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Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia

NCT ID: NCT00224328

Last Updated: 2007-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-01-31

Brief Summary

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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

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Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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ODISsey Tissue Oximeter

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ViOptix Canada

INDUSTRY

Sponsor Role lead

Principal Investigators

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Thomas Lindsay, FRCSC, FACS

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital, University Health Network

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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. doi: 10.1006/jsre.1997.5164.

Reference Type BACKGROUND
PMID: 9344707 (View on PubMed)

Simonson SG, Piantadosi CA. Near-infrared spectroscopy. Clinical applications. Crit Care Clin. 1996 Oct;12(4):1019-29. doi: 10.1016/s0749-0704(05)70290-6.

Reference Type BACKGROUND
PMID: 8902382 (View on PubMed)

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. doi: 10.1152/jappl.1994.77.6.2740.

Reference Type BACKGROUND
PMID: 7896615 (View on PubMed)

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. doi: 10.2106/00004623-199706000-00007.

Reference Type BACKGROUND
PMID: 9199381 (View on PubMed)

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. doi: 10.1002/bjs.1800780408.

Reference Type BACKGROUND
PMID: 2032098 (View on PubMed)

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. doi: 10.1007/978-1-4615-0075-9_66.

Reference Type BACKGROUND
PMID: 14562764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9021624 (View on PubMed)

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.

Reference Type BACKGROUND

Reifsnyder T, Grossman JP, Leers SA. Limb loss after lower extremity bypass. Am J Surg. 1997 Aug;174(2):149-51. doi: 10.1016/s0002-9610(97)90074-x.

Reference Type BACKGROUND
PMID: 9293832 (View on PubMed)

Troeng 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.

Reference Type BACKGROUND
PMID: 8186308 (View on PubMed)

Other Identifiers

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VIO-UHN-001

Identifier Type: -

Identifier Source: org_study_id