on-invasive imaging of Peripheral Vascular Disease with MultiSpectral Optoacoustic Tomography (PVD-MSOT).
- Conditions
- Peripheral vascular disease, MSOT, atherosclerosis, diabetes mellitus, Fontaine classification, duplex ultrasoundPerifeer vaatlijden, atherosclerose, Fontaine classificatie, echo duplex.
- Registration Number
- NL-OMON20951
- Lead Sponsor
- niversity Medical Center Groningen (UMCG). http://www.umcg.nl
- Brief Summary
/A.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Patients attending the outpatient clinic of the vascular surgey at the Universal Medical Center Groningen.
- Age > 18 years.
- Peripheral Vascular Disease Fontaine Classification stages II, III, or IV.
- Obtained written informed consent.
Exclusion Criteria
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- Previous surgical or radiological treatment (percutaneous procedures with or without stenting) for PVD in the legs.
- Surgical treatment for skin abnormalities (e.g. removal of skin, skin transplants and/or tattooing).
- Active auto-immune vascular diseases.
- Lower leg fractures within the past 12 months.
- Pregnancy or breast feeding.
- (Partial) amputation of one of the legs and/or toes.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The study aims to acquire MSOT images at landmarks of both feet of each included patient. These landmarks correspond to either large arteries (e.g. arteria tibialis posterior) or regions where microvasculature should be assessed (e.g. pads of each toe). The acquired images will then be analyzed to obtain the following parameters:<br><br>Microvascular parameters<br>- Quantification of total amount of HbO2 per volume at landmarks<br><br>Large artery parameters<br>- Hemoglobin oxygen saturation<br>- Morphology (normal/plaque)
- Secondary Outcome Measures
Name Time Method To investigate whether pathological changes can be seen in the MSOT images which correlate with findings in standard diagnostics (e.g. Fontaine classification, ABI, duplex ultrasound) and additional measurements, comprising Advanced Glycation Endproducts (i.e. skin autofluorescence¡ªAGE reader device) and pulse oximetry of the toes.