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Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia

NCT00224328 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2007-09-12

No results posted yet for this study

Summary

Near-infrared spectroscopy can be used to determine the relative oxygen saturation in tissues up to 2cm below the skin. It has been investigated, with success, in cerebral, gastrointestinal, and muscle tissue, and shows promise in numerous indications involving tissue ischemia. In the current study, we propose to examine one hundred patients requiring either bypass or angioplasty due to chronic critical limb ischemia resulting from peripheral arterial disease. We intend to challenge patients before and after the intervention, using either an inflated blood pressure cuff or toe raises, to determine if oxygen saturation recovery time in the affected limb is correlated with symptom resolution (i.e. treatment success). Near-infrared spectroscopy will be performed using the ODISsey tissue oximeter developed by ViOptix, Inc. The proposed study will take approximately one year to complete enrolment, and has a follow-up period of 6 months post-intervention.

Study Hypothesis: Knowledge of tissue oxygen saturation enhances clinical decision making in patients with chronic critical limb ischemia.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

ODISsey Tissue Oximeter

Sponsors & Collaborators

  • ViOptix Canada

    lead INDUSTRY

Principal Investigators

  • Thomas Lindsay, FRCSC, FACS · Toronto General Hospital, University Health Network

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Completion
2007-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00224328 on ClinicalTrials.gov