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

June 2, 2009 updated by: HyperMed
The objective is to define patient eligibility for hyperbaric oxygen therapy and to evaluate wound healing progression using a new hyperspectral imaging technology.

Study Overview

Status

Suspended

Conditions

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 technology (OxyVu).

Study Type

Observational

Enrollment (Anticipated)

60

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
    • California
      • Long Beach, California, United States, 90822
        • Long Beach VA Medical Center
      • Long Beach, California, United States, 90822
        • Long Beach Memorial Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Hyperbaric & Wound Care 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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

18 to 85 years of age, males and females, and with and without diabetes and untreatable peripheral vascular disease.

Description

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)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
OxyVu measurements will be compared to transcutaneous oxygen measurements pre and post HBOT
Time Frame: Days 1, 7, 14, 21, 4wks, and 2 months
Days 1, 7, 14, 21, 4wks, and 2 months

Collaborators and Investigators

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

Sponsor

HyperMed

Collaborators

Hyperbaric and Wound Care Associates
VA Long Beach Healthcare System
Long Beach Memorial Medical Center

Investigators

  • Principal Investigator: Jeffrey Niezgoda, MD, Hyperbaric & Wound Care Associates
  • Principal Investigator: Ian L Gordon, MD PhD, VA Long Beach Healthcare System
  • Principal Investigator: Michael B Strauss, MD, Long Beach Memorial Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

August 1, 2008

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

October 6, 2008

First Submitted That Met QC Criteria

October 6, 2008

First Posted (Estimate)

October 7, 2008

Study Record Updates

Last Update Posted (Estimate)

June 4, 2009

Last Update Submitted That Met QC Criteria

June 2, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2008-012

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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