Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

Phase 2TerminatedNCT00823095

Loma Linda University7 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Ulcer of Lower Extremity

Interventions

Nitric OxideDRUG

Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Loma Linda University Medical Center

Loma Linda, California, United States

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.

reduction in bioburden as assessed by number of cfu's per cm2 on culture

Time frame: 28 days post enrollment

Data from ClinicalTrials.gov

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