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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01459341
First received: October 18, 2011
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

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).


Condition
Peripheral Vascular Disease
Critical Limb Ischemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • tissue oxygenation [ Time Frame: the outcome will be assessed during the hospital stay up to a week ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: July 2011
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459341

Locations
Israel
department of vascular surgery, Carmel medical center
Haifa, Israel
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Dallit Mannheim, MD Carmel Medical Center
  More Information

Publications:

Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01459341     History of Changes
Other Study ID Numbers: CMC-11-0017 CTIL, NIRS-001-Carmel
Study First Received: October 18, 2011
Last Updated: December 5, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Carmel Medical Center:
CLI Critical limb ischemia
PVD peripheral vascular disease
NIRS near infrared spectroscopy
TCPO2 - transcutaneous oxygen pressure

Additional relevant MeSH terms:
Ischemia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
 Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 22, 2013