Chronic Limb Threatening IschemiaNCT05786001
Multimodal Noninvasive Assessment of Peripheral Circulation in Chronic Limb-threatening Ischemia
An observational study of Chronic Limb Threatening Ischemia, run by Tampere University at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Limb Threatening Ischemia
- How many people
- 150 participants
- Where
- 1 siteFinland
- Study dates
- 17 Jun 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- inability to give informed consent
- denial
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Tampere University
Tampere, Pirkanmaa, 33720
Antti Vehkaoja, DSc, antti.vehkaoja@tuni.fi
Emmi Peltola, MSc, emmi.peltola@tuni.fi
About this study
Official title: 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.
- Conditions
- Chronic Limb Threatening Ischemia
- Keywords
- hyperspectral imaging, thermal imaging, angiosomes, CLTI, diabetes
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unhealthy group | Individuals with CLTI | |
| Age control group | Healthy individuals over the age of 50 | |
| Healthy group | Healthy and young individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 45 minutes during the procedure starting from the first measurement and ending after the last measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start17 Jun 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Limb Threatening IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital
- Responsible party
- Principal investigator, Niku Oksala, Tampere University
- Investigators
- Niku Oksala, MD, PhD, DSc, Principal investigator, Tampere University, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786001
- Sponsor's protocol ID
- R20156L
- Status last verified
- Jun 2024
- First submitted
- 30 Jan 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lower Limb Angiosome Perfusion and Oxygenation Using Thermal and Hyperspectral Imaging
- ClinicalTrials.gov ID
- NCT05786001
- Acronym / sponsor ID
- R20156L
- Conditions
- Chronic Limb Threatening Ischemia
- Keywords
- hyperspectral imaging, thermal imaging, angiosomes, CLTI, diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Tampere University Hospital
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unhealthy group | – | –Individuals with CLTI |
| Age control group | – | –Healthy individuals over the age of 50 |
| Healthy group | – | –Healthy and young individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- inability to give informed consent
- denial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niku Oksala, MD, PhD, DSc principal investigator
Tampere University, Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Limb Threatening Ischemia, run by Tampere University at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niku Oksala, MD, PhD, DSc (+358 331 1611, niku.oksala@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.