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

June 18, 2024 updated by: Niku Oksala, Tampere University

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Unhealthy group
Individuals with CLTI
Age control group
Healthy individuals over the age of 50
Healthy group
Healthy and young individuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
45 minutes during the procedure starting from the first measurement and ending after the last measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University

Collaborators

Tampere University Hospital

Investigators

  • Principal Investigator: Niku Oksala, MD, PhD, DSc, Tampere University, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2024

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R20156L

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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