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

This study has suspended participant recruitment.
(Seeking additional funds)
Sponsor:
Collaborators:
Hyperbaric and Wound Care Associates
Long Beach VA Medical Center
Long Beach Memorial Medical Center
Information provided by:
HyperMed, Inc
ClinicalTrials.gov Identifier:
NCT00768027
First received: October 6, 2008
Last updated: June 2, 2009
Last verified: June 2009
  Purpose

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


Condition
Wounds

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcome Assessment in Patients Treated With Hyperbaric Oxygen Using OxyVu Tissue Oxygenation Monitoring System

Resource links provided by NLM:


Further study details as provided by HyperMed, Inc:

Primary Outcome Measures:
  • OxyVu measurements will be compared to transcutaneous oxygen measurements pre and post HBOT [ Time Frame: Days 1, 7, 14, 21, 4wks, and 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768027

Locations
United States, California
Long Beach VA Medical Center
Long Beach, California, United States, 90822
Long Beach Memorial Medical Center
Long Beach, California, United States, 90822
United States, Wisconsin
Hyperbaric & Wound Care Associates
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
HyperMed, Inc
Hyperbaric and Wound Care Associates
Long Beach VA Medical Center
Long Beach Memorial Medical Center
Investigators
Principal Investigator: Jeffrey Niezgoda, MD Hyperbaric & Wound Care Associates
Principal Investigator: Ian L Gordon, MD PhD Long Beach VA Medical Center
Principal Investigator: Michael B Strauss, MD Long Beach Memorial Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Kevin Schomacker, PhD, HyperMed, Inc.
ClinicalTrials.gov Identifier: NCT00768027     History of Changes
Other Study ID Numbers: 2008-012
Study First Received: October 6, 2008
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by HyperMed, Inc:
hyperspectral imaging
tissue oxygenation
wounds
wound healing
prevention
hyperbaric

ClinicalTrials.gov processed this record on July 29, 2014