Status:
UNKNOWN
Validation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities
Lead Sponsor:
HyperMed
Collaborating Sponsors:
Carl T. Hayden VA Medical Center
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18-85 years
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 transcutaneo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00767923
Start Date
July 1 2008
End Date
February 1 2010
Last Update
June 4 2009
Active Locations (1)
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1
Carl T Hayden VA Medical Center
Phoenix, Arizona, United States, 85012