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Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00224328
Recruitment Status : Terminated (The results were not able to be consistantly reproduced. Thus the trial was terminated)
First Posted : September 22, 2005
Last Update Posted : September 12, 2007
Information provided by:
ViOptix Canada

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.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Device: ODISsey Tissue Oximeter

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Defined Population
Time Perspective: Prospective
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 Start Date : August 2005
Actual Study Completion Date : January 2007

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00224328

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Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
ViOptix Canada
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Principal Investigator: Thomas Lindsay, FRCSC, FACS Toronto General Hospital, University Health Network
8. TransAtlantic Inter-Society Consensus Document. (living document, 1999) Management of Peripheral Arterial Disease: Critical Limb Ischemia. Arterial Disease. J Vasc Surg; Oct; 38(4): 724-9.

Layout table for additonal information Identifier: NCT00224328    
Other Study ID Numbers: VIO-UHN-001
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 12, 2007
Last Verified: September 2007
Keywords provided by ViOptix Canada:
Tissue Oxygen Saturation
Peripheral Arterial Disease
Critical Limb Ischemia
Near-infrared Spectroscopy
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases