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Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00224328
Enrollment
100
Registered
2005-09-22
Start date
2005-08-31
Completion date
2007-01-31
Last updated
2007-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

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

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.

Interventions

DEVICEODISsey Tissue Oximeter

Sponsors

ViOptix Canada
Lead SponsorINDUSTRY

Study design

Observational model
DEFINED_POPULATION
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026