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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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