NCT00767923

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

Clinical Validation of HyperMed OxyVu Tissue Oximeter for Assessing Level of Amputation With Comparison to Other Modalities

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: HyperMed · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Critical Limb Ischemia

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-02-01
• Completion: 2010-02-01
• First posted: 2008-10-07
• Last updated: 2009-06-04

Locations

1 site across 1 country: United States