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NCT05268848 Clinical Trial

Thermography of the Foot With Plantar Orthosis Liners

Temperature Clinical Trial

Official title:
Foot Thermography With the Use of Different Plantar Orthosis Lining Materials

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05268848
Other study ID # Termografiaforros2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 23, 2021
Est. completion date September 30, 2022

Study information
Verified date February 2022
Source Universidad de Extremadura
Contact ELENA ESCAMILLA MARTÍNEZ
Phone +34 927257000
Email escaelen@unex.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objetive: To analyze the thermal effects of the types of liners used in the manufacture of the foot orthoses, as well as to establish the thermal differences among them. Design: Quantitative, experimental, longitudinal and prospective study. Subjects: 47 individuals selected randomly, over 20 years of age Methods: 4 types of liner were studied: natural skin, synthetic leather, perforated E.V.A and E.V.A. without perforation.

Recruitment information / eligibility
Status Recruiting
Enrollment 47
Est. completion date September 30, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: People wearing sanitary footwear. 20-35 years Not having smoked or taken alcohol or exciting drinks before evaluation Without cream on the sking and not being exposed to UV rays. Exclusion Criteria: young or old people with respect to the age of study smokers or drinkers

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Thermographic photo
Barefoot patient, thermographic photo of the sole of the feet is taken

Locations
Country Name City State
Spain Elena Escamilla Martínez Plasencia Cáceres

Sponsors (1)
Lead Sponsor Collaborator
Universidad de Extremadura

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Other Foot temperature measurment by area Using the Flir Tools software, 3 areas were selected on each foot, calculating the average temperature in each area: metatarsal heads, lateral region and heel center. for 3 months
Primary Foot temperature measurement PRE The camera Flir E60BX was used, placed on a tripod one meter away from the feet. A photo of the sole of the foot was taken. for a month
Secondary Foot temperature measurement POST Photo after the use of linings inside the shoe for a month
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