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Double-blind, controlled and long-term follow-up prospective study for patients submitted to sclerotherapy treatment in reticular vein and telangiectasias in lower limbs with polidocanol 0.2% diluted in glucose 70% VESUS 75% pure glucose

Grant number: 16/15004-0
Support type:Scholarships in Brazil - Scientific Initiation
Effective date (Start): October 01, 2016
Effective date (End): September 30, 2017
Field of knowledge:Health Sciences - Medicine - Surgery
Principal Investigator:Matheus Bertanha
Grantee:Caio Paiva Pellizzer
Home Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil

Abstract

The prevalence of chronic venous disease is high and occurs more often in women. According to definition of clinical, etiologic, anatomic and pathophysiologic (CEAP) classification, reticular veins and telangiectasias are includedin the C1 class and are mainly associated with aesthetic complaints. Several techniqueshave been used for treatment, including microphlebectomy, laser ablation andradiofrequency ablation. Several sclerosing agents can be used as a less invasivealternative, but there is no consensus about the maintenance of the clinical outcome inlong term and the occurrence of any patches of hyperpigmentation. Methods: Thisproject intends to convene 192 patients undergoing sclerotherapy treatment of reticularveins and telangiectasia in the study called "randomized and double-blind clinical trialcomparing two sclerotherapy methods for tratment of reticular veins and telangiectasiasof the lower limbs" Patients will be informed about the study, then invited to sign againa new consente. After that, will be collected epidemiological and clinical data regardingthe follow-up, in addition to performing the photographic record of the previouslytreated area (lateral thigh and leg). These new photos (3 year follow-up) will becompared to pre-treatment and 60 days post treatment. Objectively, the followingparameters will be analyzed: reappearance of the treated veins and any patches ofhyperpigmentation (this will be done by 2 blinded independent evaluators). Statisticalanalyzes will be carried out in order to prove the long-term results.