Clinical trial NCT03989583: Children´s Foot and Footwear Temperatures
Official title: Thermographic Analysis of Foot and Footwear in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thermography
Keywords: Thermography
Children
Foot
Shoes
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 162
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Infrared temperature
timeFrame: march, 30- may, 23 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Plasencia
country: Spain
facility: Universidad de Extremadura
state: Cáceres
Study officials:
affiliation: Universidad de Extremadura
name: Julián F García
role: STUDY_DIRECTOR
References:
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