Hyperspectral Imaging Pre and Post Endovascular Intervention

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

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-12-31

Brief Summary

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This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.

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Detailed Description

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This will be a nonrandomized, nonblinded, prospective observational study to correlate the results obtained with the traditional measures of success of endovascular revascularization of peripheral arteries for the treatment of chronic limb ischemia; i.e., ABPI, PVR with oxyhemoglobin (OxyHb) and deoxyhemoglobin (DeoxyHb) measurements obtained with a new imaging device manufactured by HyperMed Inc (OxyVu) that uses hyperspectral technology.

Conditions

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Chronic Limb Ischemia Non-Healing Ulcers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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One Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Patients with established diagnosis of lower limb ischemic based on their symptoms of claudication, rest pain, non-healing ulcers or gangrene and other vascular laboratory tests that are currently used to make this diagnosis and have been scheduled for endovascular revascularization.
2. Age group between 50-85
3. Gender - Male or Female
4. Race - all race and ethnicities

Exclusion Criteria

1. Patients with known cardiac disease - new MI (within 3 months).
2. Patients with hypertension with the systolic BP \>200 or diastolic BP\>110 on the day of testing
3. Patients on supplemental O2 for chronic obstructive lung disease
4. Bed-ridden subjects - either due to chronic disability or neurological problems

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No