Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia

NCT00224328 | Terminated

• 1 other identifier: VIO-UHN-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

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

Interventions

ODISsey Tissue Oximeter DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 18 years old
• PAD
• Chronic Critical Limb Ischemia
• requiring surgical intervention
• able to give informed consent

You may not qualify if:

• emergent/urgent requirement for surgical intervention
• requiring surgical intervention due to acute traumatic injury

Sponsors & Collaborators

• ViOptix Canada: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (10)

• 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.

  PMID: 9344707 BACKGROUND

• 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.

  PMID: 8902382 BACKGROUND

• 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.

  PMID: 7896615 BACKGROUND

• 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.

  PMID: 9199381 BACKGROUND

• 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.

  PMID: 2032098 BACKGROUND

• 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.

  PMID: 14562764 BACKGROUND

• 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.

  PMID: 9021624 BACKGROUND

• 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.

  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.

  PMID: 9293832 BACKGROUND

• 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.

  PMID: 8186308 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Thomas Lindsay, FRCSC, FACS

  Toronto General Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2005
• Study Completion: January 1, 2007
• Last Updated: September 12, 2007

Record last verified: 2007-09

Locations

CA (1)