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Children´s Foot and Footwear Temperatures

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ClinicalTrials.gov Identifier: NCT03989583
Recruitment Status : Completed
First Posted : June 18, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Marina Fontán- Jiménez, Universidad de Extremadura

Brief Summary:
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.

Condition or disease Intervention/treatment
Thermography Other: Infrared thermography

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 162 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Thermographic Analysis of Foot and Footwear in Children
Actual Study Start Date : March 30, 2017
Actual Primary Completion Date : May 23, 2017
Actual Study Completion Date : May 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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




Primary Outcome Measures :
  1. Infrared temperature [ Time Frame: march, 30- may, 23 2017 ]
    Foot and footwear temperature in children



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989583


Locations
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Spain
Universidad de Extremadura
Plasencia, Cáceres, Spain, 10600
Sponsors and Collaborators
Marina Fontán- Jiménez
Investigators
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Study Director: Julián F García Universidad de Extremadura

Publications:
Fernández-Cuevas I, Marins JC, Gómez-Carmona P, García-Concepción MA, Arnaiz-Lastras J, Sillerro-Quintana M. Reliability and reproducibility of skin temperature of overweight subjects by an infrared thermography software designed for human beings. Thermology International. 2012; 22(3): 130-137
Martínez E, Castillo A, Martínez I, Castellote M. Metodología para la intervención en elementos históricos: el caso de la espadaña del convento de Nuestra Señora de la Consolación (Alcalá de Henares-Madrid-España). Informes de la Construcción. 2013; 65(531): 359-366.
Čoh M, Širok B. Use of the thermovision method in sport training. Physical Education and Sport. 2007; 5(1): 85-94.
Lahiri BB, Bagavathiappan S, Jayakumar T, Philip J. Medical applications of infrared thermography: A review. Infrared Physics & Technology. 2012; 55(4): 221-235
Ring E. The historical development of temperature measurement in medicine. Infrared Physics & Technology. 2007; 49(3): 297-301
NG EYK. A review of thermography as promising non-invasive detection modality for breast tumor. International Journal of Thermal Sciences. 2009; 48(5): 849-859.
Ring EFJ, Jung A, Zuber J, Rutowski P, Kalicki B, Bajwa U. Detecting fever in polish children by infrared thermography. En: 9th International conference of quantitative infrared thermography. Poland, 2008.
International Academy of Clinical Thermology (IACT) [Internet]. Redwood City, USA: IACT [citado 8 enero 2017]. Disponible desde: http://www.iact-org.org/professionals/thermog-guidelines.html

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Responsible Party: Marina Fontán- Jiménez, Principal Investigator, Universidad de Extremadura
ClinicalTrials.gov Identifier: NCT03989583     History of Changes
Other Study ID Numbers: UExtremadura
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marina Fontán- Jiménez, Universidad de Extremadura:
Thermography
Children
Foot
Shoes