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

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: NCT00545298
Recruitment Status : Terminated (Strategic direction of the sponsor changed)
First Posted : October 17, 2007
Results First Posted : November 19, 2012
Last Update Posted : November 19, 2012
Information provided by (Responsible Party):
Nitric BioTherapeutics, Inc

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

Condition or disease Intervention/treatment Phase
Venous Ulcers Drug: Nitric Oxide - same dose 6 wks Drug: Nitric Oxide modified treatment Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: A - Standard of Care (control)
Standard of care - dressings and sustained compression only
Experimental: B Same treatment for 6 weeks
200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
Drug: Nitric Oxide - same dose 6 wks
200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound

Experimental: C - modified treatment, 5 wks lower dose
200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
Drug: Nitric Oxide modified treatment
200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound

Primary Outcome Measures :
  1. Wound Healing [ Time Frame: Week 20 ]
    % Re-epithelialization

  2. Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: up to 24 weeks ]
    All reported adverse events, related or unrelated to the study drug.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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:

  • 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.

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): NCT00545298

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United States, Virginia
Retreat Hospital, Wound Healing Center
Richmond, Virginia, United States, 23220
Sponsors and Collaborators
Nitric BioTherapeutics, Inc
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Principal Investigator: Joseph V Boykin, MD HCA Retreat Hospital
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Responsible Party: Nitric BioTherapeutics, Inc Identifier: NCT00545298    
Other Study ID Numbers: CTP 1
First Posted: October 17, 2007    Key Record Dates
Results First Posted: November 19, 2012
Last Update Posted: November 19, 2012
Last Verified: October 2012
Keywords provided by Nitric BioTherapeutics, Inc:
Nitric Oxide
Venous Leg Ulcers
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular 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