Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000370505
Ethics application status
Approved
Date submitted
15/02/2015
Date registered
23/04/2015
Date last updated
23/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Antimicrobial, thermal and perspiration effects in socks with bioceramic fibers
Scientific title
The effect of wearing socks with bioceramic fibers on microbial growth, perspiration and thermal distribution in male adult runners
Secondary ID [1] 286179 0
None
Universal Trial Number (UTN)
Trial acronym
ATAPESBIO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin microbial growth 294205 0
Sweat of the foot 294206 0
Distribution of the foot´s temperature 294207 0
Condition category
Condition code
Skin 294520 294520 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention A: A sock with bioceramic fibers will bring to the athlete. Then three tests will be made, Capture of microbiological sample in the fifth metatarsal head of the foot, a sweat test in 5 or more zones of the foot, and thermographic images will be taken. This sock will be placed in at random foot

Intervention B: A control sock (made with not bioceramic fibers) will bring to the athlete. Then three tests will be made, Capture of microbiological sample in the fifth metatarsal head of the foot, a sweat test in 5 or more zones of the foot, and thermographic images will be taken.This sock will be placed in the other foot.

Athletes have to made a run (21 km) with this two different socks in their foot. After the run the three tests will be repeated in both feet.
Intervention code [1] 291187 0
Treatment: Devices
Intervention code [2] 291640 0
Prevention
Comparator / control treatment
Application of control sock. Is the same as intervention B.
Control group
Placebo

Outcomes
Primary outcome [1] 294303 0
Antimicrobial growth will be assessed with a skin capture

The capture will be taken at fifth metatarsal head of each foot
Timepoint [1] 294303 0
Before and immediately after the run
Primary outcome [2] 294818 0
Thermal images will be taken with a FLIR camera.

Foot temperature will be measured in heel, external and internal, midfoot, first metatarsal head, central metatarsals, fifth metatarsal head, hallux, central toes and lateral toes. In dorsal, zone will be the same (except heel).
Timepoint [2] 294818 0
Before and immediately after run
Primary outcome [3] 294819 0
Perspiration measure will be taken with a hydro-sensor

5 measurements points will be made. heel, first metatarsal head, fifht metatarsal head, midfoot (external) and a dorsal measurement in the proximal 2nd metatarsal
Timepoint [3] 294819 0
Before and immediately after the run
Secondary outcome [1] 312996 0
A test of comfort will be bring to the athlete with a 5 point Likert Scale.
Timepoint [1] 312996 0
Before and immediately after the run

Eligibility
Key inclusion criteria
Male athletes with 1 year or more experience in running, with no dermatological diseases.
Minimum age
18 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Athletes with less than 1 year experience in running. Athletes with dermatological diseases or not sufficiently prepared to run 21 kms.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/04/2015
Actual
Date of last participant enrolment
Anticipated
4/05/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment outside Australia
Country [1] 6661 0
Spain
State/province [1] 6661 0
Caceres

Funding & Sponsors
Funding source category [1] 290749 0
Commercial sector/Industry
Name [1] 290749 0
Ekynox Wear, SL
Country [1] 290749 0
Spain
Primary sponsor type
University
Name
Universidad de Extremadura
Address
Centro Universitario de Plasencia
Avda. Virgen del Puerto 2
10600 Plasencia
Caceres
Country
Spain
Secondary sponsor category [1] 289433 0
None
Name [1] 289433 0
Address [1] 289433 0
Country [1] 289433 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292379 0
Comite Bioetica y Bioseguridad de la Universidad de Extremadura
Ethics committee address [1] 292379 0
Ethics committee country [1] 292379 0
Spain
Date submitted for ethics approval [1] 292379 0
Approval date [1] 292379 0
03/03/2015
Ethics approval number [1] 292379 0

Summary
Brief summary
This study is a randomized controlled trial in healthy athletes which aims to determine the beneficial effects (in microbial growth, sweat and thermal regulation) of socks with bioceramic fibers. It is hoped that information gathered from this project will help to contribute to the body of knowledge to an optimal podiatry prevention of skin diseases in athletes
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54934 0
Dr Alfonso Martinez-Nova
Address 54934 0
Centro Universitario de Plasencia
Avda. Virgen del Puerto 2
10600 Plasencia
Caceres
Country 54934 0
Spain
Phone 54934 0
+34927257000
Fax 54934 0
Email 54934 0
[email protected]
Contact person for public queries
Name 54935 0
Dr Alfonso Martinez-Nova
Address 54935 0
Centro Universitario de Plasencia
Avda. Virgen del Puerto 2
10600 Plasencia
Caceres
Country 54935 0
Spain
Phone 54935 0
+34927257000
Fax 54935 0
Email 54935 0
[email protected]
Contact person for scientific queries
Name 54936 0
Dr Alfonso Martinez-Nova
Address 54936 0
Centro Universitario de Plasencia
Avda. Virgen del Puerto 2
10600 Plasencia
Caceres
Country 54936 0
Spain
Phone 54936 0
+34927257000
Fax 54936 0
Email 54936 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.