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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-11-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Peripheral Vascular Disease Critical Limb Ischemia

Keywords

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CLI Critical limb ischemia PVD peripheral vascular disease NIRS near infrared spectroscopy TCPO2 - transcutaneous oxygen pressure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dallit Mannheim, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

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department of vascular surgery, Carmel medical center

Haifa, , Israel

Site Status

Countries

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Israel

References

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Murkin JM, Arango M. Near-infrared spectroscopy as an index of brain and tissue oxygenation. Br J Anaesth. 2009 Dec;103 Suppl 1:i3-13. doi: 10.1093/bja/aep299.

Reference Type RESULT

PMID: 20007987 (View on PubMed)

Other Identifiers

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NIRS-001-Carmel

Identifier Type: OTHER

Identifier Source: secondary_id

CMC-11-0017 CTIL

Identifier Type: -

Identifier Source: org_study_id