Topical Nitric Oxide Trial in Chronic Non-Healing Wounds
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|ClinicalTrials.gov Identifier: NCT00823095|
Recruitment Status : Terminated (Subject recuitment halted and won't resume; subjects are no longer being treated.)
First Posted : January 15, 2009
Results First Posted : May 5, 2014
Last Update Posted : February 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Ulcer of Lower Extremity||Drug: Nitric Oxide||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
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 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 ]
- The Secondary Endpoint Measure is a Reduction on Wound Size. [ Time Frame: 28 days post enrollment ]reduction in bioburden as assessed by number of cfu's per cm2 on culture
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|