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Status unknownNCT05268848Updated Mar 7, 2022

Thermography of the Foot With Plantar Orthosis Liners

An interventional study of Thermographic photo in Foot Orthosis and Temperature, sponsored by Universidad de Extremadura. Status unknown at 1 site in Spain. Open to participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-07.

Sponsored by Universidad de Extremadura · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Foot Orthosis
  • Temperature

Keywords

  • infrared thermography
  • orthopodia
  • thermometry
03

In context

Lead sponsor

Universidad de Extremadura is the lead sponsor of 38 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

young or old people with respect to the age of study smokers or drinkers

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
47 participants (estimated)

Study arms

  • Experimental
    Termography PRE

    Foot thermography before lining test

    Other: Thermographic photo

  • Experimental
    Termography POST

    Foot thermography after wearing 2 types of liner for three hours (one on each foot)

    Other: Thermographic photo

  • Active comparator
    Thermographic comparations

    Thermographic comparations between PRE and POST measurements

    Other: Thermographic photo

Interventions

  • OtherThermographic photo

    Barefoot patient, thermographic photo of the sole of the feet is taken

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: for a month

Secondary outcomes

  1. Foot temperature measurement POST

    Photo after the use of linings inside the shoe

    Time frame: for a month

Other outcomes

  1. 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.

    Time frame: for 3 months

07

Study locations

1 of 1 sites recruiting
  • Elena Escamilla Martínez
    Plasencia, Cáceres 10600, Spain
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05268848
Lead sponsor
Universidad de Extremadura
Responsible party
Elena Escamilla Martinez (Assistant proffesor. Nursing Department., Universidad de Extremadura) — Principal investigator
First posted
Mar 7, 2022
Start date
Dec 23, 2021
Primary completion
Apr 1, 2022 (estimated)
Completion
Sep 30, 2022 (estimated)
Last update
Mar 7, 2022

Study contacts

ELENA ESCAMILLA MARTÍNEZ
Contact
escaelen@unex.es
+34 927257000 ext. 52324
ELENA ESCAMILLA MARTÍNEZ
principal investigator · University of Extremadura

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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