peripheral vascular disease
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years. - Written informed consent. - Peripheral Vascular Disease Fontaine Classification stages II, III, or IV.
Exclusion criteria
Exclusion criteria: - Medical or psychiatric conditions that compromise the patient*s ability to give informed consent. - Surgical treatment for skin abnormalities (e.g. removal of skin, skin transplants) and/or tattooing on the imaging landmarks. - Active auto-immune vascular diseases. - Lower leg fractures within the past 12 months. - Pregnancy or breast feeding. - (Partial) amputation of one of the legs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objectives To investigate the feasibility and clinical performance of MSOT imaging of the feet in PVD patients. Research aims to assess primary objective 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: Microvascular parameters - Quantification of total amount of HbO2 per volume at landmarks Large artery parameters - Hemoglobin oxygen saturation - Morphology (normal/plaque) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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*AGE reader device) and pulse oximetry of the toes. Research aims to assess secondary objectives - To correlate pathological changes on MSOT images with Fontaine classification. - To correlate pathological changes on MSOT images with lower ABI ( | — |
Countries
Netherlands
Outcome results
None listed