Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Ulcer of Lower Extremity

Intervention / Treatment
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* Drug: Nitric Oxide


Participation Criteria
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Eligibility Criteria
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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 evidence of the ulcer or infection extending to the underlying muscle or bone. Are pregnant. Are less than 18 years of age.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topically applied Nitric Oxide<br>Topically applied Nitric Oxide for 8 hours daily for 2 weeks. | Drug: Nitric Oxide<br>* Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.<br>* Other names: gNO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2. |  | at 28 days post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Secondary Endpoint Measure is a Reduction on Wound Size. | reduction in bioburden as assessed by number of cfu's per cm2 on culture | 28 days post enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic cutaneous ulcers, Nitric Oxide, topically applied, Biofilm, Colonized chronic non-healing ulcers