Clinical trials

Peripheral arterial disease (PAD) can progress to critical limb ischemia (CLI) of the affected lower limb, characterized by pain at rest, ulcerations or gangrene, with a high risk of amputation. In this phase, the best treatment is arterial limb revascularization, but this is not always possible or even effective for promoting pain relief, healing of ulcers or preventing amputations, in addition to the high socioeconomic cost caused by the disease. Recent advances in cell therapy represent a promising supporting alternative for the treatment of PAD in cases where conventional alternatives have run out. Objective: To evaluate the safety and efficacy of cell therapy with expanded autologous mesenchymal stem cells in the treatment of patients with PAD with CLI and chronic arterial ulcers. Methods: An open randomized clinical study will be performed with 2 groups of 20 patients with CLI: in group 1, a fragment of abdominal fat tissue (10g) will be collected to obtain mesenchymal stem cells, which will be expanded and applied using subcutaneous perilesional injection in the affected lower limb, in addition to the application in the form of a personalized curative biological on the wounds. Group 2 will receive conventional treatment with a Hydrogel dressing with essential fatty acids. Periodic clinical evaluations, complementary exams and photographic record will be carried out. The main outcome of effectiveness will be partial or total wound healing. Safety outcomes will be monitored for infections, gangrene, amputations and deaths. Participants will be monitored for 120 days. Major amputation cases will not be included. An independent external evaluator and blind to the groups will evaluate the results. It is an innovative procedure with high impact and financial return for SUS, in view of the high prevalence of the disease and the high socioeconomic impact of the disease when it progresses to limb amputation.

The goal of this prospective diagnostic accuracy cohort study is to compare the accuracy of carotid atherosclerotic plaques stiffness assessed by shear wave elastography (SWE) with greyscale median values (GSM), magnetic resonance imaging (MRI) and histopathological findings in patients with carotid atherosclerotic plaques causing stenosis above 50%, symptomatic or not. The main question it aims to answer is: is the plaque stiffness correlatable with GSM values, MRI findings or histopathological findings? Participants will be subjected to a vascular ultrasound study in which the SWE and GSM will be assessed. The second imaging modality for stenosis confirmation will be MRI and patients with confirmed symptomatic stenosis above 50% or assymptomatic stenosis above 70% will be considered for surgery intervention (endarterectomy or angioplasty). Patients that undergo endarterectomy will have the carotid plaques subjected to a histopathological study. The study will not arbitrate about the treatment decision.

The goal of this observational study is to evaluate the implementation of the INSPIRE program and to plan actions for the preparation, coordination, monitoring, diagnosis, and treatment of respiratory diseases in the municipality of Botucatu. Methods: Individuals with respiratory symptoms from the municipality of Botucatu, aged 18 or older, will be invited to participate in the study, and socioeconomic data, as well as information on sex, gender, race, nutritional risk, frailty, tobacco exposure, and its derivatives, will be collected. For those with exposure, screening and treatment for respiratory diseases will be offered through assessment of pulmonary function, body composition, respiratory and peripheral muscle strength. Additionally, individuals over 40 years old with tobacco exposure equal to or greater than 30 pack-years will be offered low-dose chest CT screening for lung cancer. Expected results: To identify and assess vulnerable groups that face difficulties in accessing respiratory healthcare, as well as implement specific strategies for the treatment of respiratory diseases and tobacco control for these groups. To ensure equitable access to respiratory health for the entire population at risk due to smoking. Moreover, through proactive and reactive risk reduction actions implemented by the program, to intervene in distinct groups and other regions.