Clinical trial NCT00767923: Validation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities
Official title: Clinical Validation of HyperMed OxyVu Tissue Oximeter for Assessing Level of Amputation With Comparison to Other Modalities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Limb Ischemia
Keywords: hyperspectral imaging
tissue oxygenation
foot amputation
critical limb ischemia
tissue necrosis
Lead sponsor: HyperMed
Sponsor class: INDUSTRY
Collaborators: name: Carl T. Hayden VA Medical Center
First posted: 2008-10-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 to 85 years of age, males and females, varying skin tones, varying racial origins, and with and without diabetes.

Brief summary: Correlation of(OxyVu) values to to ABI, TBP, and TCOM in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Detailed description: The purpose of this clinical study is to correlate tissue oxygenation values measured with a hyperspectral imaging system (OxyVu) to Ankle Brachial Indices (ABI), toe pressures (TBP), and transcutaneous oxygen monitoring (TCOM) in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Eligibility criteria: Inclusion Criteria:

* 18 to 85 years of age, males and females, varying skin tones, varying racial origins, and with and without diabetes.
* Patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Primary outcomes:
measure: Assess predictive value for healing by 8 weeks of OxyVu, ABI, TBI and TCOM measured prior to amputation. OxyVu readings for oxyhemoglobin, deoxyhemoglobin and oxygen saturation will be compared to healing potential predicted from ABI, TBI, and TCOM.
timeFrame: 8 weeks
Secondary outcomes:
measure: Collect additional interventions required through review of patient medical records at 12 months
timeFrame: 12 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Carl T Hayden VA Medical Center
state: Arizona
Study officials:
affiliation: Carl T. Hayden VA Medical Center
name: Robert G Frykberg, DPM MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Second European Consensus Document on chronic critical leg ischemia. Eur J Vasc Surg. 1992 May;6 Suppl A:1-32. No abstract available.
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citation: Frykberg RG. Guidelines for diabetic foot care. Foot Ankle Int. 2000 Jul;21(7):616. doi: 10.1177/107110070002100716. No abstract available.
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citation: 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.
citation: 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.
citation: 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.