Thermography of the Foot With Plantar Orthosis Liners

February 24, 2022 updated by: Elena Escamilla Martinez, Universidad de Extremadura

Foot Thermography With the Use of Different Plantar Orthosis Lining Materials

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: ELENA ESCAMILLA MARTÍNEZ
  • Phone Number: 52324 +34 927257000
  • Email: escaelen@unex.es

Study Locations

  • Spain
    • Cáceres
      • Plasencia, Cáceres, Spain, 10600
        • Recruiting
        • Elena Escamilla Martínez
        • Contact:
          • ELENA ESCAMILLA MARTÍNEZ
          • Phone Number: 52324 +34 927257000
          • Email: escaelen@unex.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Termography PRE
Foot thermography before lining test
Other: Thermographic photo
Barefoot patient, thermographic photo of the sole of the feet is taken
Experimental: Termography POST
Foot thermography after wearing 2 types of liner for three hours (one on each foot)
Other: Thermographic photo
Barefoot patient, thermographic photo of the sole of the feet is taken
Active Comparator: Thermographic comparations
Thermographic comparations between PRE and POST measurements
Other: Thermographic photo
Barefoot patient, thermographic photo of the sole of the feet is taken

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot temperature measurement PRE
Time Frame: for a month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot temperature measurement POST
Time Frame: for a month
Photo after the use of linings inside the shoe
for a month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot temperature measurment by area
Time Frame: for 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Extremadura

Investigators

  • Principal Investigator: ELENA ESCAMILLA MARTÍNEZ, University of Extremadura

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

February 24, 2022

First Posted (Actual)

March 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 7, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Termografiaforros2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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