on-invasive imaging of perfusion and oxygenation of the LOWer extremities in healthy volunteers by means of Multispectral Optoacoustic Tomography (LOW-MSOT)
- Conditions
- perfusion and oxygenation of the lower legs100283021004704310003216
- Registration Number
- NL-OMON38860
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
- Healthy volunteers.
- No prior or current medication.
- Age >= 18 years.
- Written informed consent.
- Adequate potential for telephone follow-up 14 days following the measurement with MSOT.
- 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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Determination of the measurement variation (mean and SD) of MSOT in<br /><br>physiological conditions of the lower leg. correlation of MSOT oxygenation and<br /><br>perfusion measurements with pulse oximetry of the hallux.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To obtain information on safety aspects of the MSOT imaging device, side<br /><br>effects, adverse events (AE), serious adverse events (SAE) and suspected<br /><br>unexpected serious adverse reactions (SUSAR). </p><br>