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: NCT00613808
Recruitment Status : Terminated
First Posted : February 13, 2008
Last Update Posted : January 25, 2012
Information provided by (Responsible Party):
Nitric BioTherapeutics, Inc

Brief Summary:
The purpose of this study is to determine whether nitric oxide (NO)gas is effective in the treatment of venous ulcers of the lower leg.

Condition or disease Intervention/treatment Phase
Venous Ulcers Drug: Nitric Oxide 200ppm Group B Phase 2

Detailed Description:
SUbjects were divided into two Groups - one receiving 200ppm NO gas delivered topically to the wound area for 8 hours a day for 6 weeks. The other Group (control arm) received Standard of Care (compression) for 22 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Investigation of Topical Application of Gaseous Nitric Oxide on Safety and Efficacy in Venous Stasis Ulcers of the Lower Extremities
Study Start Date : February 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: A - Standard of Care (control)
Standard of care - dressings and sustained compression only for the two week screening period and then for 20 weeks thereafter
Active Comparator: B Same treatment for 6 weeks, 200ppm NO gas
Subjects were treated by topical application of 200ppm Nitric Oxide gas delivered to the wound area for 8 hours per day for 6 weeks
Drug: Nitric Oxide 200ppm Group B
200 ppm, 8hrs / day for 6 weeks

Primary Outcome Measures :
  1. Effect of daily application of Nitric Oxide on rate of closure in venous ulcers [ Time Frame: 24 weeks or wound closure ]

Secondary Outcome Measures :
  1. Change in quality of life [ Time Frame: 24 weeks or wound closure ]
  2. Incidence of adverse events [ Time Frame: 24 weeks or wound closure ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must have given written informed consent and HIPAA authorization
  • Must be ≥ 18 years of age
  • Must have a venous ulcer for 60 days or greater
  • ABPI > 0.8 and ≤ 1.2
  • Must have ulcer between 3cm2 and 25cm2 in size

Exclusion Criteria:

  • Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency
  • BMI ≥ 35
  • Has evidence of clinical infection
  • Suffers from diabetes mellitus with HbA1c ≥ 8%
  • Suffers from clinically significant arterial disease
  • Has a known allergy to any of the compounds / drugs that are part of this protocol
  • Has evidence of the ulcer and / or infection extending to the underlying muscle, tendon or bone
  • Has used any investigational drug(s) within 30 days preceding randomization
  • Is unable to manage self-treatment
  • Is pregnant, nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
  • Suffers from a condition which in the opinion of the Investigator would compromise the safety of the subject and / or the quality of the data
  • Is using any of the prohibited concomitant medications or treatments
  • Has previously participated in this study

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): NCT00613808

United States, Colorado
Diabetic Foot & Wound Center
Denver, Colorado, United States, 80220
United States, Texas
Alamo Podiatry Associates
San Antonio, Texas, United States, 78211
Sponsors and Collaborators
Nitric BioTherapeutics, Inc
Principal Investigator: Jeffrey Jensen, DPM Private Practice, Denver, CO

Responsible Party: Nitric BioTherapeutics, Inc Identifier: NCT00613808     History of Changes
Other Study ID Numbers: CTP 3
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: January 25, 2012
Last Verified: January 2012

Keywords provided by Nitric BioTherapeutics, Inc:

Additional relevant MeSH terms:
Varicose Ulcer
Postphlebitic Syndrome
Postthrombotic Syndrome
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Peripheral Vascular Diseases
Venous Insufficiency
Venous Thrombosis
Embolism and Thrombosis
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