Chronic Ulcer of SkinR22108LNCT05931081
Thermal Imaging in Diagnostics of Chronic Ulcers and in Monitoring Healing of Chronic Ulcers
An observational study of Chronic Ulcer of Skin, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Patients with chronic ulcer needing tertiary care referred to the Wound Center of Tampere University Hospital are invited to this study. Patients are treated according to standard treatment practices. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Ulcer of Skin
- What is being tested?
- Thermal imaging in diagnostics of chronic ulcers
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- 1 Mar 2023to 31 Dec 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic ulcer i.e. venous, arterial or mixed ulcers or atypical (vasculitic or pyoderma gangraenosum) ulcers needing tertiary care referred to the Wound Center of Tampere University Hospital are invited to this study.
Who may be able to join
- Patients with chronic ulcer i.e. venous, arterial or mixed ulcers or atypical (vasculitic or pyoderma gangraenosum) ulcers needing tertiary care referred to the Wound Center of Tampere University Hospital are invited to this study.
Who cannot join
- Patients with more than one wound etiology in the examined wound (except mixed ulcer) are excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Patients with chronic ulcer needing tertiary care referred to the Wound Center of Tampere University Hospital are invited to this study. Patients are treated according to standard treatment practices. The temperature of the lower limbs and ulcer area is measured during visits using the Thermidas Remote thermal imaging system, a CE-marked medical device for measuring and monitoring changes in skin surface temperature non-invasively. The measured temperatures and differences are compared in different ulcer aetiology groups and analyzed whether thermal imaging can be used to distinguish atypical ulcers from vascular ulcers.
Thermal imaging measurements and clinical examinations are repeated to the patients with atypical ulcers during follow-up visits. Monitoring of ulcers will continue until the ulcer has epithelized completely or for up to a year.
Read the detailed description
4A: Patients with chronic ulcer i.e. venous, arterial or mixed ulcers or atypical (vasculitic or pyoderma gangraenosum) ulcers needing tertiary care referred to the Wound Center of Tampere University Hospital are invited to this study. Aim is to recruit about 20 patients of each group of ulcers. Patients are treated according to standard treatment practices. The temperature of the lower limbs and ulcer area is measured during visits in a standardized measuring environment from both limbs using the Thermidas Remote thermal imaging system (ThRemote 1.3.1, Remote SW with FLIR Inc's series T IR cameras, Thermidas Oy), a CE-marked medical device for measuring and monitoring changes in skin surface temperature non-invasively. The temperature of the ulcer area is compared with the temperature of the corresponding skin area of the other limb and the temperature difference (delta) of the areas is determined. The measured temperatures and differences are compared in different ulcer aetiology groups and analyzed whether thermal imaging can be used to distinguish atypical ulcers from vascular ulcers.
4B: Thermal imaging measurements and clinical examinations are repeated to the patients with atypical ulcers during follow-up visits, and the change in the measurement of temperatures with thermal imaging is compared with the clinician's assessment of the ulcer status (size, ulcer's border activity, necrosis, and pain intensity) and its changes during follow-up visits. Monitoring of ulcers will continue until the ulcer has epithelized completely or for up to a year.
Actual sample size calculations cannot be made, because previous studies on thermal imaging in patients with atypical ulcers have not been published. Based on previous studies, it can be assumed, that statistically significant differences will be obtained between the study groups of approximately 20 subjects. This is a pilot study, and if the study gives promising results, further research will be carried out in the future with more extensive data.
Clinical implication: If thermal imaging is useful in assessing the tendency of ulcer healing, it can be used to optimize the treatment of ulcer patient, such as considering the timing immunosuppressive treatment or skin graft surgery.
- Conditions
- Chronic Ulcer of Skin
- Being tested
- Thermal imaging in diagnostics of chronic ulcers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal imaging in diagnostics of chronic ulcersDevice
Also called venous, arterial or mixed ulcers or atypical ulcers
atypical: vasculitic or pyoderma gangraenosum ulcers
What is being measured
The primary outcome is the main question the study is designed to answer.
temperature difference
difference of skin temperature between region of an ulcer and healthy skin
Measured: 1-12 months
Secondary outcomes (1)
healing of an ulcer
at least 90% epitelized ulcer
Measured: 1-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Mar 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ulcer of SkinStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teija Kimpimäki, Ph.D, Principal investigator, Tampere University Hospital, University of Tampere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931081
- Sponsor's protocol ID
- R22108L
- Acronym
- R22108L
- Status last verified
- Sep 2024
- First submitted
- 23 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Imaging in Diagnostics of Chronic Ulcers and in Monitoring Healing of Chronic Ulcers
- ClinicalTrials.gov ID
- NCT05931081
- Acronym / sponsor ID
- R22108L / R22108L
- Conditions
- Chronic Ulcer of Skin
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Jul 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.
Patients with chronic ulcer needing tertiary care referred to the Wound Center of Tampere University Hospital are invited to this study. Patients are treated according to standard treatment practices. The temperature of the lower limbs and ulcer area is measured during visits using the Thermidas Remote thermal imaging system, a CE-marked medical device for measuring and monitoring changes in skin surface temperature non-invasively. The measured temperatures and differences are compared in different ulcer aetiology groups and analyzed whether thermal imaging can be used to distinguish atypical ulcers from vascular ulcers.
Thermal imaging measurements and clinical examinations are repeated to the patients with atypical ulcers during follow-up visits. Monitoring of ulcers will continue until the ulcer has epithelized completely or for up to a year.
Detailed description
4A: Patients with chronic ulcer i.e. venous, arterial or mixed ulcers or atypical (vasculitic or pyoderma gangraenosum) ulcers needing tertiary care referred to the Wound Center of Tampere University Hospital are invited to this study. Aim is to recruit about 20 patients of each group of ulcers. Patients are treated according to standard treatment practices. The temperature of the lower limbs and ulcer area is measured during visits in a standardized measuring environment from both limbs using the Thermidas Remote thermal imaging system (ThRemote 1.3.1, Remote SW with FLIR Inc's series T IR cameras, Thermidas Oy), a CE-marked medical device for measuring and monitoring changes in skin surface temperature non-invasively. The temperature of the ulcer area is compared with the temperature of the corresponding skin area of the other limb and the temperature difference (delta) of the areas is determined. The measured temperatures and differences are compared in different ulcer aetiology groups and analyzed whether thermal imaging can be used to distinguish atypical ulcers from vascular ulcers.
4B: Thermal imaging measurements and clinical examinations are repeated to the patients with atypical ulcers during follow-up visits, and the change in the measurement of temperatures with thermal imaging is compared with the clinician's assessment of the ulcer status (size, ulcer's border activity, necrosis, and pain intensity) and its changes during follow-up visits. Monitoring of ulcers will continue until the ulcer has epithelized completely or for up to a year.
Actual sample size calculations cannot be made, because previous studies on thermal imaging in patients with atypical ulcers have not been published. Based on previous studies, it can be assumed, that statistically significant differences will be obtained between the study groups of approximately 20 subjects. This is a pilot study, and if the study gives promising results, further research will be carried out in the future with more extensive data.
Clinical implication: If thermal imaging is useful in assessing the tendency of ulcer healing, it can be used to optimize the treatment of ulcer patient, such as considering the timing immunosuppressive treatment or skin graft surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic ulcer i.e. venous, arterial or mixed ulcers or atypical (vasculitic or pyoderma gangraenosum) ulcers needing tertiary care referred to the Wound Center of Tampere University Hospital are invited to this study.
Key inclusion criteria (1 listed)
- Patients with chronic ulcer i.e. venous, arterial or mixed ulcers or atypical (vasculitic or pyoderma gangraenosum) ulcers needing tertiary care referred to the Wound Center of Tampere University Hospital are invited to this study.
Key exclusion criteria (1 listed)
- Patients with more than one wound etiology in the examined wound (except mixed ulcer) are excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal imaging in diagnostics of chronic ulcersAlso: venous, arterial or mixed ulcers or atypical ulcersatypical: vasculitic or pyoderma gangraenosum ulcers | Device | – |
Primary outcome
temperature difference
Time frame: 1-12 months
difference of skin temperature between region of an ulcer and healthy skin
1 secondary outcome
healing of an ulcer
Time frame: 1-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Teija Kimpimäki, Ph.D principal investigator
Tampere University Hospital, University of Tampere
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 Ulcer of Skin, run by Tampere University Hospital 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 19 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
temperature difference (time frame: 1-12 months). 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 19 Sep 2024.