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

NCT05786001 | Recruiting

• 1 other identifier: R20156L
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Limb Threatening Ischemia

Keywords

hyperspectral imaging; thermal imaging; angiosomes; CLTI; diabetes

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Unhealthy group

Individuals with CLTI

Age control group

Healthy individuals over the age of 50

Healthy group

Healthy and young individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

• inability to give informed consent
• denial

Sponsors & Collaborators

• Tampere University: lead
• Tampere University Hospital: collaborator

Study Sites (1)

Tampere University

Tampere, Pirkanmaa, 33720, Finland

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Niku Oksala, MD, PhD, DSc

  Tampere University, Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niku Oksala, MD, PhD, DSc

CONTACT

+358 331 1611; niku.oksala@tuni.fi

Antti Vehkaoja, DSc

CONTACT

+358 294 5211; antti.vehkaoja@tuni.fi

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof, MD, PhD, DSc

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 27, 2023
• Study Start: June 17, 2024
• Primary Completion: July 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

FI (1)