Clinical validation of non-invasive tissue perfusion measurements in Vascular diseased patients with PeriFlux 6000 Enhanced Perfusion and Oxygen Saturation (EPOS) system – Pilot study
- Conditions
- Peripheral arterial disease
- Registration Number
- NL-OMON27438
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Healthy volunteers:
- 18 years and older
- Written informed consent
- Rutherford classification 0
Patients with PAD:
- 18 years and older
- Written informed consent
- Claudicants, Rutherford classification 2 and 3.
- Chronic limb-threatening disease, Rutherford classification 4 to 6
Healthy volunteers:
- Investigations or treatment for cardiovascular disease
- Symptoms or history of peripheral neuropathy
Both healthy volunteers and patients with PAD:
- Insufficient knowledge of the Dutch language, illiteracy or language barrier
- Concurrent uncontrolled medical conditions
- Lower leg fractures within the past 12 months.
- (Partial) amputation of one of the feet and/or legs.
- Pregnant or breast feeding.
- Severe peripheral oedema.
- Severe cardiac-pulmonary failure.
- Active cellulitis-erysipelas of the legs or other dermatological diseases.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To develop a standardized and optimized measurement protocol for EPOS measurements, including location on the lower leg, to optimize precision and accuracy of measurements.
- Secondary Outcome Measures
Name Time Method The second objective is to correlate hemoglobin oxygen saturation(%), red blood cell tissue fraction (%) and the speed resolved RBC perfusion separated into three speed regions; 0-1 mm/s, 1-10 mm/s and above 10 mm/s (% mm/s) with TcPO2 in healthy volunteers, claudicants and patients with chronic limb-threatening ischemia.