Vascular Diseases, Venous Insufficiency, Varicose Veins
Conditions
Interventions
This is a randomized, open-label, single-center, three-arm clinical study. A total of 120 participants who meet the eligibility criteria will be randomized into one of the groups, with a total of 40 i
Sponsors
Hospital Universitário Pedro Ernesto
Hospital Universitário Pedro Ernesto
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age greater than 18 years; patients of both sexes; presenting chronic venous disease with clinical classification C2, C3, C4, C5, or C6 according to Clinical-Etiology-Anatomy-Pathophysiology; presenting proximal, multi-segmental, or diffuse great saphenous vein insufficiency with a diameter greater than 6mm in a segment longer than 20 cm in length; signing the informed consent form
Exclusion criteria
Exclusion criteria: Patients will be excluded in the event that the Doppler ultrasound reveals acute deep vein thrombosis, chronic deep vein thrombosis without recanalization, varicose disease not associated with great saphenous vein insufficiency; patients who have previously undergone varicose vein surgery; patients with thrombophilias; active neoplasia or cancer under treatment; pulmonary diseases or peripheral arterial disease with an ankle-brachial index less than 0.6
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occlusion of the great saphenous vein, assessed by the absence of compressibility during Doppler ultrasound, as a result of the dense foam treatment with polidocanol after a six-month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Failure of treatment defined by patency of the great saphenous vein, assessed by the presence of luminal flow during Doppler ultrasound, after five sessions of treatment with dense foam polidocanol | — |
Countries
Brazil
Contacts
Public ContactDouglas Figueiredo
Hospital Universitário Pedro Ernesto
Outcome results
None listed