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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

October 16, 2007
October 18, 2012
October 2007
November 2008   (final data collection date for primary outcome measure)
  • 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.
Measurement of endogenous nitric oxide bioactivity [ Time Frame: Baseline, weeks 1, 3,6, 12 and 20 ]
Complete list of historical versions of study NCT00545298 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers
An Investigation of the Topical Application of Gaseous Nitric Oxide on Safety and Efficacy in Venous Stasis Leg Ulcers of the Lower Extremities

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

Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Ulcers
  • Drug: Nitric Oxide - same dose 6 wks
    200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered 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
  • 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
    Intervention: Drug: Nitric Oxide - same dose 6 wks
  • 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
    Intervention: Drug: Nitric Oxide modified treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00545298
CTP 1
Yes
Nitric BioTherapeutics, Inc
Nitric BioTherapeutics, Inc
Not Provided
Principal Investigator: Joseph V Boykin, MD HCA Retreat Hospital
Nitric BioTherapeutics, Inc
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP