Topical Nitric Oxide Trial in Chronic Non-Healing Wounds
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2. [ Time Frame: at 28 days post enrollment ] [ Designated as safety issue: No ]
- The Secondary Endpoint Measure is a Reduction on Wound Size. [ Time Frame: 28 days post enrollment ] [ Designated as safety issue: No ]reduction in bioburden as assessed by number of cfu's per cm2 on culture
|Study Start Date:||December 2005|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Experimental: Topically applied Nitric Oxide
Topically applied Nitric Oxide for 8 hours daily for 2 weeks.
Drug: Nitric Oxide
Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823095
|United States, California|
|Loma Linda University Medical Center|
|Loma Linda, California, United States, 92354|
|Principal Investigator:||Takkin Lo, MD, MPH||Loma Linda University Medical Center|