NCT03989583

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 30, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

June 14, 2019

Last Update Submit

June 17, 2019

Conditions

Keywords

ThermographyChildrenFootShoes

Outcome Measures

Primary Outcomes (1)

  • Infrared temperature

    Foot and footwear temperature in children

    march, 30- may, 23 2017

Study Arms (1)

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

Interventions

Temperature observation in foot and footwear in healthy children

Children's feet temperature

Eligibility Criteria

Age9 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Healthy 9- 10 years old children

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Extremadura

Plasencia, Cáceres, 10600, Spain

Location

Related Publications (13)

  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • Čoh M, Širok B. Use of the thermovision method in sport training. Physical Education and Sport. 2007; 5(1): 85-94.

    BACKGROUND
  • Lahiri BB, Bagavathiappan S, Jayakumar T, Philip J. Medical applications of infrared thermography: A review. Infrared Phys Technol. 2012 Jul;55(4):221-235. doi: 10.1016/j.infrared.2012.03.007. Epub 2012 Apr 13.

    PMID: 32288544BACKGROUND
  • Ring E. The historical development of temperature measurement in medicine. Infrared Physics & Technology. 2007; 49(3): 297-301

    BACKGROUND
  • 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.

    BACKGROUND
  • Hildebrandt C, Raschner C, Ammer K. An overview of recent application of medical infrared thermography in sports medicine in Austria. Sensors (Basel). 2010;10(5):4700-15. doi: 10.3390/s100504700. Epub 2010 May 7.

    PMID: 22399901BACKGROUND
  • Mori T, Nagase T, Takehara K, Oe M, Ohashi Y, Amemiya A, Noguchi H, Ueki K, Kadowaki T, Sanada H. Morphological pattern classification system for plantar thermography of patients with diabetes. J Diabetes Sci Technol. 2013 Sep 1;7(5):1102-12. doi: 10.1177/193229681300700502.

    PMID: 24124935BACKGROUND
  • Nagase T, Sanada H, Takehara K, Oe M, Iizaka S, Ohashi Y, Oba M, Kadowaki T, Nakagami G. Variations of plantar thermographic patterns in normal controls and non-ulcer diabetic patients: novel classification using angiosome concept. J Plast Reconstr Aesthet Surg. 2011 Jul;64(7):860-6. doi: 10.1016/j.bjps.2010.12.003. Epub 2011 Jan 22.

    PMID: 21257357BACKGROUND
  • 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.

    BACKGROUND
  • Kolosovas-Machuca ES, Gonzalez FJ. Distribution of skin temperature in Mexican children. Skin Res Technol. 2011 Aug;17(3):326-31. doi: 10.1111/j.1600-0846.2011.00501.x. Epub 2011 Feb 22.

    PMID: 21338404BACKGROUND
  • Ring EF, Ammer K. Infrared thermal imaging in medicine. Physiol Meas. 2012 Mar;33(3):R33-46. doi: 10.1088/0967-3334/33/3/R33. Epub 2012 Feb 28.

    PMID: 22370242BACKGROUND
  • 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

    BACKGROUND

Study Officials

  • Julián F García

    Universidad de Extremadura

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2019

First Posted

June 18, 2019

Study Start

March 30, 2017

Primary Completion

May 23, 2017

Study Completion

May 23, 2017

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations