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

January 24, 2012 updated by: Nitric BioTherapeutics, Inc

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80220
        • Diabetic Foot & Wound Center
    • Texas
      • San Antonio, Texas, United States, 78211
        • Alamo Podiatry Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of daily application of Nitric Oxide on rate of closure in venous ulcers
Time Frame: 24 weeks or wound closure
24 weeks or wound closure

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in quality of life
Time Frame: 24 weeks or wound closure
24 weeks or wound closure
Incidence of adverse events
Time Frame: 24 weeks or wound closure
24 weeks or wound closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nitric BioTherapeutics, Inc

Investigators

  • Principal Investigator: Jeffrey Jensen, DPM, Private Practice, Denver, CO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

January 30, 2008

First Submitted That Met QC Criteria

January 30, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

January 25, 2012

Last Update Submitted That Met QC Criteria

January 24, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP 3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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