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Clinical Trials/NCT05786001
NCT05786001
Recruiting
N/A

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

Tampere University1 site in 1 country150 target enrollmentJune 17, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Limb Threatening Ischemia
Sponsor
Tampere University
Enrollment
150
Locations
1
Primary Endpoint
Perfusion in lower limb angiosomes assessed by thermal imaging
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 17, 2024
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Niku Oksala

Prof, MD, PhD, DSc

Tampere University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Perfusion in lower limb angiosomes assessed by thermal imaging

Time Frame: 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.

Time Frame: 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.

Study Sites (1)

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