Thermography of the Foot With Plantar Orthosis Liners
Foot Thermography With the Use of Different Plantar Orthosis Lining Materials
1 other identifier
interventional
47
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2021
Shorter than P25 for not_applicable
1 active site
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
CompletedStudy Start
First participant enrolled
December 23, 2021
CompletedFirst Posted
Study publicly available on registry
March 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedMarch 7, 2022
February 1, 2022
3 months
December 22, 2021
February 24, 2022
Conditions
Keywords
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
EXPERIMENTALFoot thermography before lining test
Termography POST
EXPERIMENTALFoot thermography after wearing 2 types of liner for three hours (one on each foot)
Thermographic comparations
ACTIVE COMPARATORThermographic comparations between PRE and POST measurements
Interventions
Barefoot patient, thermographic photo of the sole of the feet is taken
Eligibility Criteria
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
Study Officials
- PRINCIPAL INVESTIGATOR
ELENA ESCAMILLA MARTÍNEZ
University of Extremadura
Central Study Contacts
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