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.)
Sponsor:
Collaborator:
Nitric BioTherapeutics, Inc
Information provided by (Responsible Party):
Takkin Lo, Loma Linda University
ClinicalTrials.gov Identifier:
NCT00823095
First received: January 13, 2009
Last updated: April 2, 2014
Last verified: April 2014
  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 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.
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Principal Investigator, Loma Linda University
ClinicalTrials.gov 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: April 2, 2014
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
Leg Ulcer
Skin Ulcer
Pathologic Processes
Skin Diseases
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
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on September 16, 2014