Skip to content

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24597
Enrollment
30
Registered
2019-10-17
Start date
2020-01-01
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 arterial disease. Diabetes mellitus. Ulceration

Interventions

none

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
? 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. ? 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. ? 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.

Contacts

Public ContactSimone Kleiss

UMCG

s.f.kleiss@umcg.nl0655256492

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)