Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia

This study has been terminated.

(The results were not able to be consistantly reproduced. Thus the trial was terminated)

Sponsor:

Information provided by:

ViOptix Canada

ClinicalTrials.gov Identifier:

NCT00224328

First received: September 13, 2005

Last updated: September 11, 2007

Last verified: September 2007

History of Changes

Purpose

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	Intervention	Phase
Peripheral Arterial Disease	Device: ODISsey Tissue Oximeter	Phase 2

Study Type:	Observational
Study Design:	Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Longitudinal 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

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy Peripheral Arterial Disease

U.S. FDA Resources

Further study details as provided by ViOptix Canada:

Estimated Enrollment:	100
Study Start Date:	August 2005
Study Completion Date:	January 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224328

Locations

Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4

Sponsors and Collaborators

ViOptix Canada

Investigators

Principal Investigator:

Thomas Lindsay, FRCSC, FACS

Toronto General Hospital, University Health Network

More Information

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. 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.

Reifsnyder T, Grossman JP, Leers SA. Limb loss after lower extremity bypass. Am J Surg. 1997 Aug;174(2):149-51.

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.

ClinicalTrials.gov Identifier:	NCT00224328 History of Changes
Other Study ID Numbers:	VIO-UHN-001
Study First Received:	September 13, 2005
Last Updated:	September 11, 2007
Health Authority:	United States: Food and Drug Administration Canada: Therapeutic Products Directorate

Keywords provided by ViOptix Canada:

Tissue Oxygen Saturation
Peripheral Arterial Disease
Critical Limb Ischemia
Near-infrared Spectroscopy

Additional relevant MeSH terms:

Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Atherosclerosis

Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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