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

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