NCT05268848

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

December 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

March 7, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

December 22, 2021

Last Update Submit

February 24, 2022

Conditions

Keywords

infrared thermographyorthopodiathermometry

Outcome Measures

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.

    for a month

Secondary Outcomes (1)

  • Foot temperature measurement POST

    for a month

Other Outcomes (1)

  • Foot temperature measurment by area

    for 3 months

Study Arms (3)

Termography PRE

EXPERIMENTAL

Foot thermography before lining test

Other: Thermographic photo

Termography POST

EXPERIMENTAL

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

Other: Thermographic photo

Thermographic comparations

ACTIVE COMPARATOR

Thermographic comparations between PRE and POST measurements

Other: Thermographic photo

Interventions

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

Termography POSTTermography PREThermographic comparations

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elena Escamilla Martínez

Plasencia, Cáceres, 10600, Spain

RECRUITING

Study Officials

  • ELENA ESCAMILLA MARTÍNEZ

    University of Extremadura

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ELENA ESCAMILLA MARTÍNEZ

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant proffesor. Nursing Department.

Study Record Dates

First Submitted

December 22, 2021

First Posted

March 7, 2022

Study Start

December 23, 2021

Primary Completion

April 1, 2022

Study Completion

September 30, 2022

Last Updated

March 7, 2022

Record last verified: 2022-02

Locations