Topical Nitric Oxide Trial in Chronic Non-Healing Wounds - Full Text View

Sponsors and Collaborators:	Loma Linda University Nitric BioTherapeutics, Inc
Information provided by:	Loma Linda University
ClinicalTrials.gov Identifier:	NCT00823095

Purpose

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 Non-Healing Ulcers	Drug: Nitric Oxide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
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:

Drug Information available for: Nitric oxide

U.S. FDA Resources

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 ]

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)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823095

Locations

United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354

Sponsors and Collaborators

Loma Linda University

Nitric BioTherapeutics, Inc

Investigators

Principal Investigator:

Takkin Lo, MD, MPH

Loma Linda University Medical Center

More Information

No publications provided

Responsible Party:	Loma Linda University Medical Center ( Takkin Lo, MD )
Study ID Numbers:	TNO-1B, DMF 15551, IND 68617
Study First Received:	January 13, 2009
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00823095 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Loma Linda University:

chronic cutaneous ulcers
Nitric Oxide
topically applied
Biofilm
Colonized chronic non-healing ulcers

Study placed in the following topic categories:

Nitric Oxide
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Ulcer

Anti-Asthmatic Agents
Cardiovascular Agents
Peripheral Nervous System Agents
Skin Ulcer
Bronchodilator Agents

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Ulcer
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents
Protective Agents

Pharmacologic Actions
Nitric Oxide
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on September 01, 2009