Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

The primary goal of this study is to determine the effects of topically applied gaseous
nitric oxide on the bio-burden of chronic non-healing wounds of the lower extremities.
Reports will include:

- Comparisons of the demographics and diagnoses of those patients treated with ViaNOx-H.

- Tabulation as to the organisms found and the bio-burden as measured by counts (0 to
+4).

- Tabulation of the number and types of adverse events during ViaNOx-H treatment.

- Comparisons of the response of different organisms to ViaNOx-H treatment.

Inclusion Criteria:

- Have a chronic (> 8 weeks duration) colonized cutaneous ulcer (defined as a wound
containing a local margin of erythema, edema or tenderness; presence of exudates;
and/or presence of a malodorous smell)in their lower extremity (below the knee)
resulting from either diabetes or venous stasis disease.

- Are 18 years of age or older.

Exclusion Criteria:

- Have had a change in their topical treatment during the last 4 weeks

- Have evidence of Clinical Infection

- Have a transcutaneous oxygen tension <30mmHg

- Have evidence of the ulcer or infection extending to the underlying muscle or bone.

- Are pregnant.

- Are less than 18 years of age.