Near Infrared Spectroscopy and Transcutaneous Oxygen Pressure in Critical Limb Ischemia Before and After Treatment

Comparison of two non-invasive methods for measuring tissue oxygenation. One is Transcutaneous Oxygen Pressure (TCPO2) and the other is the new method of Near Infrared Spectroscopy (NIRS) - near infrared spectroscopy in patients with critical limb ischemia (CLI) undergoing invasive treatment (surgical or endovascular).

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

department of vascular surgery, Carmel medical center

Haifa, Israel

About this study

Comparison of two non-invasive methods for measuring tissue oxygenation. One is TCPO2 and the other is the new method of NIRS - near infrared spectroscopy in patients with critical limb ischemia (CLI) undergoing invasive treatment (surgical or endovascular).

The NIRS probe has been used to measure tissue oxygenation in the cerebral circulation up to now. While TCPO2 is the established method for measuring tissue oxygenation in patients with CLI to evaluate the potential for wound healing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

10 patients admitted to the vascular surgical department and undergoing invasive treatment (surgical or endovascular)

Exclusion criteria

pregnancy allergy to iod advanced renal failure CCT<50 active peptic ulcer recent bleeding

Treatment and study plan

Primary outcomes

tissue oxygenation

Time frame: the outcome will be assessed during the hospital stay up to a week

Sponsors and collaborators

Lead sponsor

Carmel Medical Center

Other

Registry information

Official study title

Comparison of Near Infrared Spectroscopy (NIRS) and Transcutaneous Oxygen Pressure (TCPO2) Measurements in Critical Limb Ischemia (CLI) Patients After Invasive Treatment (Endovascular or Surgery)

Acronym: NIRS

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Oct 25, 2011
Registry last updated: Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed