World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12615000370505
Date of registration: 23/04/2015
Prospective Registration: Yes
Primary sponsor: Universidad de Extremadura
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
Date of first enrolment: 27/04/2015
Target sample size: 35
Recruitment status: Not yet recruiting
URL:  https://anzctr.org.au/ACTRN12615000370505.aspx
Study type:  Interventional
Study design:  Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;  
Phase:  Not Applicable
Countries of recruitment
Spain
Contacts
Name: Dr Alfonso Martinez-Nova   
Address:  Centro Universitario de Plasencia Avda. Virgen del Puerto 2 10600 Plasencia Caceres Spain
Telephone: +34927257000
Email: podoalf@unex.es
Affiliation: 
Name: Dr Alfonso Martinez-Nova   
Address:  Centro Universitario de Plasencia Avda. Virgen del Puerto 2 10600 Plasencia Caceres Spain
Telephone: +34927257000
Email: podoalf@unex.es
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Male athletes with 1 year or more experience in running, with no dermatological diseases.
Exclusion criteria: Athletes with less than 1 year experience in running. Athletes with dermatological diseases or not sufficiently prepared to run 21 kms.

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Males
Health Condition(s) or Problem(s) studied
Skin microbial growth;Sweat of the foot ;Distribution of the foot´s temperature;
Skin microbial growth
Sweat of the foot
Distribution of the foot´s temperature
Skin - Dermatological conditions
Intervention(s)
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.
Primary Outcome(s)
Antimicrobial growth will be assessed with a skin capture

The capture will be taken at fifth metatarsal head of each foot[Before and immediately after the run]
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).[Before and immediately after run]
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[Before and immediately after the run]
Secondary Outcome(s)
A test of comfort will be bring to the athlete with a 5 point Likert Scale.[Before and immediately after the run ]
Secondary ID(s)
None
Source(s) of Monetary Support
Ekynox Wear, SL
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Comite Bioetica y Bioseguridad de la Universidad de Extremadura
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history