Validation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities

• Conditions: Critical Limb Ischemia

• Registration Number: NCT00767923
• Lead Sponsor: HyperMed

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-10-06
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-07
• Primary Completion: 2009-02
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-02
• Last Update Posted: 2009-06-04
• Study Completion: 2010-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	8 weeks

Secondary Outcome Measures

Name	Time	Method
Collect additional interventions required through review of patient medical records at 12 months	12 Months

Trial Locations

Locations (1)

Carl T Hayden VA Medical Center; 🇺🇸 Phoenix, Arizona, United States