peripheral atheroslerosis.
Conditions
Interventions
Measurement variation (mean and SD) of MSOT in the lower leg.
Correlation of MSOT oxygenation and perfusion measurements with standard ultrasound imaging of the fixed anatomical landmarks, pulse-oxim
Sponsors
University Medical Center Groningen
Eligibility
Inclusion criteria
Inclusion criteria: Ten (10) healthy volunteers (5 males and 5 females), age >18 years will be asked to participate. - No prior or current medication. - Age >= 18 years. - Written informed consent. - Adequate potential for telephone follow-up 14 days following the measurement with MSOT.
Exclusion criteria
Exclusion criteria: - Medical or psychiatric conditions that compromise the volunteers' ability to give informed consent. - Concurrent uncontrolled medical conditions. - Any investigational treatment for peripheral vascular disease or lower leg fractures within the past month. - Pregnancy or breast feeding. - Clinically significant (i.e. active) cardiovascular disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia, e.g. atrial fibrillation, even if controlled with medication, peripheral vascular disease) or myocardial infarction within the past 12 months. - Patients with symptoms or history of peripheral neuropathy. - (Partial) amputation of one of the legs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are to determine measurement variation (mean and SD) of MSOT in physiological perfused lower leg. | — |
Secondary
| Measure | Time frame |
|---|---|
| Information on safety aspects of the MSOT imaging device, side effects, adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR). | — |
Contacts
Public ContactG.M. Dam, van
University Medical Center Groningen Department of Surgery / BioOptical Imaging Center Groningen
Outcome results
None listed