Use of Thermography for the Prevention and Diagnosis of Rheumatic Foot (TG-AR)

July 17, 2024 updated by: ANA MARIA RAYO PEREZ, University of Seville

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: DOCTOR RAQUEL GARCIA DE LA PEÑA RAQUEL, DOCTOR IN HEALTH SCIENCE
  • Phone Number: +34 9544865300
  • Email: raquelgp@us.es

Study Contact Backup

  • Name: RAQUEL GARCIA DE LA PEÑA, DOCTOR IN HEALTH SCIENCE
  • Phone Number: +34 9544865300
  • Email: raquelgp@us.es

Study Locations

  • Spain
      • Seville, Spain, 41008
        • University of Seville
        • Contact:
          • RAQUEL GARCIA DE LA PEÑA DOCTOR, DOCTOR IN HEALTH SCIENCE
          • Phone Number: +34 954-486-5300
          • Email: raquelgp@us.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Patients with rheumatoid arthritis of more than 5 years' duration
  • Healthy patients without diagnosed systemic disease
  • Patients between 40 and 80 years of age

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group: healthy subjects
Subjects without rheumatoid arthritis or symptoms compatible with this disease
Diagnostic test: TERMOGRAPHY
Obtaining an image of the foot using a thermographic camera
Case group: subjects with rheumatoid arthritis
Subjects diagnosed with rheumatoid arthritis
Diagnostic test: TERMOGRAPHY
Obtaining an image of the foot using a thermographic camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One measurement will be taken at the start of the study and another measurement the following 6 month.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Normal parameters in thermography in patients with rheumatic foot
One measurement will be taken at the start of the study and another measurement the following 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TERMOGRAPHYAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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