COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (VANISH-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01231373
Recruitment Status : Completed
First Posted : November 1, 2010
Results First Posted : April 2, 2014
Last Update Posted : March 12, 2015
Information provided by (Responsible Party):
BTG International Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Varicose Veins Drug: polidocanol injectable foam, 0.125% Drug: polidocanol injectable foam, 0.5% Drug: polidocanol injectable foam, 1.0% Drug: Vehicle Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Varisolve Polidocanol Endovenous Microfoam (PEM) 0.5% and 1% Compared to Vehicle for the Treatment on Saphenofemoral Junction (SFJ) Incompetence "VANISH-2"
Study Start Date : November 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins
Drug Information available for: Polidocanol

Arm Intervention/treatment
Experimental: polidocanol injectable foam, 0.125% Drug: polidocanol injectable foam, 0.125%
active placebo for blinding

Experimental: polidocanol injectable foam, 0.5% Drug: polidocanol injectable foam, 0.5%
0.5% polidocanol foam injection

Experimental: polidocanol injectable foam, 1.0% Drug: polidocanol injectable foam, 1.0%
1.0% polidocanol foam injection

Placebo Comparator: Vehicle Drug: Vehicle
injection of vehicle comparator

Primary Outcome Measures :
  1. Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score) [ Time Frame: 8 weeks ]
    The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINES QOL/Sym items that have been determined in earlier studies to be most important to patients. The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25). At Visit 2/baseline, Week 8, scores were calculated.

Secondary Outcome Measures :
  1. Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) [ Time Frame: 8 weeks ]
    The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram fo the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from "Not at all noticeable" (a score of 0) to "Extremely noticeable" (a score of 4).

  2. Change From Baseline at 8 Weeks Post-Treatment in IPR-V3 Score--Physician Photographic Review of Appearance [ Time Frame: 8 weeks ]
    The Independent Photography Review--Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 3 trained, blinded clinicians, evaluated the appearance of the patient's visible varicose veins using the IPR-V3 instrument's 5-point scale (0-4, where 0=none and 4=very severe visible varicose veins).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 Classification of Venous Disorders).
  • Leg obesity impairing the ability to access the vein to be treated and/or to apply post-procedure 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01231373

Layout table for location information
United States, Alabama
Dothan, Alabama, United States, 36303
United States, California
San Diego, California, United States, 92120
San Diego, California, United States, 92121
United States, Indiana
Lafayette, Indiana, United States, 47905
United States, Maryland
Frederick, Maryland, United States, 21701
Hunt Valley, Maryland, United States, 21030
United States, New Mexico
Los Alamos, New Mexico, United States, 87544
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Monroeville, Pennsylvania, United States, 15143
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Greenville, South Carolina, United States, 29615
United States, Washington
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
BTG International Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: BTG International Inc. Identifier: NCT01231373    
Other Study ID Numbers: VAP.VV016
First Posted: November 1, 2010    Key Record Dates
Results First Posted: April 2, 2014
Last Update Posted: March 12, 2015
Last Verified: February 2015
Keywords provided by BTG International Inc.:
varicose veins
Additional relevant MeSH terms:
Layout table for MeSH terms
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Sclerosing Solutions
Pharmaceutical Solutions