View clinical trials related to Peripheral Vascular Diseases.
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.
The FORWARD PAD IDE Study is a prospective, multi-center, single-arm investigational device exemption study, conducted to assess the safety and effectiveness of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.
The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to peripheral arterial disease. The main questions it aims to answer are: - Can intramuscular administration of Stempeucel® reduce symptoms of CLI due to peripheral arterial disease while improving the healing rate and functional outcomes? - Does intramuscular administration of Stempeucel® causes any serious adverse events in CLI due to peripheral arterial disease patients? Study patients will be assessed by the PI before administering the Stempeucel® for any other organ with inflammation. The study patients will also be followed up to the duration of 1 year after study treatment administration for safety and efficacy assessment.
Patients with PAD were grouped according to the combination of different anticoagulant and antiplate drugs. The type, dosage and duration of anticoagulant and antiplatelet drugs were recorded after operation. Major Adverse Cardiovascular Events and Major Adverse Limb Events were followed up at 1 month, 6 months and 12 months, respectively.
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.
This was a prospective, multicenter, randomized, controlled, non-inferiority clinical study with the primary objective of validating the safety and efficacy of the Suture-Mediated Closure System for percutaneous closure of the common femoral artery puncture site.
The primary purpose of this clinical trial is to test the feasibility of implementing a perioperative guided meditation program for patients undergoing peripheral vascular interventions that are performed under procedural sedation and analgesia.
Peripheral artery disease (PAD) is a chronic atherosclerotic process that causes narrowing of peripheral arterial vessels in the lower extremities. Osteopathic manual therapy (OMT) is one of the new treatment options for various pathologies. The aim of this study was to investigate the effect of OMT on arterial circulation in patients with PAD.
The goal of this study is to understand and compare an alternative model of care in comparison to the usual model of care in include male and female participants ≥18 years of age with a history of ASCVD (hear and blood vessels diseases) or high-risk participants who have elevated bad cholesterol (LDL-C ≥1.8 mmol/L). The alternative model of care includes telephone support calls from a study nurse (after visits 1,2 and 4) and text messages to your mobile phone with healthy heart information. The main question it aims to answer is to understand and compare an alternative model of care in comparison to the usual model of care by evaluating the study participants bad cholesterol values after 180 and 365 days of the study. Each participant will take their medications as per usual care but may have the addition of Inclisiran, 284 mg 1.5 ml liquid in a single-use prefilled syringe for under skin administration. In accordance with the current medical practice guidelines for treating heart related conditions, Inclisiran and its product information will be made available for use in both care models. All the participants who decide to take part in this study will be requested to do the following: - Answer any questions from the study doctor or the study staff as accurately as possible when asked about changes in health status, medications, heart health, visits to other doctors or hospital admissions, planned surgery, even if they think none of these are related to the study. - Study doctor will be able to inform them of which medications you can and cannot take as part of this study. - To use mobile phone to receive text messages and/or questionnaires as proposed in the new model of care. - Advise the study doctor if they plan to move away from the geographical area where the study is being conducted during the study period. - Take the medications for cholesterol lowering treatment (such as a statin and/or ezetimibe) that are prescribed by the study doctor. - Tell the study doctor or study staff as soon as possible about suspected participant / participant partner pregnancy. - Tell the study doctor or study staff if they change their mind about taking part in the study. - Attend all the visits (screening visit, visits 1, 2, 3, 4 and visit 5). - Provide all the information that will enable the study team to contact them, i.e., inform the study staff if contact details change, provide contact details of a family member, etc.
Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. However, there are still lack of data on procedural outcomes, in-hospital complications, and resource utilization on treatment of (complex) lesions in the femoral, popliteal and infrapopliteal artery in the real-world condition in Europe.