on-invasive imaging of Peripheral Vascular Disease with MultiSpectral Optoacoustic Tomography (PVD-MSOT), a Pilot Study.

Completed

• Conditions: peripheral vascular disease; 10003216

• Registration Number: NL-OMON41212
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

- Age >= 18 years.
- Written informed consent.
- Peripheral Vascular Disease Fontaine Classification stages II, III, or IV.

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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objectives<br /><br>To investigate the feasibility and clinical performance of MSOT imaging of the<br /><br>feet in PVD patients.<br /><br><br /><br>Research aims to assess primary objective<br /><br>The study aims to acquire MSOT images at landmarks of both feet of each<br /><br>included patient. These landmarks correspond to either large arteries (e.g.<br /><br>arteria tibialis posterior) or regions where microvasculature should be<br /><br>assessed (e.g. pads of each toe). The acquired images will then be analyzed to<br /><br>obtain the following parameters:<br /><br><br /><br>Microvascular parameters<br /><br>- Quantification of total amount of HbO2 per volume at landmarks<br /><br><br /><br>Large artery parameters<br /><br>- Hemoglobin oxygen saturation<br /><br>- Morphology (normal/plaque)</p><br>