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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49494

Enrollment

Registered

2020-07-27

Start date

2022-02-01

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Peripheral arterial disease - Constricted bloodflow to the legs

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The main endpoint is the visualization and quantification of oxygenated and deoxygenated haemoglobin, in healthy volunteers, claudicants and patients with limb-threatening limb ischemia.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results