Conditions: Chronic Ulcer of Lower Extremity
Keywords: chronic cutaneous ulcers Nitric Oxide topically applied Biofilm Colonized chronic non-healing ulcers
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 7
Healthy volunteers: no

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.

Arms:
arm 1: Topically applied Nitric Oxide for 8 hours daily for 2 weeks.

Interventions: intervention 1: Nitric Oxide
Intervention descriptions: intervention 1: Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.

Protocol document: