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Intermittent Claudication clinical trials

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NCT ID: NCT01776710 Completed - Clinical trials for Peripheral Arterial Disease

Structured EDucation for Rehabilitation in Intermittent Claudication

SEDRIC
Start date: April 2013
Phase: N/A
Study type: Interventional

A primary therapeutic goal for patients with intermittent claudication (IC) is to regain lost physical function through exercise rehabilitation. Supervised exercise programmes can markedly improve walking capacity, but these are resource intensive, National Health Service provision is limited, and patients cite accessing services as a barrier to participation. Increasing walking activity via a structured education programme might be a pragmatic solution for improving walking capacity, health and wellbeing in patients with IC; however, further research is needed to substantiate this. Hence, the aim of this project is to develop a pragmatic education programme to increase walking in these patients and to collect data on its feasibility to inform the development of a definitive trial investigating clinical and cost effectiveness. Focus groups will be conducted to inform the development of the education programme. Programme components will be theoretically-underpinned and evidence-based. The development of the programme will be an iterative process involving pilot work, feedback, evaluation, and revision. The programme will then be assessed in a randomised controlled pilot study with 6-week follow-up (n=30). We will assess the feasibility of the intervention and obtain preliminary data of its impact on important outcomes (daily steps/physical activity, walking capacity, quality of life, illness perceptions).

NCT ID: NCT01738542 Completed - Clinical trials for Peripheral Arterial Disease

Safety and Efficacy Study of Bosentan for Intermittent Claudication in Peripheral Arterial Disease

CLAU
Start date: April 2009
Phase: N/A
Study type: Interventional

A prospective study, proof-of concept, randomized, controlled, parallel groups, simple blind was performed in 30 male patients (50-60 years old) with Intermittent Claudication (Rutherford category 1-2) recently diagnosed and clinical manifestations not exceeding 6 months with hypertension and/or dyslipidemia as unique co-morbility disorders. After a period of stabilization of the claudication distance in the Stress test (12.5%, 3.2 km/h) during 2 weeks, were randomized 1:1 to the experimental arm (Bosentan 62.5 mg twice daily/four weeks and 125 mg twice daily/eight weeks) or control group.

NCT ID: NCT01734603 Completed - Clinical trials for Peripheral Arterial Disease

Intensive Rehabilitation in Peripheral Arterial Disease With Claudication: Effects of a Treadmill Training With Active Recovery

ARTEX
Start date: October 2011
Phase: Phase 3
Study type: Interventional

Rehabilitation is the first intention treatment of peripheral arterial disease (PAD) with claudication. Initially proposed in the sixty's, rehabilitation programs dedicated to patients with PAD have recently been proved effective and defined in many guidelines. Supervised walking training on treadmill is recommended. Usually patients walk up to a mild or moderate pain (evaluated at 3 or 4 on the claudication pain scale; maximum pain =5), then stop until pain completely subsides and walk again . The Artex study assesses the efficacy of a fractionated mode of training avoiding pain by alternating short sequences of intensive training and active recovery (without rest).

NCT ID: NCT01679990 Completed - Clinical trials for Peripheral Artery Disease

Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)

Start date: November 5, 2012
Phase: Phase 2
Study type: Interventional

The objective of the study is to establish the safety profile of Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects comprising of 4 treatment groups: 1. Double treatment of PLX-PAD low dose 2. Double treatment of PLX-PAD high dose 3. Double treatment of Placebo 4. Single treatment of PLX-PAD high dose and additional treatment of Placebo. Subjects will receive the assigned treatment twice to the affected leg, within 12-weeks interval between each treatment. The study will be comprised of 5 stages: Screening period of up to 4 weeks,first treatment of PLX-PAD or placebo followed by additional injection after 12 weeks and with follow-up of 12 months post second injection

NCT ID: NCT01602159 Completed - Claudication Clinical Trials

Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)

ROBUST
Start date: July 2009
Phase: N/A
Study type: Interventional

This is a prospective randomized controlled trial to compare clinical improvement, cost effectiveness and patency rates between new and improved Nitinol stents and open bypass surgery in the superficial femoral artery disease. Secondary outcomes also include comparing quality of life, re-intervention rate, mortality, morbidity and time to return to work or regular activities. Patients with superficial femoral artery lesions will be considered. Patients with TASC II A lesions will not be randomized but treated with PTA/stenting as standard of care. Patients with TASC II B and C lesions will be prospectively randomized into either receiving open bypass or stenting. Patients with TASC D lesions will be treated with open bypass surgery after angiography. The investigators will collect pre-procedure, peri-procedural and clinical follow-up data on all enrolled the patients.

NCT ID: NCT01484509 Completed - Clinical trials for Intermittent Claudication

Subjective and Objective Methods of Assessing Walking Limitation Due to Claudication

Start date: June 2011
Phase: N/A
Study type: Observational

Leg artery disease is a common condition in which fatty deposits develop in the blood vessels that supply the legs. Many patients with leg artery disease experience a cramp-like leg pain during walking that is relieved by rest; this is called intermittent claudication. To help determine the severity of leg artery disease, patients may be questioned about how far they can walk before claudication pain forces them to stop. However, this information is usually of limited use because most patients poorly estimate their walking capacity. The investigators have developed a simple questionnaire to help estimate walking capacity in patients with leg artery disease. The purpose of this study is to test the validity and reliability of this questionnaire. By validity, the investigators mean the extent to which the questionnaire measures what it is supposed to measure (walking capacity). By reliability, the investigators mean the extent to which the questionnaire produces the same results over time when completed on two different days. The investigators hypothesise that the investigators simple questionnaire will be valid and reliable.

NCT ID: NCT01468974 Completed - Atherosclerosis Clinical Trials

ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System

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

The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.

NCT ID: NCT01420289 Completed - PVD Clinical Trials

Effect of HPIPC for the Treatment of Ischemic Ulcers in Subjects With PAD

Start date: January 2009
Phase: N/A
Study type: Interventional

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

NCT ID: NCT01366482 Completed - Clinical trials for Peripheral Arterial Disease

Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease

DEFINITIVE AR
Start date: July 2011
Phase: N/A
Study type: Interventional

The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease.

NCT ID: NCT01263925 Completed - Clinical trials for Stage II Peripheral Arterial Occlusive Disease

Prostaglandin E1 in Outpatients With Intermittent Claudication

Start date: April 2001
Phase: Phase 3
Study type: Interventional

Investigate, under outpatient conditions, both the effect of 4 weeks of daily treatment with Prostaglandin E1 and that of 4 weeks of interval treatment (two infusions per week) on the pain-free walking distance in patients with Intermittent Claudication.