Active clinical trials for "Peripheral Arterial Disease"

Among patients awaiting cardiac surgery, a significant proportion are patients with severe angina, heart failure (HF) and peripheral atherosclerosis. These factors are predictors of an unfavorable near and long-term prognosis after open cardiac surgery. It is known that the restriction of motor activity in patients with peripheral atherosclerosis and HF leads to loss of muscle mass, as well as to a decrease in its strength and endurance: secondary (disuse) sarcopenia is formed. In patients with peripheral atherosclerosis and HF, the low functional status of skeletal muscles is associated with a poor prognosis, regardless of gender, age, and concomitant coronary artery disease. A number of studies have shown that the deterioration of muscle status before abdominal, orthopedic and vascular surgery interferes with the close results of surgery, increases the number of complications, the length of ICU and in-hospital stay. Thus, sarcopenia serves as an additional factor worsening the prognosis. Therefore, efforts aimed at improving the functional status in patients planning an open cardiosurgical surgery seem to be very justified. Standard preoperative management of patients includes the identification and correction of comorbidities and the optimal medical treatment. The idea of "rehabilitation" means an additional improvement in the functional capabilities of patients awaiting surgery. Prevention includes outpatient outreach and educational work by nurses, as well as preoperative physical exercises. For this, multi-level training is used: respiratory exercises for the patients with the most severe illness, free movements of the limbs without load, or bike or treadmill training with increasing load for tolerable patients. However, adequate physical rehabilitation is difficult particularly on an outpatient basis. Low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity due to angina, chronic lower limb ischemia and heart failure symptoms. In this study, the investigators propose to use neuromuscular electrical stimulation (NMES) to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance.

Peripheral arterial disease is part of the diseases derived from arteriosclerosis are the leading cause of mortality in developed countries. There is evidence of the benefits of physical exercise programs supervised in patients with cardiovascular risk. Despite being a treatment with proven efficacy and relatively inexpensive, it continues being little used for the management of patients with intermittent claudication caused by peripheral arterial disease. The objective of this study is to develop an evidence-based intervention strategy on the effectiveness of supervised physical exercise in intermittent claudication to determine its impact compared to standard counselling in these patients.

Sympathetic overactivity partly promotes the development of peripheral artery disease which mainly leads to ischemia of the lower limbs. Endovascular arterial denervation (ED) is a minimally invasive technique which could deliver Radiofrequency energy by a multi-electrode catheter to the Lower limb artery to restore Sympathetic activity. The purpose of this study is to evaluate the effects of multi-electrode radiofrequency ablation system on lower limb ischemia with PAD.

Diabetic lower extremity arterial disease ( DLEAD ), is a common complication of type 2 diabetes. However, DLEAD remains less studied than other diabetic vascular complications; and only few randomised controlled trials (RCTs) have dealt with major lower-limb adverse events as prespecified endpoints. Studies have suggested that glucagon-like peptide-1 (GLP-1) analogues have a protective effect on the development of atherosclerosis, potentially mediated via the GLP-1 receptors expressed on endothelial cells, smooth muscle cells, and in monocytes/macrophages. The investigators aim to evaluate the improvement of lower extremity ischemia in patients with type 2 diabetes mellitus complicated with lower limb vascular lesions after liraglutide, compared with the standard-of-care treatment group.

This is a 15 patient clinical trial assessing the safety and feasibility of using Endometrial Regenerative Cells (ERC) in patients with critical limb ischemia (CLI) that are not eligible for surgical or catheter-based interventions. Three doses of ERC will be examined. The hypothesis is that ERC administration will be well-tolerated and possibly induce a therapeutic benefit.

The primary objective of this trial is to investigate whether intramuscular administration of allogeneic mesenchymal stromal cells (MSC) is safe and potentially effective, assessed as a composite outcome of mortality, limb status, clinical status (Rutherford classification) and pain score (visual analogue scale), in patients with no-option severe limb ischemia (SLI). The investigators will conduct a double-blind, placebo-controlled randomized clinical trial to investigate the effect of allogeneic bone marrow(BM)-derived MSC in patients with SLI, who are not eligible for conventional surgical or endovascular therapies. The investigators intend to include 60 patients, who will be randomized to undergo 30 intramuscular injections with either BM-MSC (30 injection sites with 5*10^6 MSCs each) or placebo in the lower leg of the ischemic extremity. Primary outcome i.e. therapy success, a composite outcome considering mortality, limb status, clinical status (Rutherford classification) and changes in pain score, will be assessed at six months.

The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperative complications, technical success, target lesion revascularization, amputation and clinical outcome.

The main aim of the present study was to evaluate the therapeutic potential and safety of transarterial infusion of granulocyte colony stimulating factor (G-CSF) mobilized cluster of differentiation (CD) 133(+) cells when combined with percutaneous transluminal angioplasty (PTA) in treatment of below the knee (BTK) peripheral arterial disease (PAD) in diabetic patients.

Peripheral arterial disease affects around 25% of the UK population aged over 55. Left untreated it can lead to debilitating pain, gangrene, amputation and death. It most commonly affects the lower limbs and in the earlier stages of the disease patients can present with a symptom known as intermittent claudication; pain felt in the legs which stops the patient from walking past a certain distance. Current National Institute for Healthcare and Excellence (NICE) guidelines recommend Supervised Exercise as first line treatment for patients with peripheral arterial disease presenting with intermittent claudication. Supervised exercise employs behaviour changing techniques which enable the patient to modify their lifestyles, improving their claudication symptoms, quality of life and reducing their cardiovascular risk. Despite this treatment being significantly more cost-effective than often employed complex endovascular management, most institutions don't offer such programmes citing lack of resources and compliance from clinicians and patients alike. The investigators propose a more cost-effective, resource-savvy solution in the form of REmotely SuPervised ExerCise Training (RESPECT). This allows the patient to exercise in the convenience of their own home, at a time of their choosing but still be supervised via fitness tracker technology and an online fitness platform. This randomised controlled trial will attempt to prove its' effectiveness in increasing claudication distance, improving functional ability, decreasing cardiovascular risk and improving quality of life whilst being more cost-effective than the currently recognised national first line treatment. This trial has the potential to revolutionise the management of patients with peripheral arterial disease.

Magnesium exerts analgesic effects in several animal pain models and in patients affected by acute postoperative pain and chronic pain of neuropathic origin. There is no evidence that magnesium can modulate pain in patients with peripheral arterial occlusive disease (PAOD). We describe the protocol of a single-center randomized double-blind clinical trial aimed at assessing the efficacy of oral magnesium supplementation in controlling severe pain in patients with advanced PAOD.