Clinical study of the use of electrical stimulation on leg circulation and coagulatio

Phase 2

• Conditions: Venous Thrombosis; Peripheral Arterial Disease; Venous Insufficiency; C14.907

• Registration Number: RBR-6gs4bdh
• Lead Sponsor: Departamento de Cirurgia e Ortopedia da Faculdade de Medicina de Botucatu

Brief Summary

The prevalence of peripheral vascular diseases is on the rise, mainly due to the increase in their risk factors, such as the aging of the population, the three with greatest clinical significance being peripheral atherosclerotic obstructive disease (PAOD), chronic venous insufficiency (CVI) and venous thromboembolism (VTE). Muscle physical exercise stimulates circulatory development. But it is not always possible. A clinical, interventional, prospective, single-center, randomized, single-blind study was carried out to evaluate the effect of neuromuscular electrical stimulation in 10 healthy individuals, in which there was an increase in the velocity of arterial and venous blood flow in the lower limbs, an increase in the volume of venous flow in the popliteal vein, increased diameter of femoral and popliteal vessels in healthy individuals and non-significant increase in tissue plasminogen activator. The systemic effects of neuromuscular eletric stimulation (NMES) have also been demonstrated, in the absence of adverse events and significant discomfort.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-03-03
• Study Start: 2024-01-29
• Last Update Posted: 5 March 2024

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Being between 18 and 40 years old. Both genders. Sign the Free and Informed Consent Form. Have a Body Mass Index (BMI) between 18 and 34 kg/m2

Exclusion Criteria

Use of illicit drugs in the last 12 months. Use of the following medications in the last 24 hours: medicines for headache with vascular effect, such as sumatriptan, ergot derivatives, isomeptene, etc, analgesics such as dipyrone and paracetamol, non-steroidal anti-inflammatory drugs such as ibuprofen, naproxen, diclofenac, etc. Consumption of foods in the last 24 hours with a known effect on vascular reactivity, according to the list: coffee, folic acid, vitamin C, high doses of fish oil, vitamin supplements, fruits and vegetables in large quantities such as cranberries (also known as cranberries) and grapefruit (also known as grapefruit), beets and black currants, wine, tea, cocoa and derivatives, chocolate and hazelnuts, natural grape and orange juice, cheese, probiotics (foods with this effect), capsaicin, like pepper, energy drinks, beer. Any significant illness within the last 4 weeks of exposure. Pregnancy or lactation. Use of hormonal contraceptive method, including IUD etc., in the last 3 months. Active smoker or ex-smoker in the last 12 months. History of peripheral arterial obstructive disease. Ankle-brachial index less than 0.9, defined in anamnesis and physical examination. History of chronic venous insufficiency in the lower limbs. Ulcer on lower limbs. History of venous thromboembolism. History of fracture or presence of metallic implants in lower limbs. Have an infection at the electrode implantation site. Have participated in a drug or medical device study up to 4 weeks previously. Use of any neuro-modulating device. Surgery 3 months before the study (such as abdominal, gynecological, etc.). Trauma to the lower limbs that may prevent correct electrical stimulation of the common peroneal nerve. Use of a pacemaker or implantable cardioverter-defibrillator

Study & Design

• Study Type: Intervention
• Study Design: Not specified