Status:

SUSPENDED

Outcome Assessment in Patients Treated With Hyperbaric Oxygen Using OxyVu Tissue Oxygenation Monitoring System

Lead Sponsor:

HyperMed

Collaborating Sponsors:

Hyperbaric and Wound Care Associates

VA Long Beach Healthcare System

Conditions:

Wounds

Eligibility:

All Genders

18-85 years

Brief Summary

The objective is to define patient eligibility for hyperbaric oxygen therapy and to evaluate wound healing progression using a new hyperspectral imaging technology.

Detailed Description

The purpose of this clinical study is to define patient eligibility for hyperbaric oxygen therapy (HBOT) and to evaluate wound healing progression during HBOT using a new hyperspectral imaging technol...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • 18 - 85 years of age
  • Patients with wounds that meet the criteria for hyperbaric oxygen therapy (e.g. problem wound, diabetic foot ulcer, necrotizing soft tissue infections)
  • Compromised Flap or Grafts.
  • Exclusion criteria:
  • Patients with poor cardiac output (EF \< 20%)
  • Patients with severe obstructive pulmonary disease who don't qualify for HBOT
  • Patients with untreated asthma who don't qualify for HBOT
  • Patients utilizing supplemental oxygen and those on ventilators
  • Patients on life support medications (pressors)

Exclusion

    Key Trial Info

    Start Date :

    August 1 2008

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    November 1 2010

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT00768027

    Start Date

    August 1 2008

    End Date

    November 1 2010

    Last Update

    June 4 2009

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Long Beach Memorial Medical Center

    Long Beach, California, United States, 90822

    2

    Long Beach VA Medical Center

    Long Beach, California, United States, 90822

    3

    Hyperbaric & Wound Care Associates

    Milwaukee, Wisconsin, United States, 53215