NCT00823095TerminatedPhase 2
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Loma Linda University
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.
Study Overview
Brief 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.
Detailed 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Topically applied Nitric Oxide
Experimental
Topically applied Nitric Oxide for 8 hours daily for 2 weeks.
Intervention: Nitric Oxide (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- The Secondary Endpoint Measure is a Reduction on Wound Size.(28 days post enrollment)
Investigators
Study Sites (1)
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