Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

• Status: Terminated
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by measurements of wound size and wound culture.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loma Linda University
• Collaborator: Nitric BioTherapeutics, Inc
• Treatments: Nitric Oxide

Criteria

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.