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

An Investigation of the Topical Application of Gaseous Nitric Oxide on Safety and Efficacy in Venous Stasis Leg Ulcers of the Lower Extremities

This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers

Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments.

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.