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NCT00768027 Clinical Trial

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

Wounds Clinical Trial

— HBOT  

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT00768027
Other study ID # 2008-012
Secondary ID
Status Suspended
Phase N/A
First received October 6, 2008
Last updated June 2, 2009
Start date August 2008
Est. completion date November 2010

Study information
Verified date June 2009
Source HyperMed
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Suspended
Enrollment 60
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Long Beach Memorial Medical Center Long Beach California
United States Long Beach VA Medical Center Long Beach California
United States Hyperbaric & Wound Care Associates Milwaukee Wisconsin

Sponsors (4)
Lead Sponsor Collaborator
HyperMed Hyperbaric and Wound Care Associates, Long Beach Memorial Medical Center, VA Long Beach Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (8)

Deerochanawong C, Home PD, Alberti KG. A survey of lower limb amputation in diabetic patients. Diabet Med. 1992 Dec;9(10):942-6. — View Citation

Fife CE, Buyukcakir C, Otto G, Sheffield P, Love T, Warriner R 3rd. Factors influencing the outcome of lower-extremity diabetic ulcers treated with hyperbaric oxygen therapy. Wound Repair Regen. 2007 May-Jun;15(3):322-31. — View Citation

Fife CE, Buyukcakir C, Otto GH, Sheffield PJ, Warriner RA, Love TL, Mader J. The predictive value of transcutaneous oxygen tension measurement in diabetic lower extremity ulcers treated with hyperbaric oxygen therapy: a retrospective analysis of 1,144 patients. Wound Repair Regen. 2002 Jul-Aug;10(4):198-207. — View Citation

Frykberg RG. Guidelines for diabetic foot care. Foot Ankle Int. 2000 Jul;21(7):616. — View Citation

Mathieu D. Role of hyperbaric oxygen therapy in the management of lower extremity wounds. Int J Low Extrem Wounds. 2006 Dec;5(4):233-5. — View Citation

Niezgoda JA, Mewissen M. The management of lower extremity wounds complicated by acute arterial insufficiency and ischemia. Ostomy Wound Manage. 2004 May;50(5A Suppl):1-11; quiz 12. — View Citation

Niinikoski J. Hyperbaric oxygen therapy of diabetic foot ulcers, transcutaneous oxymetry in clinical decision making. Wound Repair Regen. 2003 Nov-Dec;11(6):458-61. — View Citation

Niinikoski JH. Clinical hyperbaric oxygen therapy, wound perfusion, and transcutaneous oximetry. World J Surg. 2004 Mar;28(3):307-11. Epub 2004 Feb 17. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary OxyVu measurements will be compared to transcutaneous oxygen measurements pre and post HBOT Days 1, 7, 14, 21, 4wks, and 2 months No
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