Peripheral Vascular DiseaseNIRSNCT01459341
Near Infrared Spectroscopy and Transcutaneous Oxygen Pressure in Critical Limb Ischemia Before and After Treatment
An observational study of Peripheral Vascular Disease and Critical Limb Ischemia, run by Carmel Medical Center at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Vascular Disease, Critical Limb Ischemia
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 10 patients admitted to the vascular surgical department and undergoing invasive treatment (surgical or endovacular)
Who may be able to join
- 10 patients admitted to the vascular surgical department and undergoing invasive treatment (surgical or endovascular)
Who cannot join
- pregnancy allergy to iod advanced renal failure CCT<50 active peptic ulcer recent bleeding
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read the 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.
- Keywords
- CLI Critical limb ischemia, PVD peripheral vascular disease, NIRS near infrared spectroscopy, TCPO2 - transcutaneous oxygen pressure
- Medical subject headings
- Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
tissue oxygenation
Measured: the outcome will be assessed during the hospital stay up to a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dallit Mannheim, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459341
- Sponsor's protocol ID
- CMC-11-0017 CTIL
- Other IDs
- NIRS-001-Carmel
- Acronym
- NIRS
- Status last verified
- Dec 2012
- First submitted
- 18 Oct 2011
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20007987
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01459341
- Acronym / sponsor ID
- NIRS / CMC-11-0017 CTIL
- Keywords
- CLI Critical limb ischemia, PVD peripheral vascular disease, NIRS near infrared spectroscopy, TCPO2 - transcutaneous oxygen pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 10 patients admitted to the vascular surgical department and undergoing invasive treatment (surgical or endovacular)
Key inclusion criteria (1 listed)
- 10 patients admitted to the vascular surgical department and undergoing invasive treatment (surgical or endovascular)
Key exclusion criteria (1 listed)
- pregnancy allergy to iod advanced renal failure CCT<50 active peptic ulcer recent bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tissue oxygenation
Time frame: the outcome will be assessed during the hospital stay up to a week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
- Results publication: PubMed 20007987Murkin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dallit Mannheim, MD principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Disease and Critical Limb Ischemia, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tissue oxygenation (time frame: the outcome will be assessed during the hospital stay up to a week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01459341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2012; AzTrials last refreshed its copy on 8 Nov 2026.