Chronic Limb Ischemia, Non-Healing Ulcers
Conditions
Keywords
revascularization, claudication, hyperspectral, oxygenation, limb ischemia
Brief summary
This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.
Detailed description
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.
Interventions
None listed
Sponsors
Cardiac, Vascular & Thoracic Surgery Associates, P.C. (CVTSA)
HyperMed
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Countries
United States
Contacts
Primary ContactKevin Scomacker, PhD
Outcome results
None listed