Foot OrthosisNCT05268848
Thermography of the Foot With Plantar Orthosis Liners
A study testing Thermographic photo in people with Foot Orthosis and Temperature, run by Universidad de Extremadura at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Foot Orthosis, Temperature
- What is being tested?
- Thermographic photo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSpain
- Study dates
- 23 Dec 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- young or old people with respect to the age of study smokers or drinkers
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Elena Escamilla Martínez
Plasencia, Cáceres, 10600
ELENA ESCAMILLA MARTÍNEZ, +34 927257000 ext. 52324, escaelen@unex.es
About this study
Official title: 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.
- Conditions
- Foot Orthosis, Temperature
- Being tested
- Thermographic photo
- Keywords
- infrared thermography, orthopodia, thermometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermographic photoOther
Barefoot patient, thermographic photo of the sole of the feet is taken
| Study group | Role | What they receive |
|---|---|---|
| Termography PRE | Experimental | Foot thermography before lining test Receives: Other: Thermographic photo |
| Termography POST | Experimental | Foot thermography after wearing 2 types of liner for three hours (one on each foot) Receives: Other: Thermographic photo |
| Thermographic comparations | Active comparator | Thermographic comparations between PRE and POST measurements Receives: Other: Thermographic photo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: for a month
Secondary outcomes (1)
Foot temperature measurement POST
Photo after the use of linings inside the shoe
Measured: for a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start23 Dec 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot OrthosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Escamilla Martinez, Universidad de Extremadura
- Investigators
- ELENA ESCAMILLA MARTÍNEZ, Principal investigator, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268848
- Sponsor's protocol ID
- Termografiaforros2022
- Status last verified
- Feb 2022
- First submitted
- 22 Dec 2021
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Thermography With the Use of Different Plantar Orthosis Lining Materials
- ClinicalTrials.gov ID
- NCT05268848
- Acronym / sponsor ID
- Termografiaforros2022
- Conditions
- Foot Orthosis, Temperature
- Keywords
- infrared thermography, orthopodia, thermometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Termography PRE | Experimental | Other: Thermographic photoFoot thermography before lining test |
| Termography POST | Experimental | Other: Thermographic photoFoot thermography after wearing 2 types of liner for three hours (one on each foot) |
| Thermographic comparations | Active comparator | Other: Thermographic photoThermographic comparations between PRE and POST measurements |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- young or old people with respect to the age of study smokers or drinkers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermographic photoBarefoot patient, thermographic photo of the sole of the feet is taken | Other | Termography POST, Termography PRE, Thermographic comparations |
Primary outcome
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.
1 secondary outcome
Foot temperature measurement POST
Time frame: for a month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ELENA ESCAMILLA MARTÍNEZ principal investigator
University of Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermographic photo in people with Foot Orthosis and Temperature, run by Universidad de Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ELENA ESCAMILLA MARTÍNEZ (+34 927257000 ext. 52324, escaelen@unex.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot temperature measurement PRE (time frame: for a month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.