Critical Limb IschemiaLOANCT00767923

Validation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities

An observational study of Critical Limb Ischemia, run by HyperMed at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

Correlation of(OxyVu) values to to ABI, TBP, and TCOM in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Critical Limb Ischemia
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Jul 2008to Feb 2010
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 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: 18 to 85 years of age, males and females, varying skin tones, varying racial origins, and with and without diabetes.

Who may be able to join

18 to 85 years of age, males and females, varying skin tones, varying racial origins, and with and without diabetes.
Patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Carl T Hayden VA Medical Center
Phoenix, Arizona, 85012

Other trials in United States

About this study

Official title: Clinical Validation of HyperMed OxyVu Tissue Oximeter for Assessing Level of Amputation With Comparison to Other Modalities

Correlation of(OxyVu) values to to ABI, TBP, and TCOM in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Read the detailed description

The purpose of this clinical study is to correlate tissue oxygenation values measured with a hyperspectral imaging system (OxyVu) to Ankle Brachial Indices (ABI), toe pressures (TBP), and transcutaneous oxygen monitoring (TCOM) in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Conditions: Critical Limb Ischemia
Keywords: hyperspectral imaging, tissue oxygenation, foot amputation, critical limb ischemia, tissue necrosis
Medical subject headings: Chronic Limb-Threatening Ischemia

What is being measured

The primary outcome is the main question the study is designed to answer.

Assess predictive value for healing by 8 weeks of OxyVu, ABI, TBI and TCOM measured prior to amputation. OxyVu readings for oxyhemoglobin, deoxyhemoglobin and oxygen saturation will be compared to healing potential predicted from ABI, TBI, and TCOM.
Measured: 8 weeks

Secondary outcomes (1)

Collect additional interventions required through review of patient medical records at 12 months
Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Feb 2010

First posted7 Oct 2008 (estimated)
Study startJul 2008
Primary completionFeb 2009
Study completionFeb 2010 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Critical Limb IschemiaStudies 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: Cohort
Time perspective: Prospective
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00767923
Sponsor's protocol ID: 2008-011
Acronym: LOA
Status last verified: Jun 2009
First submitted: 6 Oct 2008
Last updated: 4 Jun 2009
Results posted: No
Data monitoring committee: No

Publications

Second European Consensus Document on chronic critical leg ischemia. Eur J Vasc Surg. 1992 May;6 Suppl A:1-32. No abstract available.
PubMed 1533191
Deerochanawong C, Home PD, Alberti KG. A survey of lower limb amputation in diabetic patients. Diabet Med. 1992 Dec;9(10):942-6. doi: 10.1111/j.1464-5491.1992.tb01736.x.
PubMed 1478041
Frykberg RG. Guidelines for diabetic foot care. Foot Ankle Int. 2000 Jul;21(7):616. doi: 10.1177/107110070002100716. No abstract available.
PubMed 10919631
Ramsey SD, Newton K, Blough D, McCulloch DK, Sandhu N, Reiber GE, Wagner EH. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999 Mar;22(3):382-7. doi: 10.2337/diacare.22.3.382.
PubMed 10097914
Harrington C, Zagari MJ, Corea J, Klitenic J. A cost analysis of diabetic lower-extremity ulcers. Diabetes Care. 2000 Sep;23(9):1333-8. doi: 10.2337/diacare.23.9.1333.
PubMed 10977028
Greenman RL, Panasyuk S, Wang X, Lyons TE, Dinh T, Longoria L, Giurini JM, Freeman J, Khaodhiar L, Veves A. Early changes in the skin microcirculation and muscle metabolism of the diabetic foot. Lancet. 2005 Nov 12;366(9498):1711-7. doi: 10.1016/S0140-6736(05)67696-9.
PubMed 16291064
Zuzak KJ, Schaeberle MD, Gladwin MT, Cannon RO 3rd, Levin IW. Noninvasive determination of spatially resolved and time-resolved tissue perfusion in humans during nitric oxide inhibition and inhalation by use of a visible-reflectance hyperspectral imaging technique. Circulation. 2001 Dec 11;104(24):2905-10. doi: 10.1161/hc4901.100525.
PubMed 11739304
Khaodhiar L, Dinh T, Schomacker KT, Panasyuk SV, Freeman JE, Lew R, Vo T, Panasyuk AA, Lima C, Giurini JM, Lyons TE, Veves A. The use of medical hyperspectral technology to evaluate microcirculatory changes in diabetic foot ulcers and to predict clinical outcomes. Diabetes Care. 2007 Apr;30(4):903-10. doi: 10.2337/dc06-2209. Epub 2007 Feb 15.
PubMed 17303790
Benaron DA, Parachikov IH, Friedland S, Soetikno R, Brock-Utne J, van der Starre PJ, Nezhat C, Terris MK, Maxim PG, Carson JJ, Razavi MK, Gladstone HB, Fincher EF, Hsu CP, Clark FL, Cheong WF, Duckworth JL, Stevenson DK. Continuous, noninvasive, and localized microvascular tissue oximetry using visible light spectroscopy. Anesthesiology. 2004 Jun;100(6):1469-75. doi: 10.1097/00000542-200406000-00019.
PubMed 15166566

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
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Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon

All Critical Limb Ischemia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Validation of HyperMed OxyVu Tissue Oximeter for Assessing Level of Amputation With Comparison to Other Modalities
ClinicalTrials.gov ID: NCT00767923
Acronym / sponsor ID: LOA / 2008-011
Conditions: Critical Limb Ischemia
Keywords: hyperspectral imaging, tissue oxygenation, foot amputation, critical limb ischemia, tissue necrosis
Study type: Observational
Recruitment status: Unknown status
Enrolment: 20 participants (actual)
Lead sponsor: HyperMedIndustry (pharma, biotech, devices)
Collaborators: Carl T. Hayden VA Medical Center
Study start: Jul 2008
Primary completion: Feb 2009 (actual)
Study completion: Feb 2010 (estimated)
First posted: 7 Oct 2008 (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.

Correlation of(OxyVu) values to to ABI, TBP, and TCOM in patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: 18 to 85 years of age, males and females, varying skin tones, varying racial origins, and with and without diabetes.

Key inclusion criteria (2 listed)

18 to 85 years of age, males and females, varying skin tones, varying racial origins, and with and without diabetes.
Patients scheduled for foot level amputation because of critical limb ischemia, infection, or tissue necrosis.

Key exclusion criteria (0 listed)

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

Assess predictive value for healing by 8 weeks of OxyVu, ABI, TBI and TCOM measured prior to amputation. OxyVu readings for oxyhemoglobin, deoxyhemoglobin and oxygen saturation will be compared to healing potential predicted from ABI, TBI, and TCOM.
Time frame: 8 weeks

1 secondary outcome

Collect additional interventions required through review of patient medical records at 12 months
Time frame: 12 Months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2009.
Background: PubMed 1533191Second European Consensus Document on chronic critical leg ischemia. Eur J Vasc Surg. 1992 May;6 Suppl A:1-32. No abstract available.
Background: PubMed 1478041Deerochanawong C, Home PD, Alberti KG. A survey of lower limb amputation in diabetic patients. Diabet Med. 1992 Dec;9(10):942-6. doi: 10.1111/j.1464-5491.1992.tb01736.x.
Background: PubMed 10919631Frykberg RG. Guidelines for diabetic foot care. Foot Ankle Int. 2000 Jul;21(7):616. doi: 10.1177/107110070002100716. No abstract available.
Background: PubMed 10097914Ramsey SD, Newton K, Blough D, McCulloch DK, Sandhu N, Reiber GE, Wagner EH. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999 Mar;22(3):382-7. doi: 10.2337/diacare.22.3.382.
Background: PubMed 10977028Harrington C, Zagari MJ, Corea J, Klitenic J. A cost analysis of diabetic lower-extremity ulcers. Diabetes Care. 2000 Sep;23(9):1333-8. doi: 10.2337/diacare.23.9.1333.
Background: PubMed 16291064Greenman RL, Panasyuk S, Wang X, Lyons TE, Dinh T, Longoria L, Giurini JM, Freeman J, Khaodhiar L, Veves A. Early changes in the skin microcirculation and muscle metabolism of the diabetic foot. Lancet. 2005 Nov 12;366(9498):1711-7. doi: 10.1016/S0140-6736(05)67696-9.
Background: PubMed 11739304Zuzak KJ, Schaeberle MD, Gladwin MT, Cannon RO 3rd, Levin IW. Noninvasive determination of spatially resolved and time-resolved tissue perfusion in humans during nitric oxide inhibition and inhalation by use of a visible-reflectance hyperspectral imaging technique. Circulation. 2001 Dec 11;104(24):2905-10. doi: 10.1161/hc4901.100525.
Background: PubMed 17303790Khaodhiar L, Dinh T, Schomacker KT, Panasyuk SV, Freeman JE, Lew R, Vo T, Panasyuk AA, Lima C, Giurini JM, Lyons TE, Veves A. The use of medical hyperspectral technology to evaluate microcirculatory changes in diabetic foot ulcers and to predict clinical outcomes. Diabetes Care. 2007 Apr;30(4):903-10. doi: 10.2337/dc06-2209. Epub 2007 Feb 15.
Background: PubMed 15166566Benaron DA, Parachikov IH, Friedland S, Soetikno R, Brock-Utne J, van der Starre PJ, Nezhat C, Terris MK, Maxim PG, Carson JJ, Razavi MK, Gladstone HB, Fincher EF, Hsu CP, Clark FL, Cheong WF, Duckworth JL, Stevenson DK. Continuous, noninvasive, and localized microvascular tissue oximetry using visible light spectroscopy. Anesthesiology. 2004 Jun;100(6):1469-75. doi: 10.1097/00000542-200406000-00019.
Sponsor and OxyVu technology websiteLink provided by the sponsor.

Related trials for Critical Limb Ischemia

RecruitingObservational study
miRNAs in Critical Limb Ischemia (miRNACLI)
Critical Limb Ischemia
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon

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.

Robert G Frykberg, DPM MPH principal investigator

Carl T. Hayden VA 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 Critical Limb Ischemia, run by HyperMed at 1 site in United States.

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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 4 Jun 2009. 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 United States. 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?

Results are not available in the source record.

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?

Assess predictive value for healing by 8 weeks of OxyVu, ABI, TBI and TCOM measured prior to amputation. OxyVu readings for oxyhemoglobin, deoxyhemoglobin and oxygen saturation will be compared to healing potential predicted from ABI, TBI, and TCOM. (time frame: 8 weeks). 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 NCT00767923, which also lists 9 linked publications.

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 4 Jun 2009.