Trial | NCT00823095  Report issue

Title

Topical Nitric Oxide Trial in Chronic Non-Healing Wounds
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Study Participants

    7
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 Started
Dec 31
2005
Primary Completion
Oct 31
2008
Study Completion
Oct 31
2008
Results Posted
May 05
2014
Estimate
Last Update
Feb 26
2016
Estimate

Drug Nitric Oxide

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

  • Other names: ViaNOx-H, gaseous nitric oxide, gNO

Topically applied Nitric Oxide Experimental

Topically applied Nitric Oxide for 8 hours daily for 2 weeks.

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

Summary

Group 1

All Events

Event Type Organ System Event Term

The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.

Group 1

The Secondary Endpoint Measure is a Reduction on Wound Size.

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

Treatment

Age, Categorical

Evidence of a colonized wound on the lower extremity.

Region of Enrollment

Sex: Female, Male

Overall Study

Topically Applied Nitric Oxide