Children´s Foot and Footwear Temperatures

June 17, 2019 updated by: Marina Fontán- Jiménez

Thermographic Analysis of Foot and Footwear in Children

This research aims to find thermal differences in foot in a group of children, detecting the most suitable footwear to acquire optimal foot temperature and taking into account that children in school age usually wear sports shoes instead of school shoes in most dimensions of daily life. It is assumed by general population that sports shoes increase sweating and provide less perspiration apart from biomechanical criteria, so for this reason the investigators are going to examine which thermal pattern offers each variety of footwear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infrared thermal image allows detecting object´s temperature visually in a non-contact way. That makes the technique useful for different applications like in construction/ building, ecology, industry and medicine. Evolution of thermographic equipments makes it more accessible. It is a non- contact, non- invasive technique that helps researchers monitoring body temperature. So that, it is used to investigate ocular, liver, kidney and brain diseases, dental diagnosis, breast cancer detection or even sports injuries.

It is increasing the use of thermographic imaging in podiatry, so the main trials concerned to diabetes mellitus, vascular disorder or dermatological applications.

Nevertheless, there is little known about children´s foot temperature. Main studies are related to core temperature or variations in temperature among different parts of the body of enfants.

In consequence, the investigators found a lack of information related to such a significant topic, not only for podiatrists, but also for population in general.

Study Type

Observational

Enrollment (Actual)

162

Contacts and Locations

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

Study Locations

  • Spain
    • Cáceres
      • Plasencia, Cáceres, Spain, 10600
        • Universidad de Extremadura

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

9 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The thermal images were taken from 162 children who were 9- 10 years old in two schools in Mérida (Badajoz), Spain. Their parents or legal guardians were informed and signed an informed consent. All children were taken infrared images, so that skin temperature was evaluated, by dividing the thermograms in regions of interest in dorsal and plantar images of each foot. Shoes were divided into two regions of interest. The measures were taken in two different days: the first day, children wore school footwear and the second sports shoes.

Description

Inclusion Criteria:

  • Healthy 9- 10 years old children

Exclusion Criteria:

  • Vascular disease or another pathology that could interfere with thermal pattern of foot
  • Wore sports shoes daily
  • Used any kind of plantar orthoses, heels…
  • Didn´t have correctly singed informed consent
  • Wore sandals
  • Had a bandaged feet

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children's feet temperature
The thermal images were taken from 162 children who were 9- 10 years old in two schools in Mérida (Badajoz), Spain. Their parents or legal guardians were informed and signed an informed consent. All children were taken infrared images, so that skin temperature was evaluated, by dividing the thermograms in regions of interest in dorsal and plantar images of each foot. Shoes were divided into two regions of interest. The measures were taken in two different days: the first day, children wore school footwear and the second sports shoes.
Other: Infrared thermography
Temperature observation in foot and footwear in healthy children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infrared temperature
Time Frame: march, 30- may, 23 2017
Foot and footwear temperature in children
march, 30- may, 23 2017

Collaborators and Investigators

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

Sponsor

Marina Fontán- Jiménez

Investigators

  • Study Director: Julián F García, Universidad de Extremadura

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 30, 2017

Primary Completion (Actual)

May 23, 2017

Study Completion (Actual)

May 23, 2017

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

June 14, 2019

First Posted (Actual)

June 18, 2019

Study Record Updates

Last Update Posted (Actual)

June 19, 2019

Last Update Submitted That Met QC Criteria

June 17, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UExtremadura

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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