Outcome Assessment in Patients Treated With Hyperbaric Oxygen Using OxyVu Tissue Oxygenation Monitoring System - Full Text View

Sponsors and Collaborators:	HyperMed, Inc Hyperbaric and Wound Care Associates Long Beach VA Medical Center Long Beach Memorial Medical Center
Information provided by:	HyperMed, Inc
ClinicalTrials.gov Identifier:	NCT00768027

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

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	August 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (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 to 85 years of age
Males and females
Untreatable peripheral vascular disease.

Contacts and Locations

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

Locations

United States, California
Long Beach VA Medical Center	Recruiting
Long Beach, California, United States, 90822
Contact: Robyn Burgess 562-826-8000 ext 2093 robyn.burgess@va.gov
Principal Investigator: Ian L Gordon, MD PhD
Long Beach Memorial Medical Center	Not yet recruiting
Long Beach, California, United States, 90822
Contact: Kay Crosser 562-826-8190 kay.crosser@va.gov
Principal Investigator: Michael B Strauss, MD
United States, Wisconsin
Hyperbaric & Wound Care Associates	Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Kathy Nelson 414-385-8722 kathy.nelson@aurora.org
Principal Investigator: Jeffrey Niezgoda, MD

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

Sponsor and OxyVu technology website This link exits the ClinicalTrials.gov site

Publications:

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. No abstract available.

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.

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.

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.

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.

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.

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

Frykberg RG. Guidelines for diabetic foot care. Foot Ankle Int. 2000 Jul;21(7):616. No abstract available.

Responsible Party:	HyperMed, Inc. ( Kevin Schomacker, PhD )
Study ID Numbers:	2008-012
Study First Received:	October 6, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00768027
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 February 06, 2009