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

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ClinicalTrials.gov 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
Sponsor:
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.

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
Primary Completion Date : November 2008
Study Completion Date : November 2008

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
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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nitric BioTherapeutics, Inc
ClinicalTrials.gov Identifier: NCT00545298     History of Changes
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:
Ulcer
Leg Ulcer
Varicose Ulcer
Postphlebitic Syndrome
Postthrombotic Syndrome
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Phlebitis
Peripheral Vascular Diseases
Venous Insufficiency
Venous Thrombosis
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
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents