Clinical trial NCT00224328: Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia
Official title: Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia: A Phase Iia, Non-Randomized Study Using the ODISsey Tissue Oximeter to Evaluate the Correlation Between Tissue Oxygen Saturation and Symptom Resolution in Patients With Chronic Critical Limb Ischemia Undergoing Treatment Interventions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Peripheral Arterial Disease
Keywords: Tissue Oxygen Saturation
Peripheral Arterial Disease
Critical Limb Ischemia
Near-infrared Spectroscopy
Lead sponsor: ViOptix Canada
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* \>= 18 years old
* PAD
* Chronic Critical Limb Ischemia
* requiring surgical intervention
* able to give informed consent

Exclusion Criteria:

* emergent/urgent requirement for surgical intervention
* requiring surgical intervention due to acute traumatic injury

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Toronto General Hospital, University Health Network
name: Thomas Lindsay, FRCSC, FACS
role: PRINCIPAL_INVESTIGATOR
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