Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00823095
Recruitment Status : Terminated (Subject recuitment halted and won't resume; subjects are no longer being treated.)
First Posted : January 15, 2009
Results First Posted : May 5, 2014
Last Update Posted : February 26, 2016
Nitric BioTherapeutics, Inc
Information provided by (Responsible Party):
Loma Linda University

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.

Condition or disease Intervention/treatment Phase
Chronic Ulcer of Lower Extremity Drug: Nitric Oxide Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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
Study Start Date : December 2005
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Loma Linda University Identifier: NCT00823095     History of Changes
Other Study ID Numbers: TNO-1B
DMF 15551
IND 68617
First Posted: January 15, 2009    Key Record Dates
Results First Posted: May 5, 2014
Last Update Posted: February 26, 2016
Last Verified: April 2014

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
Pathologic Processes
Skin Diseases
Nitric Oxide
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