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

Conditions: Peripheral arterial disease - Constricted bloodflow to the legs
10003216

Registration Number: NL-OMON49494

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Healthy volunteers:
- 18 years and older
- Written informed consent
- Rutherford classification 0
Patients with PAD:
- 18 years and older
- Written informed consent
- Claudicants, Rutherford classification 2 and 3.
- Critical limb ischemia, Rutherford classification 4 to 6.

Exclusion Criteria

Healthy volunteers:
- Investigations or treatment for 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.
- Pregnancy or lactation

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is the visualization and quantification of oxygenated and<br /><br>deoxygenated haemoglobin, in healthy volunteers, claudicants and patients with<br /><br>limb-threatening limb ischemia. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The second endpoint is a standardized measurement protocol for MSOT imaging in<br /><br>the lower extremity in order to optimize precision and accuracy of the<br /><br>measurements. A endpoint is the change in optocoustic signal before, during and<br /><br>after cuff occlusion.Other endpoints are MSOT signal intensity in reference to<br /><br>standard diagnostics such as, ABI, TBP, Doppler wave forms, severity of<br /><br>stenosis on CTA (or MRA), and TcPO2 measurements. Another endpoint is the<br /><br>visualization of the affected arteries and measured difference in oxygenated<br /><br>and deoxygenated haemoglobin before and after treatment in claudicants and<br /><br>patients with critical limb-threatening ischemia.</p><br>