Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers

This study has been terminated.

First Received: October 16, 2007 Last Updated: April 21, 2009 History of Changes

Sponsored by:	Nitric BioTherapeutics, Inc
Information provided by:	Nitric BioTherapeutics, Inc
ClinicalTrials.gov Identifier:	NCT00545298

Purpose

This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers

Condition	Intervention	Phase
Venous Ulcers	Drug: Nitric Oxide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Investigation of the Topical Application of Gaseous Nitric Oxide on Safety and Efficacy in Venous Stasis Leg Ulcers of the Lower Extremities

Resource links provided by NLM:

MedlinePlus related topics: Leg Injuries and Disorders

Drug Information available for: Nitric oxide

U.S. FDA Resources

Further study details as provided by Nitric BioTherapeutics, Inc:

Primary Outcome Measures:

Measurement of endogenous nitric oxide bioactivity [ Time Frame: Baseline, weeks 1, 3,6, 12 and 20 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: No Intervention Standard of care - dressings and sustained compression only
B: Experimental	Drug: Nitric Oxide 200ppm, 8hrs / day for 6 weeks
C: Experimental	Drug: Nitric Oxide 200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks

Detailed Description:

Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments.

Eligibility

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

Criteria

Inclusion Criteria:

Must have a venous stasis ulcer between the knee and the ankle.
Ulcer duration must be 60 days or greater

Exclusion Criteria:

Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency
Suffers from diabetes mellitus with HbA1c ≥ 8%
Suffers from clinically significant arterial disease
Is pregnant, a nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinent)

The above is a partial list of the inclusion and exclusion criteria; however, other inclusion and exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545298

Locations

United States, Virginia
Retreat Hospital, Wound Healing Center
Richmond, Virginia, United States, 23220

Sponsors and Collaborators

Nitric BioTherapeutics, Inc

Investigators

Principal Investigator:

Joseph V Boykin, MD

HCA Retreat Hospital

More Information

No publications provided

Responsible Party:	Nitric BioTherapeutics Inc ( CEO )
Study ID Numbers:	CTP 1
Study First Received:	October 16, 2007
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00545298 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nitric BioTherapeutics, Inc:

Nitric Oxide
Venous Leg Ulcers

Study placed in the following topic categories:

Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Skin Diseases
Ulcer
Vascular Diseases
Anti-Asthmatic Agents
Cardiovascular Agents
Postthrombotic Syndrome

Nitric Oxide
Varicose Ulcer
Varicose Veins
Peripheral Nervous System Agents
Skin Ulcer
Bronchodilator Agents
Postphlebitic Syndrome
Leg Ulcer

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Vasodilator Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Pathologic Processes
Varicose Veins
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Cardiovascular Diseases
Skin Diseases

Ulcer
Vascular Diseases
Anti-Asthmatic Agents
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Nitric Oxide
Varicose Ulcer
Autonomic Agents
Peripheral Nervous System Agents
Skin Ulcer
Bronchodilator Agents
Leg Ulcer

ClinicalTrials.gov processed this record on July 02, 2009