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

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

The purpose of this study is to determine whether nitric oxide (NO)gas is effective in the treatment of venous ulcers of the lower leg.

SUbjects were divided into two Groups - one receiving 200ppm NO gas delivered topically to the wound area for 8 hours a day for 6 weeks. The other Group (control arm) received Standard of Care (compression) for 22 weeks.

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