive narrowing and occlusion of the arteries supplying the lower extremities. The most common clinical manifestation of PAD is claudication, i.e., a severe functional limitation identified as gait dysfunction and walking-induced leg muscle pain relieved by rest. The standard therapies for claudication include the medications cilostazol and pentoxifylline, supervised exercise therapy and operative revascularization. Recent data demonstrated that 24 weeks of treatment with the angiotensin-converting enzyme (ACE) inhibitor Ramipril produces improvements in the walking performance of patients with claudication that are higher than those of cilostazol and pentoxifylline and similar to those produced by supervised exercise therapy and operative revascularization. The mechanisms by which Ramipril therapy produces this impressive improvement in the functional capacity of claudicating patients remain unknown. The Investigators hypothesize that treatment of claudicating PAD patients with Ramipril will improve walking performance and quality of life by improving the myopathy of the gastrocnemius. Improved myopathy is a consequence of reduced oxidative damage, reduced TGF-β1 production by vascular smooth muscle cells and reduced collagen deposition in the affected gastrocnemius.

NCT ID: NCT02510807 Recruiting - Clinical trials for Intermittent Claudication

The PaWS (Pedometer and Walking Study)

PAWS
Start date: July 2015
Phase: N/A
Study type: Interventional

The literature has shown that supervised exercise programs for patients with PAD and who report intermittent claudication (IC) have improved health outcomes, but this is not locally available. Introducing the use of a pedometer may act as a method to encourage patients to continue on their independent exercise regimen. There is very little literature which has examined the effectiveness using pedometers as a measure of compliance within this population.

NCT ID: NCT02389023 Recruiting - Clinical trials for Peripheral Artery Disease

Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery

Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of negative pressure incision management system (Prevena™ Incision Management System (PIMS) or ActiVAC® with the Prevena™ Dressings (Peel and Place™ or Customizable™), KCI) in the prevention of wound complications including surgical site infection (SSI) and non-infectious complications in patients undergoing vascular surgery with groin incisions.

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.