Validation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities
This trial is active, not recruiting.
|Condition||critical limb ischemia|
|Collaborator||Carl T. Hayden VA Medical Center|
|Start date||July 2008|
|End date||February 2009|
|Trial size||20 participants|
|Trial identifier||NCT00767923, 2008-011|
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.
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.
time frame: 8 weeks
Collect additional interventions required through review of patient medical records at 12 months
time frame: 12 Months
Male or female participants from 18 years up to 85 years old.
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.
|Official title||Clinical Validation of HyperMed OxyVu Tissue Oximeter for Assessing Level of Amputation With Comparison to Other Modalities|
|Principal investigator||Robert G Frykberg, DPM MPH|
|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.|
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