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Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence — Pilot  

Varicose Veins Clinical Trial

Official title:
A Randomized, Single Blind, Placebo Controlled, Multicenter Study to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for the Treatment of Symptomatic, Visible Varicose Veins With Saphenofemoral Junction (SFJ) Incompetence.

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the treatment of varicose veins compared to placebo.

Clinical Trial Description

The purpose of this study is to evaluate the efficacy of polidocanol injectable foam vs placebo treatments in relief of symptoms using two disease specific questionnaires, establishment of a minimally important difference (MID) for the questionnaires, improvement in the appearance of visible varicosities by a patient and medical assessments aided by pre and post treatment photographs, and a central independent assessor evaluating pre and post treatment photographs. In addition, the study will evaluate the efficacy of polidocanol injectable foam vs the placebo treatment in the elimination of SFJ reflux or occlusion of the treated vein, and to determine whether the placebo procedure blinds the patient to treatment assignment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00758420
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase Phase 2/Phase 3
Start date October 2008
Completion date August 2009
View Details
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