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ThermographyNCT03989583

Children´s Foot and Footwear Temperatures

An observational study of Thermography, run by Marina Fontán- Jiménez at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 9 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Thermography
What is being tested?
Infrared thermography
How many people
162 participants
Where
1 siteSpain
Study dates
30 Mar 2017to 23 May 2017
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

  • Healthy 9- 10 years old children

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad de Extremadura

    Plasencia, Cáceres, 10600

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions
Thermography
Being tested
Infrared thermography
Keywords
Thermography, Children, Foot, Shoes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infrared thermographyOther

    Temperature observation in foot and footwear in healthy children

Study groups in NCT03989583
Study groupRoleWhat they receive
Children's feet temperatureThe 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.
Receives: Other: Infrared thermography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infrared temperature

    Foot and footwear temperature in children

    Measured: march, 30- may, 23 2017

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2019
  2. Study start30 Mar 2017
  3. Primary completion23 May 2017
  4. Study completion23 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
162 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT03989583
Sponsor's protocol ID
UExtremadura
Status last verified
Jun 2019
First submitted
14 Jun 2019
Last updated
19 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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 Phys Technol. 2012 Jul;55(4):221-235. doi: 10.1016/j.infrared.2012.03.007. Epub 2012 Apr 13.

    PubMed 32288544

  • 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.

  • 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.

    PubMed 22399901

  • 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.

    PubMed 24124935

  • 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.

    PubMed 21257357

  • 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.

  • 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.

    PubMed 21338404

  • 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.

    PubMed 22370242

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Thermography, run by Marina Fontán- Jiménez at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infrared temperature (time frame: march, 30- may, 23 2017). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03989583, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.

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