Phase 3 N=279 Randomized Double-blind Treatment

Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

Varicose Veins

Bottom Line

View on ClinicalTrials.gov: NCT01072877 ↗

Enrolled (actual)

279

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) — 2.13; 4.63; 5.68; 4.87 units on a scale — p==0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Polidocanol injectable foam (PEM) (Drug); Placebo Vehicle (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boston Scientific Corporation
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)	2.13; 4.63; 5.68; 4.87; 5.78	=0.0001 sig
SECONDARY Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)	-0.15; -0.93; -1.40; -1.60; -1.75	=0.0001 sig
SECONDARY Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance	-0.01; -0.46; -0.77; -0.76; -0.91	=0.0001 sig

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 injectable foam compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

Eligibility Criteria

Inclusion Criteria

Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
Ability to comprehend and sign an informed consent document and complete study questionnaires in English
Ability to record symptoms in accordance with the protocol
Symptomatic varicose veins
Visible varicose veins

Exclusion Criteria

Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP (clinical, etiologic, anatomic, and pathophysiologic) Classification of Venous Disorders).
Leg obesity impairing the ability to access the vein to be treated and/or to apply postprocedure compression bandaging and stockings
Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion
Deep vein reflux unless clinically insignificant in comparison to superficial reflux
Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
Reduced mobility
Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)
Known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions
Current alcohol or drug abuse
Pregnant or lactating women
Women of childbearing potential not using effective contraception
History of DVT, pulmonary embolism or stroke

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01072877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.