CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 106 enrolled
Drug / intervention
Polidocanol with Glucose +1 moredrug
Likely dose
Polidocanol with Glucose 5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02054325
NCT02054325Phase 4Completed

A Randomized Triple-blind Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Sclerotherapy in Treatment of Reticular Veins at the Lower Limbs.

UPECLIN HC FM Botucatu Unesp·interventional·Posted Feb 4, 2014·Updated Jan 27, 2017

In Brief

A Phase 4 clinical trial evaluating Polidocanol with Glucose and Glucose for Varicose Veins. Completed, enrolled 106 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaricose Veins
CountriesBrazil

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 4, 2014
Enrollment StartSep 1, 2012
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.4 years ago

Interventions

Polidocanol with Glucosedrug

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

Glucosedrug

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