Pilot study of non-invasive tissue perfusion imaging in Peripheral Arterial Disease with MultiSpectral Optoacoustic Tomography

Conditions: Peripheral arterial disease. Diabetes mellitus. Ulceration

Registration Number: NL-OMON24597

Lead Sponsor: niversity Medical Center Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

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

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
?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.<br>?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.<br>?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.