NCT06515769

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

June 24, 2024

Last Update Submit

July 17, 2024

Conditions

Keywords

Rheumatic footRheumatoid ArthritisRheumatic diseasesThermoghrapy

Outcome Measures

Primary Outcomes (1)

  • NORMAL PARAMETERS IN THERMOGRAPHY IN PATIENS WITH HEALTHY FOOT

    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 Outcomes (1)

  • NORMAL PARAMETERS IN TERMOGRAPHY IN PATIENS WITH RHEUMATIC FOOT

    One measurement will be taken at the start of the study and another measurement the following 6 month

Study Arms (2)

Control group: healthy subjects

Subjects without rheumatoid arthritis or symptoms compatible with this disease

Diagnostic Test: TERMOGRAPHY

Case group: subjects with rheumatoid arthritis

Subjects diagnosed with rheumatoid arthritis

Diagnostic Test: TERMOGRAPHY

Interventions

TERMOGRAPHYDIAGNOSTIC_TEST

Obtaining an image of the foot using a thermographic camera

Case group: subjects with rheumatoid arthritisControl group: healthy subjects

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Seville

Seville, 41008, Spain

Location

MeSH Terms

Conditions

Arthritis, RheumatoidRheumatic Diseases

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

DOCTOR RAQUEL GARCIA DE LA PEÑA RAQUEL, DOCTOR IN HEALTH SCIENCE

CONTACT

RAQUEL GARCIA DE LA PEÑA, DOCTOR IN HEALTH SCIENCE

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2024

First Posted

July 23, 2024

Study Start

September 1, 2024

Primary Completion

January 1, 2025

Study Completion

September 1, 2025

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations