Diabetic FootNCT06485362
Use of Thermography for the Prevention and Diagnosis of Diabetic Foot
An observational study of Diabetic Foot and Diabetic Neuropathies, run by University of Seville at 1 site in Spain.
Trial summary
Diabetic foot is a serious complication of diabetes mellitus that can lead to ulcerations, infections and, in extreme cases, amputations. Early detection of changes in skin temperature can help prevent these complications. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot, Diabetic Neuropathies, Diabetic Angiopathy
- What is being tested?
- Termography
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to 1 Sep 2026
- How long will I take part?
- 1 Year
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects or those with type 2 diabetes mellitus for more than 5 years who wish to participate in the study voluntarily, who will undergo a thermography of both feet.
Who may be able to join
- Subjects of both sexes. Age between 40 and 80 years. Diagnosis of type 1 or type 2 diabetes mellitus (for the case group). Absence of acute inflammatory diseases in the control group. Signed informed consent.
Who cannot join
- Skin diseases that affect the interpretation of thermography. Recent treatment with medications that affect peripheral circulation. History of lower limb amputation.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Seville
Seville, 41008
RAQUEL GARCIA DE LA PEÑA, DOCTOR, 954486530 ext. +34, raquelgp@us.es
ANA M RAYO PÉREZ, DOCTOR, 661604278 ext. +34, anarayo43@gmail.com
About this study
Diabetic foot is a serious complication of diabetes mellitus that can lead to ulcerations, infections and, in extreme cases, amputations. Early detection of changes in skin temperature can help prevent these complications. Infrared thermography is a noninvasive technique that allows the visualization and quantification of skin temperature and could be an effective tool for the early detection of alterations in diabetic foot.
Objective
To evaluate the effectiveness of infrared thermography in the early detection and diagnosis of diabetic foot, comparing the temperatures of the feet of healthy subjects and subjects with diabetic foot.
Read the detailed description
Significant differences in foot temperatures are expected to be found between subjects with diabetic foot and healthy subjects. It is anticipated that areas of the foot at higher risk of ulceration in subjects with diabetic foot will show higher temperatures due to inflammation and changes in blood perfusion.
The results of the study could validate the use of thermography as an early detection and monitoring tool in patients at risk of developing diabetic foot. This could allow early and personalized interventions to prevent serious complications.
- Conditions
- Diabetic Foot, Diabetic Neuropathies, Diabetic Angiopathy
- Being tested
- Termography
- Keywords
- diabetic foot, neuropaty, angiopaty, termography
- Medical subject headings
- Diabetic Foot, Diabetic Neuropathies, Diabetic Angiopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TermographyDiagnostic test
Thermographic images of both feet will be taken in multiple views (dorsal, plantar, lateral).
| Study group | Role | What they receive |
|---|---|---|
| healthy patients | Subjects healthy will rest barefoot for 15 minutes in a room at constant temperature (22-24°C).
Thermographic images of both feet will be taken in multiple views (dorsal, plantar, lateral).
Images will be analyzed to identify temperature differences between different areas of the foot and between study groups. Receives: Diagnostic Test: Termography | |
| diabetic foot patients | Subjects with diabetic foot, diagnosed with diabetes mellitus for more than 5 years, will rest barefoot for 15 minutes in a room at a constant temperature (22-24°C).
Thermographic images of both feet will be taken in multiple views (dorsal, plantar, lateral).
The images will be analyzed to identify temperature differences between different areas of the foot and between the study groups. Receives: Diagnostic Test: Termography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature maximun
Maximum foot temperatures
Measured: One measurement will be taken at the start of the study and another measurement the following year.
Temperature minimum
Minimum foot temperatures
Measured: One measurement will be taken at the start of the study and another measurement the following year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANA MARIA RAYO PEREZ, University of Seville
- Investigators
- RAQUEL GARCIA DE LA PEÑA, DOCTOR, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485362
- Sponsor's protocol ID
- TERMOGRAPGY-DIABETICFOOT
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Thermography for the Prevention and Diagnosis of Diabetic Foot
- ClinicalTrials.gov ID
- NCT06485362
- Acronym / sponsor ID
- TERMOGRAPGY-DIABETICFOOT
- Conditions
- Diabetic Foot, Diabetic Neuropathies, Diabetic Angiopathy
- Keywords
- diabetic foot, neuropaty, angiopaty, termography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 3 Jul 2024 (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.
Diabetic foot is a serious complication of diabetes mellitus that can lead to ulcerations, infections and, in extreme cases, amputations. Early detection of changes in skin temperature can help prevent these complications. Infrared thermography is a noninvasive technique that allows the visualization and quantification of skin temperature and could be an effective tool for the early detection of alterations in diabetic foot.
Objective
To evaluate the effectiveness of infrared thermography in the early detection and diagnosis of diabetic foot, comparing the temperatures of the feet of healthy subjects and subjects with diabetic foot.
Detailed description
Significant differences in foot temperatures are expected to be found between subjects with diabetic foot and healthy subjects. It is anticipated that areas of the foot at higher risk of ulceration in subjects with diabetic foot will show higher temperatures due to inflammation and changes in blood perfusion.
The results of the study could validate the use of thermography as an early detection and monitoring tool in patients at risk of developing diabetic foot. This could allow early and personalized interventions to prevent serious complications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy patients | – | Diagnostic Test: TermographySubjects healthy will rest barefoot for 15 minutes in a room at constant temperature (22-24°C). Thermographic images of both feet will be taken in multiple views (dorsal, plantar, lateral). Images will be analyzed to identify temperature differences between different areas of the foot and between study groups. |
| diabetic foot patients | – | Diagnostic Test: TermographySubjects with diabetic foot, diagnosed with diabetes mellitus for more than 5 years, will rest barefoot for 15 minutes in a room at a constant temperature (22-24°C). Thermographic images of both feet will be taken in multiple views (dorsal, plantar, lateral). The images will be analyzed to identify temperature differences between different areas of the foot and between the study groups. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects or those with type 2 diabetes mellitus for more than 5 years who wish to participate in the study voluntarily, who will undergo a thermography of both feet.
Key inclusion criteria (1 listed)
- Subjects of both sexes. Age between 40 and 80 years. Diagnosis of type 1 or type 2 diabetes mellitus (for the case group). Absence of acute inflammatory diseases in the control group. Signed informed consent.
Key exclusion criteria (1 listed)
- Skin diseases that affect the interpretation of thermography. Recent treatment with medications that affect peripheral circulation. History of lower limb amputation.
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 |
|---|---|---|
| TermographyThermographic images of both feet will be taken in multiple views (dorsal, plantar, lateral). | Diagnostic test | diabetic foot patients, healthy patients |
Primary outcome
Temperature maximun
Time frame: One measurement will be taken at the start of the study and another measurement the following year.
Maximum foot temperatures
Temperature minimum
Time frame: One measurement will be taken at the start of the study and another measurement the following year.
Minimum foot temperatures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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. This study is not recruiting at the moment.
RAQUEL GARCIA DE LA PEÑA, DOCTOR principal investigator
University of Seville
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 Diabetic Foot and Diabetic Neuropathies, run by University of Seville at 1 site in Spain.
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: status not confirmed, as of the sponsor's last update on 3 Jul 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 Spain. 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 RAQUEL GARCIA DE LA PEÑA, DOCTOR (954486530 ext. +34, raquelgp@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature maximun (time frame: One measurement will be taken at the start of the study and another measurement the following year.). 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 3 Jul 2024.