NCT03914274

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2016

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

March 17, 2019

Last Update Submit

April 10, 2019

Conditions

Keywords

Sport Injury; Technical socks; Temperature; Hiking

Outcome Measures

Primary Outcomes (1)

  • lesions in foot developed during the hike

    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 Outcomes (4)

  • Temperature

    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

    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

    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"

    The height onli was measured at the start of the walk in a single day: kilometer 0 of the route

Study Arms (6)

Thermometer "FTN" "Medisana", precision 0.18º C),

NO INTERVENTION

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.

Non-elastic tape measure

NO INTERVENTION

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.

Bascule

NO INTERVENTION

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.

Altimeter

NO INTERVENTION

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.

Socks

EXPERIMENTAL

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

Geographical Position System Garmin "ETREX" 20

NO INTERVENTION

The height range and the pace hikers were controlled with a Garmin "ETREX" 20X Geographical Position System

Interventions

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).

Socks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (43)

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Study Officials

  • Raquel Mayordomo, Dr

    Universidad de Extremadura

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2019

First Posted

April 16, 2019

Study Start

October 10, 2015

Primary Completion

May 1, 2016

Study Completion

May 28, 2016

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share