Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins
Condition: Varicose Veins
MeSH terms: Varicose Veins
Study type: Interventional
Phase: Phase 4

Summary: 
      It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75%
      hypertonic glucose of sclerotherapy in lower limbs´ reticular veins. 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.
    

Detailed description: 
      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. Reticular veins are those with less than 3mm diameter,
      bluish and important contribution to the aesthetic damage, and sometimes they are related to
      local pain and recurrence after treatment of telangiectasias. 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 69 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 reticular veins. The
      patients will be examined and clinically classified. It will be included patients with
      reticular veins sited at out's thigh/leg, measuring at least 10cm long, 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 reticular veins of the lower
      limbs. The results may help physicians to choose the best sclerotherapy treatment for
      reticular veins.
    

Intervention name(s): Polidocanol with Glucose; Glucose
Intervention type(s): Drug; Drug
Intervention description(s): An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects; An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects
Other intervention name(s): Dodecylpolyethyleneglycolether; Aethoxysklerol; Varithena; Dextrose
Intervention MeSH terms: Polidocanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sclerotherapy; varicose veins; veins