Adequate Sock to Avoid Hiking Injuries

April 10, 2019 updated by: Ana María Pérez Pico, University of Extremadura

Importance of Sock Type in the Development of Foot Lesions on Low-difficulty, Short Hikes

Foot lesions can be developed during hiking because of external factors. This makes it important to study the effect of hiking equipment on lesion development.

This study analyzes the extrinsic factors involved in the appearance of injuries at the feet during the realization of a route of low difficulty and short travel. 33 participants wore cotton not technicians socks in his two feet, were used like control socks and 76 participants wore technical socks "Tierra" and "Set" one on each foot.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Socks it used as an indispensable element to protect the foot of injuries during sports practice. The different compositions of socks can influence the appearance of injuries. The technical socks are designed for high-performance sports use ("Lurbel" brand, models "Tierra" and "Set"), and non-technical socks (cotton) for everyday use. The socks had different composition: "Tierra" (50% regenerative, 25% cool-teak, 17% polyamide ions, 8% lycra); "Set" (75% cotton, 17% polyamide, 8% lycra) and cotton (98% cotton, 2% elastane). The technical socks had reinforced weave in the toe, metatarsal and heel areas.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The admission criteria were: be of legal age, have no current health problems that would hinder or prevent participation in the hike, and carry a backpack weighing less than 3 kg. Participants were asked to use specific hiking footwear (light, flexible, soft-soled, with good grip and breathable material) (low top hiking shoes), based on earlier studies 38-40. They were also asked to do the entire hike following the instructions of an experienced guide and to not remove their footwear or socks before examination by a podiatrist.

Exclusion Criteria:

  • Not meet any inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Thermometer "FTN" "Medisana", precision 0.18º C),

Temperatures were taken with an infrared thermometer "FTN" "Medisana", precision 0.18º C.

The temperature will be taken into account to see if it will vary according to the socket used as the temperature is a favoring element of dermic injuries on the feet.
NO_INTERVENTION: Non-elastic tape measure

Perimeter was measured with a flexible, non-elastic tape measure "Lawton 18-0160", precision 1 mm.

The measurement of the feet perimeters will be taken into account to see if it will vary according to the socket used and related to injuries in the feet.
NO_INTERVENTION: Bascule
Weight was measured using scales ("Tanita" UM-076, precision 0.1kg). The scale is used to control the weight of the participants in order to find out their body mass index since the weight can influence the appearance of lesions on the feet.
NO_INTERVENTION: Altimeter
Height was measured using the weight rod of different scales "SECA 704", precision 1 mm) The altimeter is used to measure the participants in order to find out their body mass index.
EXPERIMENTAL: Socks

Socks were of two types: technical socks, designed for high performance sports use "Lurbel brand, models Tierra and Set", and non-technical socks for everyday use. The socks had different composition: "Tierra:50% regeneractiv, 25% cool-teak, 17% polyamide ions, 8% lycra"; "Set:75% cotton, 17% polyamide, 8% lycra" and "cotton: 98% cotton, 2% elastane".

Different socks were given to the participants to see if the different compositions influenced the appearance of injuries in a short route route and little difficulty
Device: Technical sock
Socks were of two types: technical socks, designed for high performance sports use (Lurbel brand, models Tierra and Set), and non-technical socks for everyday use. The socks had different composition: Tierra (50% regeneractiv, 25% cool-teak, 17% polyamide ions, 8% lycra); Set (75% cotton, 17% polyamide, 8% lycra) and cotton (98% cotton, 2% elastane).
NO_INTERVENTION: Geographical Position System Garmin "ETREX" 20
The height range and the pace hikers were controlled with a Garmin "ETREX" 20X Geographical Position System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lesions in foot developed during the hike
Time Frame: The development of the injuries in a single day of sport activity was observed: kilometer 0 of the route, kilometer 14.5 of the route and kilometer 29.6 of the route.
All dermal lesions that developed during the walk (both keratopathies with keratinization disorder and dermatopathies without keratinization disorder) Blister, Injury, (Erosion & chafing), Reddened skin, Urticaria, Crevice, Heloma, all the muscle injuries that developed during the walk (Pain, Inflammation, Muscle discomfort or Sprain) and all the lesions in the skin were analyzed. the nails that developed during the walk, both traumatic and non-traumatic (onycopathies) Onychocryptosis, Subungual hematoma.
The development of the injuries in a single day of sport activity was observed: kilometer 0 of the route, kilometer 14.5 of the route and kilometer 29.6 of the route.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temperature
Time Frame: The temperature was measured in three occasions in a single day: kilometer 0 of the route, kilometer 14.5 of the route and kilometer 29.6 of the route
Were mearusedTemperatures in different parts of foot with an infrared thermometer (FTN "Medisana", precision 0.18º C). Three measurements were done and their media was calculated.
The temperature was measured in three occasions in a single day: kilometer 0 of the route, kilometer 14.5 of the route and kilometer 29.6 of the route
Perimeter
Time Frame: The perimeter was measured in three occasions in a single day: kilometer 0 of the route, kilometer 14.5 of the route and kilometer 29.6 of the route
Perimeter in different parts of foot with a flexible, non-elastic tape measure (Lawton 18-0160, precision 1 mm).Three measurements were done and their media was calculated. Three measurements were done and their media was calculated.
The perimeter was measured in three occasions in a single day: kilometer 0 of the route, kilometer 14.5 of the route and kilometer 29.6 of the route
Weight
Time Frame: The weight was measured in three occasions in a single day: kilometer 0 of the route, kilometer 14.5 of the route and kilometer 29.6 of the route
Weight was measured using scales (Tanita UM-076, precision 0.1kg).Three measurements were done and their media was calculated.
The weight was measured in three occasions in a single day: kilometer 0 of the route, kilometer 14.5 of the route and kilometer 29.6 of the route
Height at the start of the route for calculate "BMI"
Time Frame: The height onli was measured at the start of the walk in a single day: kilometer 0 of the route
Height was measured using the weight rod of differents scales (SECA 704, precision 1 mm). Three measurements were done and their media was calculated.
The height onli was measured at the start of the walk in a single day: kilometer 0 of the route

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Extremadura

Investigators

  • Study Director: Raquel Mayordomo, Dr, Universidad de Extremadura

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 10, 2015

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 28, 2016

Study Registration Dates

First Submitted

March 17, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (ACTUAL)

April 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AMPPico

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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