Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

Summary

Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

Timeline

Start

2010-11

Primary completion

2011-09

Completion

2014-08

Outcome

Met primary endpoint

registry Vehicle vs Polidocanol Injectable Foam, 0.125%; p <0.0001; Mean Difference (Final Values) -3.34 (95% CI -4.63 to -2.04); ANCOVA NCT01231373 ↗

registry Vehicle vs Polidocanol Injectable Foam, 0.5%; p <0.0001; Mean Difference (Final Values) -4.00 (95% CI -5.26 to -2.74); ANCOVA NCT01231373 ↗

registry Vehicle vs Polidocanol Injectable Foam, 1.0%; p <0.0001; Mean Difference (Final Values) -3.05 (95% CI -4.33 to -1.77); ANCOVA NCT01231373 ↗

Publications

• Todd KL 3rd, Wright DI; VANISH-2 Investigator Group. Durability of treatment effect with polidocanol endovenous microfoam on varicose vein symptoms and appearance (VANISH-2). J Vasc Surg Venous Lymphat Disord. 2015 Jul;3(3):258-264.e1. doi: 10.1016/j.jvsv.2015.03.003. Epub 2015 May 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Polidocanol	Other / unclassified	0.125 %	Other
Subject	Polidocanol	Other / unclassified	0.5 %	Other
Subject	Polidocanol	Other / unclassified	1 %	Other

Indications