NCT00758420

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

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.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Varicose Veins

Interventions

Type	Name	Description
DRUG	Varisolve (Polidocanol Endovenous Microfoam)	1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2)
DRUG	Agitated Saline	10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-07-01
• Completion: 2009-08-01
• First posted: 2008-09-25
• Last updated: 2021-04-21
• Results posted: 2014-03-24

Locations

5 sites across 1 country: United States