Thermography of the Foot With Plantar Orthosis Liners

• Sponsor: Universidad de Extremadura (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05268848
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 9.2
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Foot Orthosis; Temperature	Other: Thermographic photo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Foot Thermography With the Use of Different Plantar Orthosis Lining Materials
• Actual Study Start Date: Dec 23, 2021
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Foot temperature measurement PRE [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.

Secondary Outcome Measures

1. Foot temperature measurement POST [for a month]

   Photo after the use of linings inside the shoe

Other Outcome Measures

1. Foot temperature measurment by area [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Elena Escamilla Martínez	Plasencia	Cáceres	Spain	10600

Sponsors and Collaborators

• Universidad de Extremadura

Investigators

• Principal Investigator: ELENA ESCAMILLA MARTÍNEZ, University of Extremadura

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elena Escamilla Martinez, Assistant proffesor. Nursing Department., Universidad de Extremadura
• ClinicalTrials.gov Identifier: NCT05268848
• Other Study ID Numbers: Termografiaforros2022
• First Posted: Mar 7, 2022
• Last Update Posted: Mar 7, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Elena Escamilla Martinez, Assistant proffesor. Nursing Department., Universidad de Extremadura: infrared thermography; orthopodia; thermometry

Study Results

No Results Posted as of Mar 7, 2022