Overview

This trial is active, not recruiting.

Condition critical limb ischemia
Sponsor HyperMed, Inc
Collaborator Carl T. Hayden VA Medical Center
Start date July 2008
End date February 2009
Trial size 20 participants
Trial identifier NCT00767923, 2008-011

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

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.
time frame: 8 weeks

Secondary Outcomes

Measure
Collect additional interventions required through review of patient medical records at 12 months
time frame: 12 Months

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2009.
Information provided to ClinicalTrials.gov by HyperMed, Inc.