Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

Chronic Ulcer of Lower Extremity Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Ulcer of Lower Extremity
• Leg Ulcer
• Skin Ulcer

• NCT number: NCT00823095
• Study type: Interventional
• Source: Loma Linda University
• Status: Terminated
• Phase: Phase 2
• Start date: December 2005
• Completion date: October 2008