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NCT00224328 Clinical Trial

Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00224328
Other study ID # VIO-UHN-001
Secondary ID
Status Terminated
Phase Phase 2
First received September 13, 2005
Last updated September 11, 2007
Start date August 2005
Est. completion date January 2007

Study information
Verified date September 2007
Source ViOptix Canada
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Therapeutic Products Directorate
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 100
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Device:
• ODISsey Tissue Oximeter

Locations
Country Name City State
Canada Toronto General Hospital Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
ViOptix Canada

Country where clinical trial is conducted

Canada, 

References & Publications (10)

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Simonson SG, Piantadosi CA. Near-infrared spectroscopy. Clinical applications. Crit Care Clin. 1996 Oct;12(4):1019-29. Review. — View Citation

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. — View Citation

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