Text Size

Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

This study has been terminated.
(Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.)
Sponsor:
Collaborator:
Nitric BioTherapeutics, Inc
Information provided by:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00823095
First received: January 13, 2009
Last updated: May 4, 2011
Last verified: March 2010
History of Changes
  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 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:

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:
    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.
  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: Takkin Lo, MD, Loma Linda University Medical Center
ClinicalTrials.gov Identifier: NCT00823095     History of Changes
Other Study ID Numbers: TNO-1B, DMF 15551, IND 68617
Study First Received: January 13, 2009
Last Updated: May 4, 2011
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

Additional relevant MeSH terms:
Ulcer
Pathologic Processes
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
 Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013