Validation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities
NCT ID: NCT00767923
Last Updated: 2009-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2008-07-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.
18 Years
85 Years
ALL
Yes
Sponsors
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Carl T. Hayden VA Medical Center
FED
HyperMed
INDUSTRY
Responsible Party
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HyperMed, Inc.
Principal Investigators
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Robert G Frykberg, DPM MPH
Role: PRINCIPAL_INVESTIGATOR
Carl T. Hayden VA Medical Center
Locations
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Carl T Hayden VA Medical Center
Phoenix, Arizona, United States
Countries
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References
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Second European Consensus Document on chronic critical leg ischemia. Eur J Vasc Surg. 1992 May;6 Suppl A:1-32. No abstract available.
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.
Frykberg RG. Guidelines for diabetic foot care. Foot Ankle Int. 2000 Jul;21(7):616. doi: 10.1177/107110070002100716. No abstract available.
Ramsey SD, Newton K, Blough D, McCulloch DK, Sandhu N, Reiber GE, Wagner EH. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999 Mar;22(3):382-7. doi: 10.2337/diacare.22.3.382.
Harrington C, Zagari MJ, Corea J, Klitenic J. A cost analysis of diabetic lower-extremity ulcers. Diabetes Care. 2000 Sep;23(9):1333-8. doi: 10.2337/diacare.23.9.1333.
Greenman RL, Panasyuk S, Wang X, Lyons TE, Dinh T, Longoria L, Giurini JM, Freeman J, Khaodhiar L, Veves A. Early changes in the skin microcirculation and muscle metabolism of the diabetic foot. Lancet. 2005 Nov 12;366(9498):1711-7. doi: 10.1016/S0140-6736(05)67696-9.
Zuzak KJ, Schaeberle MD, Gladwin MT, Cannon RO 3rd, Levin IW. Noninvasive determination of spatially resolved and time-resolved tissue perfusion in humans during nitric oxide inhibition and inhalation by use of a visible-reflectance hyperspectral imaging technique. Circulation. 2001 Dec 11;104(24):2905-10. doi: 10.1161/hc4901.100525.
Khaodhiar L, Dinh T, Schomacker KT, Panasyuk SV, Freeman JE, Lew R, Vo T, Panasyuk AA, Lima C, Giurini JM, Lyons TE, Veves A. The use of medical hyperspectral technology to evaluate microcirculatory changes in diabetic foot ulcers and to predict clinical outcomes. Diabetes Care. 2007 Apr;30(4):903-10. doi: 10.2337/dc06-2209. Epub 2007 Feb 15.
Benaron DA, Parachikov IH, Friedland S, Soetikno R, Brock-Utne J, van der Starre PJ, Nezhat C, Terris MK, Maxim PG, Carson JJ, Razavi MK, Gladstone HB, Fincher EF, Hsu CP, Clark FL, Cheong WF, Duckworth JL, Stevenson DK. Continuous, noninvasive, and localized microvascular tissue oximetry using visible light spectroscopy. Anesthesiology. 2004 Jun;100(6):1469-75. doi: 10.1097/00000542-200406000-00019.
Related Links
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Sponsor and OxyVu technology website
Other Identifiers
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2008-011
Identifier Type: -
Identifier Source: org_study_id
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