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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Nitric BioTherapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00613808
First received: January 30, 2008
Last updated: January 24, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Venous Ulcers
 Drug: Nitric Oxide 200ppm Group B
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nitric BioTherapeutics, Inc:

Primary Outcome Measures:
  • Effect of daily application of Nitric Oxide on rate of closure in venous ulcers [ Time Frame: 24 weeks or wound closure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in quality of life [ Time Frame: 24 weeks or wound closure ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 24 weeks or wound closure ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: February 2008
Study Completion Date: May 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613808

Locations
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
Investigators
Principal Investigator: Jeffrey Jensen, DPM Private Practice, Denver, CO
  More Information

No publications provided

Responsible Party: Nitric BioTherapeutics, Inc
ClinicalTrials.gov Identifier: NCT00613808     History of Changes
Other Study ID Numbers: CTP 3
Study First Received: January 30, 2008
Last Updated: January 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nitric BioTherapeutics, Inc:
venous
leg
ulcer

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

ClinicalTrials.gov processed this record on June 18, 2013