Non-invasive imaging of Peripheral Vascular Disease with MultiSpectral Optoacoustic Tomography (PVD-MSOT).

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20951

Enrollment

Registered

2014-03-10

Start date

2014-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral vascular disease, MSOT, atherosclerosis, diabetes mellitus, Fontaine classification, duplex ultrasound Perifeer vaatlijden, atherosclerose, Fontaine classificatie, echo duplex.

Interventions

- MSOT imaging of the microvasculature will be performed on both feet at the arteriae tibialis posterior and dorsalis pedis, the medial side of the hallux, and plantar distal side of the phalanges. -

Eligibility

Inclusion criteria

Inclusion criteria: - Patients attending the outpatient clinic of the vascular surgey at the Universal Medical Center Groningen. - Age > 18 years. - Peripheral Vascular Disease Fontaine Classification stages II, III, or IV. - Obtained written informed consent.

Exclusion criteria

Exclusion criteria: - Medical or psychiatric conditions that compromise the patient's ability to give informed consent. - Previous surgical or radiological treatment (percutaneous procedures with or without stenting) for PVD in the legs. - Surgical treatment for skin abnormalities (e.g. removal of skin, skin transplants and/or tattooing). - Active auto-immune vascular diseases. - Lower leg fractures within the past 12 months. - Pregnancy or breast feeding. - (Partial) amputation of one of the legs and/or toes.

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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¡ªAGE reader device) and pulse oximetry of the toes.	—

Contacts

Public ContactC.J.A.M. Zeebregts

University Medical Center Groningen Hanzeplein 1

c.j.a.m.zeebregts@umcg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)