View clinical trials related to Vascular Disease, Peripheral.
Filter by:Background: Peripheral arterial disease (PAD) is the main cause of amputation to the lower limb within the UK, affecting over 20% of adults older than 70 years. After an amputation, individuals often use a wheelchair and do not walk with a prosthetic limb. This is due to them experiencing: older age, muscle weakness, pain, other health conditions limiting ability to exercise eg. heart problems. Healthcare professionals assess physical function with Physical Performance Based Outcome Measures (PerBOMs). A PerBOM requires an individual to complete tasks that are part of their day to day life e.g. walking or balance. PerBOMs are used with for: - Setting goals with patients - Assessing how patients respond to treatment/rehabilitation - Predicting if patients are likely to use a prosthetic limb in the future Previous research shows most of the available PerBOMs are suitable an amputee who walks with a prosthetic limb. However, most vascular amputee patients cannot benefit from these assessments. Therefore, based on this evidence we have developed a new PerBOM to help manage vascular amputees who do not walk with a prosthetic limb. Methods: Qualitative interviews and focus groups with amputee individuals and healthcare professionals who treat them. Approaching individuals who have or will undergo an amputation to their leg due to PAD. Approaching healthcare professionals through professional networks. Interviews and focus groups will take place face to face or remotely by telephone/video conferencing, lasting approximately 1-2 hrs. In the interview or focus group, the researcher will explain and show individuals a video of the new PerBOM and explore their opinions qualitatively on this new PerBOM. All audio will be recorded, written up and analysed. All findings will be presented at scientific conferences. This study has been developed with patients and public involvement.
Diabetes is a serious and chronic disease that affects more than 347 million people in the world. It is the leading cause of death by age and its prevalence is increasing annually throughout the world. Diabetes is a disorder that manifests itself with elevated blood glucose levels that may be the resultof a deficiency in insulin secretion or action, or a combination of both problems. The "Diabetic foot" includes a number of syndromes in which the interaction of the loss of protective sensation by the presence of sensory neuropathy, the change in pressure points due to motor neuropathy, autonomic dysfunction and decreased Blood flow due to peripheral vascular disease can lead to the appearance of injuries or ulcers induced by minor traumas that go "unnoticed." This situation leads to significant morbidity and a high risk of amputation. It can be prevented with the application of prevention programs, based on the early detection of neuropathy, assessment of associated risk factors, along with the application of a structured program of education and treatment of risk factors. PRIMARY OBJECTIVES: 1- Comparison of ulceration rates, decrease in amputation rates in the target population with intervention: LSCI, thermography and creation of personalized insoles versus the control group with assessment, treatment and follow-up, without the intervention of interest in the study. 2- Correlation between changes in perfusion and temperature detected in combination of LSCI and thermography to predict diabetic foot ulcers and the risk of having ulcers. Study Model: Parallel Assignment 1:1 . Patients with inclusion criteria and without exclusion criteria will be randomized into two groups with Randomization with sequence concealment, centralized in computer support. OxMaR (Oxford Minimization and Randomization) After signing the informed consent, the patients will be divided into two groups. Number of Arms 2 Masking: None (Open Label) A-GROUP WITH LSCI, 3D FOOT CREATOR FOLLOW UP B- GROUP WITHOUT LSCI, 3D FOOT CREATOR FOLLOW UP.
The European Working Group on Sarcopenia in the Elderly1 defines sarcopenia as a disorder of the progressive and generalized musculoskeletal system [1], which is associated with the increase and probability of adverse outcomes including falls, fractures, physical disability, and mortality [2]. what is associated with increased and likelihood of adverse outcomes including falls, fractures, disability physical and mortality [2]. For a long time, sarcopenia was associated with aging, affecting onlyold people. At present and after several research works related to fragility and theaging, it has been identified that the development of sarcopenia begins earlier in life [3], and that there are many contributing causes besides aging [4], [5]. This new knowledge has implications in the intervention of sarcopenia that prevents or delays its development. Sarcopenia is currently considered a muscle disease (muscle failure), based on adverse changes in the muscles of the musculoskeletal system accumulated throughout life, with loss of muscle strength such as main determinant [6], [7]. Sarcopenia has been overlooked in clinical practice, apparently due to to the complexity in determining the variables to be measured, how to measure them, and the values or cut-off points can guide diagnosis and treatment, and how best to assess the effects of therapeutic intervention [8]. In terms economic, the presence of sarcopenia increases the risk of hospitalization and increases the cost of care during hospital admission [9]. Diabetes is the main cause of non-traumatic amputation of the lower limb (MI), being foot ulcers diabetic the cause of 80% of the amputations of people with diabetes[10]. A study conducted by the Chongqing University Hospital showed that sarcopenia is independently related to the foot diabetic and that patients with diabetic foot have a worse prognosis if they suffer from sarcopenia. HYPOTHESIS: The surface electromyography (EMGs) signal recording of the foot musculature, will allow extracting biomarkers that allow monitoring and follow-up of sarcopenia in diabetic patients. MAIN OBJECTIVES: 1- Generate tools based on artificial intelligence (AI) using the database with the biomarkers obtained, in order to analyze the predisposing and triggering risk factors associated with diabetic foot ulcers, according to the IWGDF2. 2- Describe the profile of the diabetic patient in terms of degree of sarcopenia with respect to the population without diabetes in a group of adults. DESIGN: Observational study comparison between cases and controls: a group with the presence of Diabetes Mellitus and another without. SAMPLE: Approximately 16% of diabetic patients will develop an ulcer during their evolution and the Annual incidence is 2-3%, which doubles to 6% in the presence of polyneuropathy. Population of the Department of Health 168,978. Prevalence of diabetes in Spain 7.8%. It is estimated that there are 13,182 in the department people with diabetes. Confidence level 95%, expected frequency of ulcers 6% and confidence limit 9%, it was calculates the sample of 26 patients. 30 patients per group will be recruited. GROUP 1: 30 patients with Diabetes Mellitus. GROUP 2: 30 control patients without Diabetes Mellitus. The period of inclusion of patients is estimated at 5 months. METHOD: the assessment interventions will be carried out in two days. During the first visit, examination to identify risk to the foot: clinical history (PA, comorbidity data, previous injuries to the feet). feet..), examination of the vascular state, examination of loss of protective sensitivity, perception of pressure, skin inspection, inspection of bone/joint structures, physical limitations and level of knowledge of the foot care. During the second visit: diagnostic tests for sarcopenia (bioimpedance and electromyography), arthropometric measurements, malnutrition, dependence and activity marker tests. EXPECTED RESULTS: clarify some aspects related to the sarcopenia-diabetic foot binomial, and isolate risk factors for future prevention, by obtaining biomarkers with EMGs in lower limbs.
Cardiovascular disease (CVD) represents the leading cause of death worldwide. While medications, such as statins, significantly reduce atherosclerotic CVD (ASCVD) risk by lowering low density lipoprotein levels, they may also have pleiotropic effects on inflammation. The immunomodulatory effects of these medications are relevant to ASCVD risk reduction given that inflammation plays a central role in atherosclerotic plaque formation (atherogenesis) and influences the development of vulnerable plaque morphology. Patients on statins, however, may have residual inflammation contributing to incident ASCVD despite the potent LDL-lowering effects of statins. While new therapies, such as proprotein convertase subtilisin/kexin type 9 (PSCK9) inhibitors, further reduce incident ASCVD and drastically reduce LDL-C below that achieved by statin therapy alone, PCSK9 inhibitors may also have pleiotropic effects on inflammation. Thus, PCSK9 inhibitors may help reduce arterial inflammation to a level closer to that of patients without ASCVD. This study will apply a novel targeted molecular imaging approach, technetium 99m (99mTc)-tilmanocept SPECT/CT, to determine if residual macrophage-specific arterial inflammation is present with statin therapy and the immunomodulatory effects of PSCK9 inhibition. Given the continued high mortality and morbidity attributable to ASCVD, strong imperatives exist to better understand the immunomodulatory effects of lipid lowering therapies and residual inflammatory risk. This understanding, in turn, will inform the development of new ASCVD preventative and treatment strategies as well as elucidate other indications for established therapies.
Background: Although exercise training is a well described therapy for some cardiometabolic diseases such as obesity, type 2 diabetes, arterial hypertension, and metabolic syndrome, there is scarcity of knowledge about the post-exercise period term as 'detraining' where usually all physiological adaptations as cardiovascular and metabolic benefits are lost due to physical inactivity. Likewise, as some exercise training modalities as high-intensity interval training improve vascular parameters including endothelial dysfunction parameters as flow-mediated dilation (FMD%), and carotid-intima media thickness (c-IMT) during the 'training' period, there is little knowledge about how many 'volume' or 'intensity' of exercise training or physical activity per week is needed to maintain the exercise training benefits in populations with cardiometabolic risk factors such as those patients with arterial hypertension. This information will be of great interest for both improving and maintaining the vascular profile and health of Chilean adults with risk factors and to maintain a better vascular profile. Objective: To study the beneficial adaptations from the 'training' and 'detraining' period of exercise training on functional and structural vascular parameters in healthy and cardiometabolic risk factors adult subjects to improve the health profile. Methods: The investigators will conduct an experimental design of 5 groups of exercise training in healthy (controls) and hypertensive (HTN) patients (≥140 mmHg), with overweight/or obesity, men and women, with BMI ≥25 and ≤35 kg/m2, aged ≥18y, physically inactive (<150 min/week of low/moderate PA/week, or <75 min/week of vigorous PA) in the last 6 months will be invited for participating. The groups will be as follows; Group (HTNex will be compared with Group HTNcg). Group (ELEex will be compared with Group ELEcg). Group (NTex will be compared with Group NTcg). Each group will be compared in their physiological vascular adaptations before and after exercise training such as HIIT, and after 3 months of a detraining period. Results (hypothesis): The investigators hypothesized that the maintenance of vascular outcomes after the 'detraining' period is intensity-dependent in adults with HTN that participated of an exercise intervention.
Prospective, multi-center, single-arm study of the M5+ Peripheral IVL system to treat calcified peripheral arteries.
Heparin-Binding protein is a protein from primary and secretory granluae of white blood cells. It is released when white blood cells become activated and has been advocated as a biomarker for sepsis. The aim of this study is to find out if Heparins in clinical doses can change the level of Heparin-binding protein in plasma.
This is a multi-center, randomized, blinded, placebo controlled study to evaluate the safety of GSK1278863 and its acute and short-term (e.g. 14d) effects on calf muscle endurance and walking ability in subjects with PAD and symptomatic claudication.
The occurrence of Peripheral Vascular Disease has been increasing which includes the large artery in the upper leg called Superficial Femoral Artery (SFA). The Peritoneal Lined Stent has been developed as a new method for treating narrowed area in the SFA. This research study will determine the safety and effectiveness of the Peritoneal Lined Stent in keeping th Superficial Femoral Artery open and allowing blood to flow in the leg.
The purpose of this study is to investigate the prevention of Restenosis following Revascularization of the superficial Femoral Artery (SFA)