Peripheral arterial disease. Diabetes mellitus. Ulceration
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: For this study 30 subjects will be included: 10 healthy volunteers, 10 claudicants or patients with non-critical limb ischemia (Rutherford 2-3) and 10 patients with critical limb-threatening ischemia (Rutherford 4-6). All subjects have to be older than 18 years.
Exclusion criteria
Exclusion criteria: Healthy volunteers: - Symptoms or history of peripheral vascular disease - Symptoms or history of peripheral neuropathy For 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 - Severe peripheral pitting oedema. - Severe cardiac-pulmonary failure. - Active cellulitis-erysipelas of the legs or other dermatological diseases. - (Partial) amputation of one of the feet and/or legs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective is to quantify tissue saturation by resolving oxygenated and deoxygenated haemoglobin in healthy volunteers, claudicants and patients with critical limb threatening ischemia. | — |
Secondary
| Measure | Time frame |
|---|---|
| ? To develop a standardized and optimized measurement protocol for MSOT imaging in the lower extremity, including most adequate location on the lower leg in order to optimize precision and accuracy of measurements. ? To evaluate tissue saturation determined with MSOT in reference to standard diagnostics such as ankle/brachial index (ABI), toe systolic blood pressure (TBP), Doppler ultrasound and TcPO2 measurements. ? To visualize the affected arteries and to determine tissue perfusion values before and after supervised exercise in claudicants or revascularization procedures in patients with critical limb-threatening ischemia. | — |
Contacts
UMCG