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Intermittent Claudication clinical trials

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NCT ID: NCT05111379 Recruiting - Clinical trials for Peripheral Arterial Occlusive Disease Fontaine Stage IIa

Acute Local Metabolomic Alterations in Blood and Muscle Tissue in Intermittent Claudication

Start date: January 28, 2022
Phase:
Study type: Observational

The most common clinical presentation of lower extremity arterial disease is intermittent claudication. Current understanding of the pathophysiology of intermittent claudication, as well as its treatment options are limited. The progression of the disease may lead to lower limb amputation, which is devastating for patients' quality of life and is a huge socio-economic burden to society. Current study allows to determine the acute local metabolomic alterations in the ischaemic limb of the patient with intermittent claudication, and investigate the associations between the metabolomic alterations and the patient's maximal walking distance. This provides potentially valuable insight into the pathophysiology of this disease, and helps lay the groundwork for identifying potential novel targets for instituting more effective therapies for this high-risk population.

NCT ID: NCT05059899 Completed - Clinical trials for Peripheral Artery Disease

Home-based Circuit Training for People With Intermittent Claudication

WALKSTRONG
Start date: May 9, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to assess the feasibility of undertaking a randomised controlled trial investigating the effectiveness of a 12-week home-based exercise programme for people with intermittent claudication.

NCT ID: NCT05029739 Active, not recruiting - Clinical trials for Intermittent Claudication

An E-health Intervention for Patients With Peripheral Artery Disease

I-PAD
Start date: October 12, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04925219 Recruiting - Clinical trials for Peripheral Arterial Disease

REmotely Supervised Exercise Therapy Trial 2

RESET2
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Supervised exercise for intermittent claudication is a first line therapy for peripheral arterial disease, as recommended by the National Institute for Health and Clinical Excellence and the European Society for Vascular Surgery. However 2/3 of British trusts cannot implement this due to gym availability, costs, travel time and the requirement for social distancing. During the COVID-19 lockdown the investigators successfully performed a feasibility study for remotely supervised exercise using an electronic walking log and fortnightly video calls with a physiotherapist. RESET2 aims to compare the benefits of and adherence to remotely supervised exercise with self-directed exercise to absolute walking distance.

NCT ID: NCT04912323 Recruiting - Clinical trials for Peripheral Arterial Disease

Study of the R3 Vascular Drug-Eluting Bioresorbable Scaffold in Treating Below the Knee Arterial Disease

RESOLV I
Start date: August 17, 2021
Phase: N/A
Study type: Interventional

This first-in-human clinical feasibility study will evaluate the safety and performance of the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold and Delivery System in patients undergoing treatment for peripheral arterial disease severe enough to have significantly reduced the blood supply to their leg. The severe reduction in blood flow causes lifestyle limiting leg pain for these patients, and may lead to amputation of the affected limb due to the loss of tissue in the leg or foot from ulcers or gangrene. The investigational device being studied in this trial is intended to restore blood flow to the affected limb, providing symptomatic relief to the patient and reducing the risk of limb amputation. The scaffold is a type of vascular stent placed within the diseased artery below the knee to improve blood flow. Unlike commercially available metallic stents which are permanently placed within the artery, the MAGNITUDE® Bioresorbable scaffold is made of a polymer material that will completely dissolve away over time, providing the support necessary to the artery while it is healing after the treatment procedure and then slowly disappearing from the artery once that support is no longer needed. The investigational scaffold has been successfully used to treat vascular blockages in the coronary arteries of the heart, but the RESOLV I study will be the first time this device has been used to improve blood flow in the arteries of the lower leg. Patients enrolled in this study may have up to three vascular blockages in their lower leg arteries treated with the MAGNITUDE® Bioresorbable scaffold, and then will be assessed over the course of the following five years to evaluate whether the investigational treatment was successful in safely alleviating their leg pain and other symptoms.

NCT ID: NCT04853719 Completed - Clinical trials for Peripheral Artery Disease

Rivaroxaban 2.5 mg BID and Aspirin for Intermittent Claudication in PAD Patients

Start date: April 20, 2021
Phase: Phase 4
Study type: Interventional

This trial is evaluating if rivaroxaban 2.5 mg BID and aspirin 100 mg OD compared to aspirin alone improves on intermittent claudication distance in PAD patients.

NCT ID: NCT04832308 Withdrawn - Clinical trials for Peripheral Artery Disease

Mobile Intervention Supervised Exercise Therapy Study 1

MiSET-1
Start date: August 20, 2021
Phase: N/A
Study type: Interventional

This is a randomized controlled trial evaluating the impact of the mobile phone delivered SVS SET Program on utilization, functional capacity, symptoms and quality of life.

NCT ID: NCT04800692 Recruiting - Clinical trials for Peripheral Artery Disease

The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication

ATLAS
Start date: June 15, 2021
Phase: Phase 1
Study type: Interventional

This study will focus on people with claudication from peripheral arterial disease. The investigators are researching whether a multicomponent therapeutic can increase the production of Nitric Oxide in the blood and whether that leads to an improvement in pain free walking distance and overall physical activity.

NCT ID: NCT04749732 Recruiting - Clinical trials for Intermittent Claudication

Home-based Exercise Therapy for Patients With PAD

WalkingPAD
Start date: February 9, 2021
Phase: N/A
Study type: Interventional

Cardiovascular disease represents a considerable economic burden to society and effective preventive measures are necessary. Patients with peripheral arterial disease (PAD) have a severe impairment of functional ability, namely in walking distance due to muscle ischemia defined as intermittent claudication (IC). The discomfort related to IC contributes to a sedentary lifestyle, decreasing physical fitness level, aggravating cardiovascular risk factors leading to disease deterioration. Exercise programs are an effective, low-cost, low-risk option compared with more invasive therapies for IC. Home-based exercise therapy (HBET) is structured, unsupervised, self-directed programs that take place in the personal setting of the patient rather than in a clinical setting. HBET program implementation is feasible and eliminates barriers such as transportation issues, proximity to clinics, and conflicts with occupational responsibilities. Even though these programs have shown to be effective at improving walking performance and distance, their results fall below those seen in Supervised Exercise Therapy (SET) programs. Thus, innovative home-based walking programs need to be developed in order to improve results and make exercise therapy available to a larger percentage of the population. The use of Information and communication technology (ICT) tools for self-monitoring is considered key to change long-term behavior. The WalkingPAD project aims to develop health technology assessment methods and evaluate personal health intervention strategies. Investigators intend to demonstrate the technical feasibility and economic viability of a personalized medicine application in real-life healthcare settings. This project intends to find evidence for three major questions: Does an M-health monitored home-based exercise program supported by a virtual assistant empowers commitment to exercise plan and allows remote control of plan accomplishment? Is it superior to an M-health monitored home-based exercise program supported by a behavioral motivational intervention, in increasing maximum walking distance? Is it superior to a self-monitoring exercise, with a specific self-designed walking plan in the residence area, in increasing maximum walking distance?

NCT ID: NCT04586725 Not yet recruiting - Clinical trials for Intermittent Claudication

Effect of Encouragement on Six Minute Walk Test Performance

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Peripheral artery disease (PAD) is characterised by a build up of fatty plaque in the arteries in the lower limbs, resulting in a reduction of blow flow to the muscles. Globally, it is estimated that 236 million people are living with PAD. A classic symptom of PAD is intermittent claudication (IC) which is characterised by muscle cramps in the lower limbs, typically brought on by exercise and relieved at rest. Exercise is recommended at first line treatment for IC. However to assess IC symptoms in response to an exercise study, maximal walking capacity (the furthest they can walk before it becomes too painful to walk) is typically the main measure. A patients walking capacity is assessed by a number of exercise testing protocols including the six-minute walk test (6MWT), where patients walk for six minutes with the aim to walk as far as they can in the time allotted. Patient encouragement has been shown to improve walking performance by as much as 30 meters in heart failure and respiratory disease populations. However the effect of encouragement on walking performance in people with IC is yet to be studied.