Peripheral Arterial Disease Clinical Trials

In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes. The objective of this study is to conduct a pilot randomized clinical trial (RCT) to evaluate the impact of using remotely collected patient generated health data (PGHD) from older patients undergoing bypass surgery due to chronic limb threatening ischemia. The hypothesis is that integrating PGHD with an EHR system will help providers manage post-surgical symptoms and thus improve post-operative mobility and quality of life health outcomes. Read Less

A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System. Read Less

This is a prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System). Read Less

The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of endpoints, including target lesion revascularization and health status, to enable future planning of comparative effectiveness research. Read Less

The purpose of the current study is to conduct a proof-of-concept test regarding the delivery of a Mind Body Program for vascular disease, focusing on support for depression, stress, and adherence, as part of patients' chronic disease management for peripheral artery disease (PAD). Read Less

The objective of this trial is to determine if Near-infrared spectroscopy (NIRS) can accurately evaluate the degree of Peripheral Arterial Disease (PAD) during a Provocative Elevation Maneuver of the Lower Extremity (PEMLE) test, as compared to routine clinical assessments. Read Less

The investigators will test the efficacy of the novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System for use in caring for patients with surgically closed wounds. The investigators hypothesize that using this novel oxygen diffusion dressing will reduce the likelihood of necrotic tissue as well as severe incisional scar post-surgical closure by improving transcutaneous oxygen levels during wound healing process. TransCu O2 Oxygen Delivery System is a novel wound healing therapy that promises to enhance tissue hydration, which in turn may lead to quick epithelialization essential to reduce the likelihood of formation of necrotic tissue and excessive scars. Read Less

The purpose of this study is to determine the best assistance level of an exoskeleton footwear (EF) that can assist walking for people older than 40 with and without peripheral artery disease (PAD). The test will be performed on two different groups of people for this study that include: 1) people with PAD, and 2) individuals who don't have PAD. Data will be collected from 50 healthy older individuals and 25 patients with PAD, both groups will be 40 years or older. Gait biomechanics, muscle oxygenation, and energy cost for seven different walking conditions including normal walking, walking with EF with no assistance, and walking with EF with 5 different levels of assistance will be collected from the healthy older individuals. Additionally, subject-reported outcomes after each walking conditions including perceived comfort and fatigue, rate of perceived exertion and feasibility of the EF will be collected. Gait biomechanics, muscle oxygenation, energy cost, and patient-reported outcomes will be measured in patients with PAD for four walking conditions including normal walking, walking with EF but no assistance, walking with EF with the best two assistance levels. Subjects will be allowed to acclimate to the EF prior to recording data. All patients with PAD will participate in feasibility interviews that will assess acceptability, demand, implementation, and practicality. All subjects will be asked to fill out questionnaires that assess quality of life, physical function, and the ability to complete activities of daily living. Read Less

Patient Power is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), other musculoskeletal conditions, chronic neurological conditions like migraine, chronic pulmonary conditions like Chronic Obstructive Pulmonary Disease (COPD), asthma, autoimmune dermatological conditions such as psoriasis, and other chronic inflammatory or immune-mediated conditions. In addition, since patients with chronic conditions often have other co-morbidities like cardiovascular health and obesity-related metabolic disorders, these conditions will also be included. Participants will provide information from their smartphones or personal computers. The information will be used by researchers and clinicians to help patients and their providers make better, more informed decisions about treatment of chronic conditions. Read Less

Peripheral arterial disease (PAD) is a highly prevalent and costly condition. Intermittent claudication (IC), defined as ischemic leg pain that occurs with walking, results in functional impairment, reduced daily physical activity, and a lower quality of life. Although the mechanisms contributing to functional impairment are not fully delineated, current evidence suggests that the uncoupling of skeletal muscle cellular metabolism from tissue perfusion may be responsible for exercise intolerance. We have previously shown increases in plasma inorganic nitrite, via oral nitrate, produced clinically significant increases exercise performance in patients with PAD+IC. The hypothesis of this proposal is in patients with PAD+IC, 3-6 days of oral dietary nitrate consumption (in the form of concentrated beetroot juice) will produce a greater tissue perfusion, oxygen delivery, and enhanced muscle metabolism in comparison to placebo. This will translate into an increase in physical performance in both muscle specific plantar flexion exercise and treadmill measures of pain free ambulation. In order to test this hypothesis, we will recruit 10 patients PAD+IC in a randomized, double-blind, placebo controlled, cross over design. Read Less

The purpose of the study is to determine associations between fitness status, bacteria in the mouth, and the blood flow to muscle. This study is trying to find out if fitness status impacts the bacteria that are present in the oral microbiome (environment in the mouth) or the ability of the body to send blood to the skeletal muscle. Participants will complete all or some of the following: A mouth swab to assess the bacteria in their mouths. Produce a saliva sample into a tube. Cycle on a bike until you reach maximum effort. Undergo blood draws Wear a 24-hour non-invasive device that monitors blood pressure. Undergo a test to assess blood flow to the muscles measured with an ultrasound. Drink 70mL (1/3 of a cup) of concentrated beetroot juice once Read Less

The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease. Read Less