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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
Sponsor:
Information provided by:
ViOptix Canada

Tracking Information
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Estimated Enrollment
 (submitted: September¬†13,¬†2005)
100
Original Enrollment Same as current
Actual Study Completion Date January 2007
Primary Completion Date Not Provided
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
Sex/Gender
Sexes Eligible for Study: All
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
Principal Investigator: Thomas Lindsay, FRCSC, FACS Toronto General Hospital, University Health Network
PRS Account ViOptix Canada
Verification Date September 2007