View clinical trials related to Peripheral Arterial Disease.
Filter by: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.
A significant challenge in medical care is atherosclerotic occlusion of peripheral arteries, such as lower extremities and brachiocephalic arteries, which can eventually lead to loss of limbs or fatal ischemic strokes. Revascularizing surgical interventions can restore the lumen of the arteries and provide an effective way to treat such patients. However, up to a third of patients need re-intervention or experience cardiovascular complications within a year after surgery. The purpose of this study is to evaluate the effect of adding the natural dietary supplement Allicor to conventional treatment on the incidence of cardiovascular complications and treatment effectiveness 12 months after revascularization. Another valuable area of investigation is the search for predictors of long-term cardiovascular complications after revascularization, which could be markers of inflammation and heteroplasmy levels in the patient's mitochondrial genome.
This study aims to evaluate the safety and performance of the QBX stent system in the treatment of PAD by reporting of peri- and postoperative complications, including major adverse vascular events (MAVE), Vascular Access Site Complications (VASCs) and bleeding at puncture site, and by evaluating the prevalence of Target Vessel Revascularization (TVR), amputations, procedural success, device performance, reduction in percentage diameter stenosis post-procedure compared to pre-procedure, artery patency, return to normal activity, Rutherford and Fontaine classification, quality of life (QoL), Ankle Brachial Index (ABI), and hospital- and patient-related costs in a prospectively maintained database.
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.
Microbiota has been associated with risk factors for cardiovascular diseases (hypertension, obesity, dyslipidemia, diabetes mellitus, heart failure). In animal models, the gut microbiota produces pro-inflammatory proteoglycans that increase the extent of myocardial infarction, reduced by treatment with probiotics (Lactobacillus). TMAO, a blood metabolite directly dependent on the gut microbiota is related to atherosclerotic plaque instability and major adverse cardiovascular events (MACE) in humans. Recent data demonstrate that blood levels of TMAO directly correlate with the risk of major MACE and mortality in patients with peripheral arterial disease (PAD). The goal of this observational study is to evaluate the association between gut microbiota and TMAO serum levels and MACE and major adverse limb events (MALE) in patients with PAD and chronic limb threatening ischemia (CLTI) requiring a procedure of endovascular revascularization. The main questions it aims to answer are: - association between gut microbiota and TMAO serum levels and MALE after lower extremity revascularization. - association between gut microbiota and TMAO serum levels and MACE after lower extremity revascularization. Patients with CLTI requiring lower extremity endovascular revascularization will undergo stool sampling for determination of gut microbiota and blood sampling for the dosage of circulating TMAO before the endovascular procedure. Incidence of MALE and MACE will be collected in a 24-months follow-up and will be associated with gut microbiota and TMAO serum levels.
This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (PAD).
The purpose of this post-authorization registry is to describe the clinical outcomes of de novo and restenotic lesions in the superficial femoral and/or popliteal artery treated with the PULSAR® -18 T3 stent, implanted both primary and salvage.
A prospective randomized trial to validate the efficacy and safety of rapamycin coated peripheral balloon catheter in the treatment of femoral popliteal artery disease.
The purpose of this study is to evaluate whether adding sulodexide to the patients with varicose veins who received radiofrequency ablation combined with sclerotherapy can reduce or improve the impact of adverse events。
Prevalence of diabetes mellitus (DM) is increasing rapidly, with patient numbers projected to rise to 643 million by 2030. As a consequence of diabetes-related atherosclerosis, peripheral arterial disease (PAD) and in particular medial arterial calcification (MAC) can occur. The accurate identification of PAD by bedside tests is extremely important in patients with diabetes and foot ulceration, in order to reduce delayed wound healing, prevent lower limb amputation and eventually reduce mortality. However, as shown in previous systematic reviews, the performance of current bedside tests is not reliable in excluding PAD in diabetic patients.1,2 Moreover, the methodological quality of the conducted studies is generally poor. Therefore, more reliable and prospective data is required. Also alternative bedside tests need to be investigated. As an example, the ACCmax (a new doppler derived parameter) could be particularly promising in this patient group.