Varicose Veins Clinical Trial
Official title:
Polidocanol Versus Glucose For Sclerotherapy Treatment Of Telangiectasia Of The Lower Limbs: Protocol For A Randomized, Controlled Clinical Trial
It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75% hypertonic glucose of sclerotherapy in lower limbs´ telangiectasis. It will be included only adult women with reticular veins on the side of the thighs and mild venous insufficiency (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.
Background. The prevalence of chronic venous disease is high in the general population,
mainly in young women, and in milder cases the usual complaint is aesthetic. Various
techniques are used for treatment of mild varicose disease, including surgical treatment,
laser ablation and sclerotherapy. Telangiectasis are those with less than 1 mm diameter,
reddish and important contribution to the aesthetic damage, and sometimes they are related to
local pain. There is no consensus in the literature about the effectiveness of treatment with
sclerotherapy, despite of being an usual procedure with different chemicals.
Methods and design. One hundred lower limbs of healthy women between 18 and 65 years will be
triple blind randomized to receive treatment with polidocanol 0.2% diluted in 70% hypertonic
glucose versus 75% hypertonic glucose for sclerotherapy treatment of telangiectasis. The
patients will be examined and clinically classified. It will be included patients with
telangiectasis sited at out's thigh, and only one extremity will be included per patient. The
patients with varicose disease CEAP 2 or more will not be included. The treatment will be
carried out in only one session and the medication volume not exceeding 5 ml. Clinical
follow-up protocols will be filled on regular visits on days 0 - 7 - 60 concomitantly with
photograph documentation. Supplementary examination for venous mapping with ultrasound
pretreatment is performed for all patients.
Discussion. This prospective controlled double-blind randomized trial aims to verify and
compare the efficacy and safety for sclerotherapy treatment of telangiectasis of the lower
limbs. The results may help physicians to choose the best sclerotherapy treatment for
telangiectasis.
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