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: |
|
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 ]
|
Source(s) of Monetary Support
|
Ekynox Wear, SL
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Comite Bioetica y Bioseguridad de la Universidad de Extremadura
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|