Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224328
Status:
TERMINATED
Last Update Posted:
2007-09-12
First Post:
2005-09-13
Brief Title:
Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia
Sponsor:
ViOptix Canada
Organization:
ViOptix Canada
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The results were not able to be consistantly reproduced Thus the trial was terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
Study Hypothesis Knowledge of tissue oxygen saturation enhances clinical decision making in patients with chronic critical limb ischemia
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None