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Adequate Sock to Avoid Hiking Injuries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914274
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ana María Pérez Pico, University of Extremadura

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.


Condition or disease Intervention/treatment Phase
Skin Lesion Device: Technical sock Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Importance of Sock Type in the Development of Foot Lesions on Low-difficulty, Short Hikes
Actual Study Start Date : October 10, 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 28, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914274


Sponsors and Collaborators
University of Extremadura
Investigators
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Study Director: Raquel Mayordomo, Dr Universidad de Extremadura
  Study Documents (Full-Text)

Documents provided by Ana María Pérez Pico, University of Extremadura:
Informed Consent Form  [PDF] April 9, 2019

Publications:

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Responsible Party: Ana María Pérez Pico, Principal Investigator, University of Extremadura
ClinicalTrials.gov Identifier: NCT03914274    
Other Study ID Numbers: AMPPico
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana María Pérez Pico, University of Extremadura:
Sport Injury; Technical socks; Temperature; Hiking