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

Tracking Information

First Received Date ^ICMJE

October 16, 2007

Last Updated Date

April 21, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Measurement of endogenous nitric oxide bioactivity [ Time Frame: Baseline, weeks 1, 3,6, 12 and 20 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Measurement of endogenous nitric oxide bioactivity [ Time Frame: Baseline, weeks 1, 3,6, 12 and 20 ]

Change History

Complete list of historical versions of study NCT00545298 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Investigation of the Topical Application of Gaseous Nitric Oxide on Safety and Efficacy in Venous Stasis Leg Ulcers of the Lower Extremities

Brief Summary

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

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Venous Ulcers

Intervention ^ICMJE

Drug: Nitric Oxide

Study Arms / Comparison Groups

No Intervention: Standard of care - dressings and sustained compression only

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2008

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00545298

Responsible Party

CEO, Nitric BioTherapeutics Inc

Study ID Numbers ^ICMJE

CTP 1

Study Sponsor ^ICMJE

Nitric BioTherapeutics, Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Joseph V Boykin, MD

HCA Retreat Hospital

Information Provided By

Nitric BioTherapeutics, Inc

Verification Date

April 2009

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