Multimodal Noninvasive Assessment of Peripheral Circulation in Chronic Limb-threatening Ischemia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTampere University

About this trial

Assessment of a novel diagnostic method for screening and diagnosing chronic limb-threatening ischemia (CLTI). Using hyperspectral and thermal imaging, the perfusion and oxygenation in the lower limbs will be studied in healthy and unhealthy individuals.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

for CLTI patients age >50

for age control group age >50 and not diagnosed with cardiovascular diseases. 0.9 < ABI < 1.3

for healthy group 18 <= age <= 50 and no history of cardiovascular disease

volunteering for study

Disqualifiers

inability to give informed consent

denial

Trial population

* patients at the Vascular Centre Polyclinic and Vascular Surgery Ward at Tampere University Hospital * Orthopaedic patients, joint replacement hospital and orthopaedic ward at Tampere University Hospital * students and staff from Tampere University and Tampere University Hospital

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 3 trial groups
Group A: Unhealthy group
Group B: Age control group
Group C: Healthy group

Trial outcomes

Primary outcomes

1

Perfusion in lower limb angiosomes assessed by thermal imaging

Thermal imaging will be used to assess the perfusion in the lower limbs. The lower limb can be divided into six angiosomes, which can then be used to assess thermal patterns. Healthy and unhealthy feet will present with different thermal patterns and other changes in thermographs.

Time frame
45 minutes during the procedure starting from the first measurement and ending after the last measurement
2

Oxygenation in lower limb angiosomes assessed by hyperspectral imaging.

Hyperspectral imaging can be used in the assessment of oxygenation in the lower limb angiosomes. Based on hyperspectral imaging, oxygenation maps can be generated and then analyzed. Differences between the oxygenation maps of healthy and unhealthy patients will be established.

Time frame
45 minutes during the procedure starting from the first measurement and ending after the last measurement

Secondary outcomes

Other outcomes

Sponsors and contacts

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Tampere University

Lead sponsor

Tampere University Hospital

Collaborator