Study Brochure
 
Varicose Veins can hurt more than your self-image
Varisolve® is being studied as an investigational new non-surgical treatment for varicose veins.
 
Varicose Vein Facts...
  • Varicose veins affect approximately 20% of the adult population (that is roughly 40 million people in the US).
  • Varicose veins tend to develop between the ages of 30 and 60.
  • Women are 4 times more likely to develop varicose veins than men.
  • Women are most likely to develop varicose veins after a pregnancy.
  • Varicose veins can be associated with swelling of the feet and ankles, tiredness, heaviness, and the development of leg ulcers.
  • Less than 1% of people with varicose veins actually undergo corrective treatment.
  • If left untreated, varicose veins can lead to serious health problems.
Varicose Vein Research...
Varicose veins are not just a cosmetic problem. In addition to causing symptoms such as pain and swelling, varicose veins can lead to serious health consequences. Left untreated, varicose veins can continue to get worse.

Varisolve® microfoam is a non-surgical investigational treatment under development for the treatment of varicose veins. It is a sclerosant. A sclerosant is a chemical which causes veins to close. This sclerosant has been made into a foam of very small bubbles to create a microfoam.

The purpose of the Varisolve® Study is to evaluate the effectiveness and safety of the Varisolve® microfoam compared to an alternative treatment. The effectiveness of the study treatments will be measured using questionnaires, photography and an ultrasound of the leg with varicose veins before and after study treatment.

The study will also test how safe and how well tolerated Varisolve® is when injected into veins, and it will look at the possible side effects of the Varisolve® treatment. The study is being conducted at approximately 5 to 7 study sites in the US. Approximately 100+ men and women with varicose veins will participate in the study. You may qualify for the Varisolve® Study if you are male or female and:
  • are between the ages 18 and 65.
  • have varicose veins that are enlarged, swollen, or bulging and rise above the surface of the skin, and that cause symptoms.
Other requirements must be met to participate in the study.
 
About Clinical Research...
A clinical research study evaluates whether an investigational medication is safe and effective in treating a particular disease and checks for any unwanted side effects. All new investigational medications must be tested in this way.

Clinical research studies are performed according to strict governmental guidelines. These guidelines ensure that subjects’ rights are protected in the study, while still allowing valuable information about the new investigational medication to be collected. A new investigational medication must pass 3 phases of clinical testing before it can be evaluated by the FDA for possible approval. Varisolve® has completed Phase II testing. This means the investigational medication:
  • Has been tested for safety and effectiveness in a small group of people with varicose veins (640 patients in Europe and the USA).
  • Has not been approved for use by the Food and Drug Administration (FDA).
During this study, doctors will further evaluate the effectiveness of the study medication. They will also continue to look at its safety and side effects over a longer period of time, with a much larger group of subjects.
 
What to Expect...
This study will involve up to 9 clinic visits over the course of about 6 months.
 
Find out More…
Varicose veins are a real medical condition and not just a cosmetic problem. Left untreated, varicose veins can lead to serious health problems, such as leg ulcers. Get on your feet today and seek information about varicose veins and a research study. If you or someone you know has varicose veins and would like to learn more about the Varisolve® Study, please complete the online pre-qualification survey to determine if you pre-qualify.