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

Chronic Limb Threatening Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786001
• Other study ID #: R20156L
• Status: Recruiting
• Start date: June 17, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Tampere University
• Contact: Niku Oksala, MD, PhD, DSc
• Phone: +358 331 1611
• Email: niku.oksala[@]tuni.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Limb Threatening Ischemia
• Chronic Limb-Threatening Ischemia
• Ischemia

Locations

Country	Name	City	State
Finland	Tampere University	Tampere	Pirkanmaa

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University	Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	45 minutes during the procedure starting from the first measurement and ending after the last measurement
Primary	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.	45 minutes during the procedure starting from the first measurement and ending after the last measurement