Rheumatoid ArthritisTG-ARNCT06515769
Use of Thermography for the Prevention and Diagnosis of Rheumatic Foot
An observational study of Rheumatoid Arthritis and Rheumatoid Arthritis RA, run by University of Seville at 1 site in Spain.
Trial summary
The aim of this observational study is to establish normal thermographic parameters in patients with rheumatoid arthritis, in order to prevent and diagnose rheumatic foot using thermography. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Rheumatoid Arthritis RA, Rheumatic Diseases
- What is being tested?
- TERMOGRAPHY
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to 1 Sep 2025
- How long will I take part?
- 6 Months
- 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: Selected patients will be healthy subjects and subjects with more than 5 years of rheumatoid arthritis who wish to voluntarily participate in the study.
Who may be able to join
- Patients with rheumatoid arthritis of more than 5 years\' duration
- Healthy patients without diagnosed systemic disease
- Patients between 40 and 80 years of age
Who cannot join
- Patients who are pregnant or may become pregnant
- Patients with degenerative diseases or significant cognitive impairment
- Patients with rheumatic diseases without a diagnosis of rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
DOCTOR RAQUEL GARCIA DE LA PEÑA RAQUEL, DOCTOR IN HEALTH SCIENCE contact
Spain1 site
University of Seville
Seville, 41008
RAQUEL GARCIA DE LA PEÑA DOCTOR, DOCTOR IN HEALTH SCIENCE, 954-486-5300 ext. +34, raquelgp@us.es
About this study
The aim of this observational study is to establish normal thermographic parameters in patients with rheumatoid arthritis, in order to prevent and diagnose rheumatic foot using thermography. The main question to be answered is: What are the normal thermographic parameters in rheumatic foot?
If there is a comparison group: the researchers will compare the thermography of the foot in healthy subjects and in subjects with rheumatoid arthritis to see if there are any alterations in the thermographic image.
Patients who wish to participate in the study will undergo a thermographic study of the foot, which does not entail any risk to their health.
- Being tested
- TERMOGRAPHY
- Keywords
- Rheumatic foot, Rheumatoid Arthritis, Rheumatic diseases, Thermoghrapy
- Medical subject headings
- Arthritis, Rheumatoid, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TERMOGRAPHYDiagnostic test
Obtaining an image of the foot using a thermographic camera
| Study group | Role | What they receive |
|---|---|---|
| Control group: healthy subjects | Subjects without rheumatoid arthritis or symptoms compatible with this disease Receives: Diagnostic Test: TERMOGRAPHY | |
| Case group: subjects with rheumatoid arthritis | Subjects diagnosed with rheumatoid arthritis Receives: Diagnostic Test: TERMOGRAPHY |
What is being measured
The primary outcome is the main question the study is designed to answer.
NORMAL PARAMETERS IN THERMOGRAPHY IN PATIENS WITH HEALTHY FOOT
Normal parameters of the healthy foot in thermography
Measured: One measurement will be taken at the start of the study and another measurement the following 6 month.
Secondary outcomes (1)
NORMAL PARAMETERS IN TERMOGRAPHY IN PATIENS WITH RHEUMATIC FOOT
Normal parameters in thermography in patients with rheumatic foot
Measured: One measurement will be taken at the start of the study and another measurement the following 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- 200 participants (estimated)
- Target duration
- 6 Months
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515769
- Sponsor's protocol ID
- TERMOGRAPHYAR
- Acronym
- TG-AR
- Status last verified
- Jul 2024
- First submitted
- 24 Jun 2024
- Last updated
- 23 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 23 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 Rheumatic Foot
- ClinicalTrials.gov ID
- NCT06515769
- Acronym / sponsor ID
- TG-AR / TERMOGRAPHYAR
- Keywords
- Rheumatic foot, Rheumatoid Arthritis, Rheumatic diseases, Thermoghrapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 23 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.
The aim of this observational study is to establish normal thermographic parameters in patients with rheumatoid arthritis, in order to prevent and diagnose rheumatic foot using thermography. The main question to be answered is: What are the normal thermographic parameters in rheumatic foot?
If there is a comparison group: the researchers will compare the thermography of the foot in healthy subjects and in subjects with rheumatoid arthritis to see if there are any alterations in the thermographic image.
Patients who wish to participate in the study will undergo a thermographic study of the foot, which does not entail any risk to their health.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: healthy subjects | – | Diagnostic Test: TERMOGRAPHYSubjects without rheumatoid arthritis or symptoms compatible with this disease |
| Case group: subjects with rheumatoid arthritis | – | Diagnostic Test: TERMOGRAPHYSubjects diagnosed with rheumatoid arthritis |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Selected patients will be healthy subjects and subjects with more than 5 years of rheumatoid arthritis who wish to voluntarily participate in the study.
Key inclusion criteria (3 listed)
- Patients with rheumatoid arthritis of more than 5 years\' duration
- Healthy patients without diagnosed systemic disease
- Patients between 40 and 80 years of age
Key exclusion criteria (3 listed)
- Patients who are pregnant or may become pregnant
- Patients with degenerative diseases or significant cognitive impairment
- Patients with rheumatic diseases without a diagnosis of rheumatoid arthritis
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 |
|---|---|---|
| TERMOGRAPHYObtaining an image of the foot using a thermographic camera | Diagnostic test | Case group: subjects with rheumatoid arthritis, Control group: healthy subjects |
Primary outcome
NORMAL PARAMETERS IN THERMOGRAPHY IN PATIENS WITH HEALTHY FOOT
Time frame: One measurement will be taken at the start of the study and another measurement the following 6 month.
Normal parameters of the healthy foot in thermography
1 secondary outcome
NORMAL PARAMETERS IN TERMOGRAPHY IN PATIENS WITH RHEUMATIC FOOT
Time frame: One measurement will be taken at the start of the study and another measurement the following 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 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.
DOCTOR RAQUEL GARCIA DE LA PEÑA RAQUEL, DOCTOR IN HEALTH SCIENCE contact
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 Rheumatoid Arthritis and Rheumatoid Arthritis RA, 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 3 inclusion and 3 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 23 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 DOCTOR RAQUEL GARCIA DE LA PEÑA RAQUEL, DOCTOR IN HEALTH SCIENCE (9544865300 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?
NORMAL PARAMETERS IN THERMOGRAPHY IN PATIENS WITH HEALTHY FOOT (time frame: One measurement will be taken at the start of the study and another measurement the following 6 month.). 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 23 Jul 2024.