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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03989583
Other study ID # UExtremadura
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 30, 2017
Est. completion date May 23, 2017

Study information

Verified date June 2019
Source Universidad de Extremadura
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 162
Est. completion date May 23, 2017
Est. primary completion date May 23, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 10 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Infrared thermography
Temperature observation in foot and footwear in healthy children

Locations

Country Name City State
Spain Universidad de Extremadura Plasencia Cáceres

Sponsors (1)

Lead Sponsor Collaborator
Marina Fontán- Jiménez

Country where clinical trial is conducted

Spain, 

References & Publications (13)

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

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

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. Review. — View Citation

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

Kolosovas-Machuca ES, González 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. — View Citation

Lahiri BB, Bagavathiappan S, Jayakumar T, Philip J. Medical applications of infrared thermography: A review. Infrared Physics & Technology. 2012; 55(4): 221-235

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.

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. — View Citation

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. — View Citation

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

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. Review. — View Citation

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.

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Infrared temperature Foot and footwear temperature in children march, 30- may, 23 2017
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