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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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • The Secondary Endpoint Measure is a Reduction on Wound Size. [ Time Frame: 28 days post enrollment ]
    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   (Adult, Senior)
Sexes Eligible for Study:   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.
  Contacts and Locations
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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

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

Additional relevant MeSH terms:
Nitric Oxide
Leg Ulcer
Skin Ulcer
Pathologic Processes
Skin Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents processed this record on August 18, 2017