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

Evaluation of Lower Limb Angiosome Perfusion and Oxygenation Using Thermal and Hyperspectral Imaging

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05786001

Enrollment

150

Registered

2023-03-27

Start date

2024-06-17

Completion date

2025-12-31

Last updated

2024-06-20

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

Conditions

Chronic Limb Threatening Ischemia

Keywords

hyperspectral imaging, thermal imaging, angiosomes, CLTI, diabetes

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* inability to give informed consent * denial

Design outcomes

Primary

Measure	Time frame	Description
Perfusion in lower limb angiosomes assessed by thermal imaging	45 minutes during the procedure starting from the first measurement and ending after the last measurement	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.
Oxygenation in lower limb angiosomes assessed by hyperspectral imaging.	45 minutes during the procedure starting from the first measurement and ending after the last measurement	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.

Countries

Finland

Contacts

Primary ContactNiku Oksala, MD, PhD, DSc

niku.oksala@tuni.fi+358 331 1611

Backup ContactAntti Vehkaoja, DSc

antti.vehkaoja@tuni.fi+358 294 5211

Outcome results