Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia

• ClinicalTrials.gov Identifier: NCT00224328
• Recruitment Status: Terminated
• First Posted: September 22, 2005
• Last Update Posted: September 12, 2007
• Sponsor: ViOptix Canada
• 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
• 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 *

• Kooijman HM, Hopman MT, Colier WN, van der Vliet JA, Oeseburg B. Near infrared spectroscopy for noninvasive assessment of claudication. J Surg Res. 1997 Sep;72(1):1-7.
• Simonson SG, Piantadosi CA. Near-infrared spectroscopy. Clinical applications. Crit Care Clin. 1996 Oct;12(4):1019-29. Review.
• Mancini DM, Bolinger L, Li H, Kendrick K, Chance B, Wilson JR. Validation of near-infrared spectroscopy in humans. J Appl Physiol (1985). 1994 Dec;77(6):2740-7.
• Mohler LR, Styf JR, Pedowitz RA, Hargens AR, Gershuni DH. Intramuscular deoxygenation during exercise in patients who have chronic anterior compartment syndrome of the leg. J Bone Joint Surg Am. 1997 Jun;79(6):844-9.
• Cheatle TR, Potter LA, Cope M, Delpy DT, Coleridge Smith PD, Scurr JH. Near-infrared spectroscopy in peripheral vascular disease. Br J Surg. 1991 Apr;78(4):405-8.
• Jarm T, Kragelj R, Liebert A, Lukasiewitz P, Erjavec T, Preseren-Strukelj M, Maniewski R, Poredos P, Miklavcic D. Postocclusive reactive hyperemia in healthy volunteers and patients with peripheral vascular disease measured by three noninvasive methods. Adv Exp Med Biol. 2003;530:661-9.
• Lee BY, Ostrander E, Karmakar M, Frenkel L, Herz B. Noninvasive quantification of muscle oxygen in subjects with and without claudication. J Rehabil Res Dev. 1997 Jan;34(1):44-51.
• 8. TransAtlantic Inter-Society Consensus Document. (living document, 1999) Management of Peripheral Arterial Disease: Critical Limb Ischemia. http://www.tasc-pad.org/ Arterial Disease. J Vasc Surg; Oct; 38(4): 724-9.
• Reifsnyder T, Grossman JP, Leers SA. Limb loss after lower extremity bypass. Am J Surg. 1997 Aug;174(2):149-51.
• Troëng T, Bergqvist D, Janson L. Incidence and causes of adverse outcomes of operation for chronic ischaemia of the leg. Eur J Surg. 1994 Jan;160(1):17-25.

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

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