The Effect of Cooling on Sclerotherapy Efficacy

Exclusion Criteria

• •A subject requires greater than 10 mL total of glycerin, including a maximum of 6 mL of polidocanol for foam sclerotherapy, for either lower extremity during a single leg treatment.
• •Asymmetric amount, distribution, and/or severity of reticular veins and/or telangiectasias between lower extremities
• •The subject has a CEAP Class of C2 or greater, as evidenced by clinically apparent varicosities, venous stasis, stasis dermatitis, lipodermatosclerosis, and/or venous ulceration (or history of lower leg ulcerations).
• •The subject has history of or current great saphenous vein (GSV), saphenofemoral junction (SFJ), or saphenopopliteal junction (SPJ) incompetency based on prior Doppler and/or duplex evaluation or has physical exam findings suspicious for it.
• •The subject has a history of deep vein thrombosis, thrombophlebitis, thromboembolic disease, and/or underlying hypercoagulable medical condition (e.g. hemophilia, Factor V deficiency).
• •The subject has a history of uncontrolled or severe asthma, or asthma requiring hospitalization or intubation.
• •The subject has a history of allergic reactions to sclerosing agent.
• •The subject has a history of allergic reaction or sensitivity to lidocaine or epinephrine.
• •Any of the following medications, procedures or treatments to the purposed treatment area/s
• •1. Within 6 months prior to screening visit (i.) The subject has undergone sclerotherapy
• •2. Within 3 months prior to screening visit (I.) NO OTHER COSMETIC OR SURGICAL TREATMENTS TO THE PURPOSED TREATMENT AREA/S
• •The subject is non-ambulatory or poorly ambulatory.
• •The subject has a history of neurological conditions.
• •The subject is pregnant, lactating, or in child bearing age (and sexually active) and not using an approved contraceptive measure.
• •The subject is taking disulfiram, tamoxifen, or oral hormone therapy (not including hormonal birth control).
• •The subject has a history of noncompliance with clinical protocols.
• •The subject has participated in any other clinical trial that involves an investigational medication or device within the last 30 days.
• •Planning to have any treatments or procedures to bilateral lower extremities for the duration of the trial.