Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

This study has been terminated.
(Subject recuitment halted and won't resume; subjects are no longer being treated.)
Nitric BioTherapeutics, Inc
Information provided by (Responsible Party):
Loma Linda University Identifier:
First received: January 13, 2009
Last updated: January 28, 2016
Last verified: April 2014
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.

Condition Intervention Phase
Chronic Ulcer of Lower Extremity
Drug: Nitric Oxide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Secondary Endpoint Measure is a Reduction on Wound Size. [ Time Frame: 28 days post enrollment ] [ Designated as safety issue: No ]
    reduction in bioburden as assessed by number of cfu's per cm2 on culture

Enrollment: 7
Study Start Date: December 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topically applied Nitric Oxide
Topically applied Nitric Oxide for 8 hours daily for 2 weeks.
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

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
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Please refer to this study by its identifier: NCT00823095

United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Nitric BioTherapeutics, Inc
Principal Investigator: Takkin Lo, MD, MPH Loma Linda University Medical Center
  More Information

Responsible Party: Loma Linda University Identifier: NCT00823095     History of Changes
Other Study ID Numbers: TNO-1B  DMF 15551  IND 68617 
Study First Received: January 13, 2009
Results First Received: August 2, 2013
Last Updated: January 28, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Loma Linda University:
chronic cutaneous ulcers
Nitric Oxide
topically applied
Colonized chronic non-healing ulcers

Additional relevant MeSH terms:
Leg Ulcer
Skin Ulcer
Skin Diseases
Nitric Oxide
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Endothelium-Dependent Relaxing Factors
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Vasodilator Agents processed this record on May 25, 2016