NCT01459341

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

1.2 years

First QC Date

October 18, 2011

Last Update Submit

December 5, 2012

Conditions

Peripheral Vascular DiseaseCritical Limb Ischemia

Keywords

CLI Critical limb ischemiaPVD peripheral vascular diseaseNIRS near infrared spectroscopyTCPO2 - transcutaneous oxygen pressure

Outcome Measures

Primary Outcomes (1)

  • tissue oxygenation

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

department of vascular surgery, Carmel medical center

Haifa, Israel

Location

Related Publications (1)

  • 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.

    PMID: 20007987RESULT

MeSH Terms

Conditions

Peripheral Vascular DiseasesChronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPeripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Officials

  • Dallit Mannheim, MD

    Carmel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2011

First Posted

October 25, 2011

Study Start

July 1, 2011

Primary Completion

September 1, 2012

Study Completion

November 1, 2012

Last Updated

December 6, 2012

Record last verified: 2012-12

Locations

IL(1)