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

Inclusion Criteria: * Must have a venous stasis ulcer between the knee and the ankle. * Ulcer duration must be 60 days or greater Exclusion Criteria: * Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency * Suffers from diabetes mellitus with HbA1c ≥ 8% * Suffers from clinically significant arterial disease * Is pregnant, a nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinent) The above is a partial list of the inclusion and exclusion criteria; however, other inclusion and exclusion criteria may apply.