ClinicalTrials.gg
RecruitingNCT05786001Updated Jun 20, 2024

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

An observational study in Chronic Limb Threatening Ischemia, sponsored by Tampere University. Recruiting at 1 site in Finland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-20.

Sponsored by Tampere University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 4 months later.

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Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Limb Threatening Ischemia

Keywords

  • hyperspectral imaging
  • thermal imaging
  • angiosomes
  • CLTI
  • diabetes
03

In context

Chronic Limb-Threatening Ischemia

357 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 72 are open to participants now.

This study's planned enrollment of 150 is above the median of 111 across 102 observational studies indexed under Chronic Limb-Threatening Ischemia.

Browse Chronic Limb-Threatening Ischemia studies →

Lead sponsor

Tampere University is the lead sponsor of 63 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • inability to give
  • denial
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Unhealthy group

    Individuals with CLTI

  • Age control group

    Healthy individuals over the age of 50

  • Healthy group

    Healthy and young individuals

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 45 minutes during the procedure starting from the first measurement and ending after the last measurement

  2. 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.

    Time frame: 45 minutes during the procedure starting from the first measurement and ending after the last measurement

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2024 (actual). Primary completion is estimated for Jul 2025, 13 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2023
First posted
Mar 27, 2023
StartActual
Jun 17, 2024
Primary completionEst.
Jul 30, 2025
CompletionEst.
Dec 31, 2025
Last update
Jun 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05786001
Lead sponsor
Tampere University
Responsible party
Niku Oksala (Prof, MD, PhD, DSc, Tampere University) — Principal investigator
First posted
Mar 27, 2023
Start date
Jun 17, 2024
Primary completion
Jul 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jun 20, 2024

Study contacts

Niku Oksala, MD, PhD, DSc
Contact
niku.oksala@tuni.fi
+358 331 1611
Antti Vehkaoja, DSc
Contact
antti.vehkaoja@tuni.fi
+358 294 5211
Niku Oksala, MD, PhD, DSc
principal investigator · Tampere University, Tampere University Hospital

Oversight

FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

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