The aim of this study is to explore the ability of the non-invasive device ODI-Tech® to monitor changes in microvascular blood flow in patients with lower limb ischemia undergoing the procedure percutaneous transluminal angioplasty (PTA). Microvascular data from patients and healthy case matched controls at baseline will be compared.15 patients and 15 healthy case matched controls will be enrolled.
This clinical investigation is designed as a prospective study of limb skin nutritive capillary perfusion and oxygen extraction in patients with lower limb atherosclerosis and severe symptoms before and following elective PTA. 15 patients with critical lower limb atherosclerosis and ischemia in Rutherford grade 3 - 6 undergoing PTA, as well as 15 healthy case matched controls will be enrolled. Measurements will be performed at baseline, prior to PTA, immediately after PTA, 1 day and 30 days post PTA. Healthy case matched controls will be measured at baseline.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Diffuse reflectance spectroscopy and computer-assisted microscopy.
Oslo University Hospital
Oslo, Norway
RECRUITINGChanges in skin microvascular oxygen saturation (SmvO2)
Time frame: From baseline to 40 days post PTA
Changes in functional Capillary Density (FCD)
Time frame: From baseline to 40 days post PTA.
Incidence of AE/ADE/SAE/SADE/DD
Time frame: From baseline to 40 days post PTA
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