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

Sponsor

Tampere University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05786001

Collaborator

Tampere University Hospital (Other)

150

Enrollment

Location

10.1

Anticipated Duration (Months)

14.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Limb Threatening Ischemia

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Unhealthy group Individuals with CLTI
Age control group Healthy individuals over the age of 50
Healthy group Healthy and young individuals

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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