NCT00823095

Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

The Observational Effects of the Topical Application of ViaNOx-H (Gaseous Nitric Oxide) on the Bio-Burden in Chronic Non-Healing Colonized Ulcers of the Lower Extremities

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Chronic Ulcer of Lower Extremity

Interventions

Type	Name	Description
DRUG	Nitric Oxide	Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2009-01-15
• Last updated: 2016-02-26
• Results posted: 2014-05-05

Locations

1 site across 1 country: United States