Clinical trial NCT00768027: Outcome Assessment in Patients Treated With Hyperbaric Oxygen Using OxyVu Tissue Oxygenation Monitoring System
Official title: Outcome Assessment in Patients Treated With Hyperbaric Oxygen Using OxyVu Tissue Oxygenation Monitoring System
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Wounds
Keywords: hyperspectral imaging
tissue oxygenation
wounds
wound healing
prevention
hyperbaric
Lead sponsor: HyperMed
Sponsor class: INDUSTRY
Collaborators: name: Hyperbaric and Wound Care Associates
name: VA Long Beach Healthcare System
name: Long Beach Memorial Medical Center
First posted: 2008-10-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: OxyVu measurements will be compared to transcutaneous oxygen measurements pre and post HBOT
timeFrame: Days 1, 7, 14, 21, 4wks, and 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Long Beach
country: United States
facility: Long Beach VA Medical Center
state: California
city: Milwaukee
country: United States
facility: Hyperbaric & Wound Care Associates
state: Wisconsin
Study officials:
affiliation: Hyperbaric & Wound Care Associates
name: Jeffrey Niezgoda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Long Beach Healthcare System
name: Ian L Gordon, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Long Beach Memorial Medical Center
name: Michael B Strauss, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1177/1534734606294450. No abstract available.
citation: Niinikoski JH. Clinical hyperbaric oxygen therapy, wound perfusion, and transcutaneous oximetry. World J Surg. 2004 Mar;28(3):307-11. doi: 10.1007/s00268-003-7401-1. Epub 2004 Feb 17.
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. doi: 10.1046/j.1524-475x.2003.11610.x.
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. doi: 10.1046/j.1524-475x.2002.10402.x.
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. doi: 10.1111/j.1524-475X.2007.00234.x.
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.
citation: Deerochanawong C, Home PD, Alberti KG. A survey of lower limb amputation in diabetic patients. Diabet Med. 1992 Dec;9(10):942-6. doi: 10.1111/j.1464-5491.1992.tb01736.x.
citation: Frykberg RG. Guidelines for diabetic foot care. Foot Ankle Int. 2000 Jul;21(7):616. doi: 10.1177/107110070002100716. No abstract available.