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

HyperMed Imaging

Status: Suspended

Conditions: Wounds

Study type: Observational

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT00768027

2008-012

Details and patient eligibility

About

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

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)