Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers

Inclusion Criteria: * Must have given written informed consent and HIPAA authorization * Must be ≥ 18 years of age * Must have a venous ulcer for 60 days or greater * ABPI \> 0.8 and ≤ 1.2 * Must have ulcer between 3cm2 and 25cm2 in size Exclusion Criteria: * Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency * BMI ≥ 35 * Has evidence of clinical infection * Suffers from diabetes mellitus with HbA1c ≥ 8% * Suffers from clinically significant arterial disease * Has a known allergy to any of the compounds / drugs that are part of this protocol * Has evidence of the ulcer and / or infection extending to the underlying muscle, tendon or bone * Has used any investigational drug(s) within 30 days preceding randomization * Is unable to manage self-treatment * Is pregnant, nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinence) * Suffers from a condition which in the opinion of the Investigator would compromise the safety of the subject and / or the quality of the data * Is using any of the prohibited concomitant medications or treatments * Has previously participated in this study