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

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00768027

Acronym

HBOT

Enrollment

Registered

2008-10-07

Start date

2008-08-31

Completion date

2010-11-30

Last updated

2009-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounds

Keywords

hyperspectral imaging, tissue oxygenation, wounds, wound healing, prevention, hyperbaric

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 technology (OxyVu).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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)

Design outcomes

Primary

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

Countries

United States

Outcome results