Expired Study
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Loma Linda, California 92354


Purpose:

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 summary:

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.


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 evidencs of the ulcer or infection extending to the underlying muscle or bone. - Are pregnant. - Are less than 18 years of age.


NCT ID:

NCT00823095


Primary Contact:

Principal Investigator
Takkin Lo, MD, MPH
Loma Linda University Medical Center


Backup Contact:

N/A


Location Contact:

Loma Linda, California 92354
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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