Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia
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ClinicalTrials.gov 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
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Tracking Information | ||||
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First Submitted Date | September 13, 2005 | |||
First Posted Date | September 22, 2005 | |||
Last Update Posted Date | September 12, 2007 | |||
Study Start Date | August 2005 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures | Not Provided | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | 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 | |||
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. |
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Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Defined Population Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Not Provided | |||
Study Population | Not Provided | |||
Condition | Peripheral Arterial Disease | |||
Intervention | Device: ODISsey Tissue Oximeter | |||
Study Groups/Cohorts | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Terminated | |||
Estimated Enrollment |
100 | |||
Original Enrollment | Same as current | |||
Actual Study Completion Date | January 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00224328 | |||
Other Study ID Numbers | VIO-UHN-001 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor | ViOptix Canada | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | ViOptix Canada | |||
Verification Date | September 2007 |