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

This study has been terminated.
(Strategic direction of the sponsor changed)
Sponsor:
Information provided by (Responsible Party):
Nitric BioTherapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00545298
First received: October 16, 2007
Last updated: October 18, 2012
Last verified: October 2012
History of Changes
  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 - same dose 6 wks
Drug: Nitric Oxide modified treatment
 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 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:

U.S. FDA Resources

Further study details as provided by Nitric BioTherapeutics, Inc:

Primary Outcome Measures:
  • Wound Healing [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
    % Re-epithelialization

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


Enrollment: 4
Study Start Date: October 2007
Study Completion Date: November 2008
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
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

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
ClinicalTrials.gov Identifier: NCT00545298     History of Changes
Other Study ID Numbers: CTP 1
Study First Received: October 16, 2007
Results First Received: August 8, 2012
Last Updated: October 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nitric BioTherapeutics, Inc:
Nitric Oxide
Venous Leg Ulcers

Additional relevant MeSH terms:
Leg Ulcer
Postphlebitic Syndrome
Postthrombotic Syndrome
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases
Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
 Pathologic Processes
Varicose Veins
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 May 16, 2013