Skin LesionNCT03914274

Adequate Sock to Avoid Hiking Injuries

A study testing Technical sock in people with Skin Lesion, run by University of Extremadura.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Skin Lesion
What is being tested?: Technical sock
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 109 participants
Where: No sites listed yet
Study dates: 10 Oct 2015to 28 May 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

Not meet any inclusion criteria.

About this study

Official title: 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.

Read the 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.

Conditions: Skin Lesion
Being tested: Technical sock
Keywords: Sport Injury; Technical socks; Temperature; Hiking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Technical sockDevice
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).

Study groups in NCT03914274
Study group	Role	What they receive
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 Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Weight was measured using scales (Tanita UM-076, precision 0.1kg).Three measurements were done and their media was calculated.
Measured: 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"
Height was measured using the weight rod of differents scales (SECA 704, precision 1 mm). Three measurements were done and their media was calculated.
Measured: The height onli was measured at the start of the walk in a single day: kilometer 0 of the route

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 201528 May 2016

First posted16 Apr 2019
Study start10 Oct 2015
Primary completionMay 2016
Study completion28 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (43)Papers the sponsor has linked to this study.
Other trials for Skin LesionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03914274
Sponsor's protocol ID: AMPPico
Status last verified: Apr 2019
First submitted: 17 Mar 2019
Last updated: 16 Apr 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Wannop JW, Worobets JT, Ruiz R, Stefanyshyn DJ. Footwear traction and three-dimensional kinematics of level, downhill, uphill and cross-slope walking. Gait Posture. 2014;40(1):118-22. doi: 10.1016/j.gaitpost.2014.03.004. Epub 2014 Mar 13.
PubMed 24684947
Fattorini L, Pittiglio G, Federico B, Pallicca A, Bernardi M, Rodio A. Workload comparison between hiking and indoor physical activity. J Strength Cond Res. 2012 Oct;26(10):2883-9. doi: 10.1519/JSC.0b013e318242a61e.
PubMed 22158090
Brandenburg WE, Locke BW. Mountain medical kits: epidemiology-based recommendations and analysis of medical supplies carried by mountain climbers in Colorado. J Travel Med. 2017 Mar 1;24(2). doi: 10.1093/jtm/taw088.
PubMed 28395094
Serrano MA, Canada J, Moreno JC. Ultraviolet exposure for different outdoor sports in Valencia, Spain. Photodermatol Photoimmunol Photomed. 2011 Dec;27(6):311-7. doi: 10.1111/j.1600-0781.2011.00620.x.
PubMed 22092735
Pigman J, Sullivan W, Leigh S, Hosick PA. The Effect of a Backpack Hip Strap on Energy Expenditure While Walking. Hum Factors. 2017 Dec;59(8):1214-1221. doi: 10.1177/0018720817730179. Epub 2017 Sep 11.
PubMed 28892419
Anderson LS Jr, Rebholz CM, White LF, Mitchell P, Curcio EP 3rd, Feldman JA, Kahn JH. The impact of footwear and packweight on injury and illness among long-distance hikers. Wilderness Environ Med. 2009 Fall;20(3):250-6. doi: 10.1580/08-WEME-OR-196R2.1.
PubMed 19737037
Dahl KD, Wang H, Popp JK, Dickin DC. Load distribution and postural changes in young adults when wearing a traditional backpack versus the BackTpack. Gait Posture. 2016 Mar;45:90-6. doi: 10.1016/j.gaitpost.2016.01.012. Epub 2016 Jan 22.
PubMed 26979888
Jacobson BH, Wright T. A field test comparison of hiking stick use on heartrate and rating of perceived exertion. Percept Mot Skills. 1998 Oct;87(2):435-8. doi: 10.2466/pms.1998.87.2.435.
PubMed 9842582
Brennan FH Jr, Jackson CR, Olsen C, Wilson C. Blisters on the battlefield: the prevalence of and factors associated with foot friction blisters during Operation Iraqi Freedom I. Mil Med. 2012 Feb;177(2):157-62. doi: 10.7205/milmed-d-11-00325.
PubMed 22360060
Schoffl V, Morrison A, Hefti U, Ullrich S, Kupper T. The UIAA Medical Commission injury classification for mountaineering and climbing sports. Wilderness Environ Med. 2011 Mar;22(1):46-51. doi: 10.1016/j.wem.2010.11.008. Epub 2010 Nov 16.
PubMed 21377118
Schoffl V, Morrison A, Schoffl I, Kupper T. The epidemiology of injury in mountaineering, rock and ice climbing. Med Sport Sci. 2012;58:17-43. doi: 10.1159/000338575. Epub 2012 Jul 18.
PubMed 22824837
Kirkham S, Lam S, Nester C, Hashmi F. The effect of hydration on the risk of friction blister formation on the heel of the foot. Skin Res Technol. 2014 May;20(2):246-53. doi: 10.1111/srt.12136. Epub 2014 Mar 20.
PubMed 24645912
Knapik JJ, Reynolds K, Barson J. Influence of an antiperspirant on foot blister incidence during cross-country hiking. J Am Acad Dermatol. 1998 Aug;39(2 Pt 1):202-6. doi: 10.1016/s0190-9622(98)70075-1.
PubMed 9704829
Van Tiggelen D, Wickes S, Coorevits P, Dumalin M, Witvrouw E. Sock systems to prevent foot blisters and the impact on overuse injuries of the knee joint. Mil Med. 2009 Feb;174(2):183-9. doi: 10.7205/milmed-d-01-8508.
PubMed 19317200
Choi SC, Min YG, Lee IS, Yoon GH, Kang BR, Jung YS, Cho JP, Kim GW. Injuries associated with the 580 km university student grand voluntary road march: focus on foot injuries. J Korean Med Sci. 2013 Dec;28(12):1814-21. doi: 10.3346/jkms.2013.28.12.1814. Epub 2013 Nov 26.
PubMed 24339714

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Skin Lesion trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Importance of Sock Type in the Development of Foot Lesions on Low-difficulty, Short Hikes
ClinicalTrials.gov ID: NCT03914274
Acronym / sponsor ID: AMPPico
Conditions: Skin Lesion
Keywords: Sport Injury; Technical socks; Temperature; Hiking
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: University of ExtremaduraUniversity, hospital or other
Study start: 10 Oct 2015 (actual)
Primary completion: May 2016 (actual)
Study completion: 28 May 2016 (actual)
First posted: 16 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
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	Device: Technical sockSocks 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
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

Not meet any inclusion criteria.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Technical sockSocks 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).	Device	Socks

Primary outcome

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.

4 secondary outcomes

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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
Background: PubMed 24684947Wannop JW, Worobets JT, Ruiz R, Stefanyshyn DJ. Footwear traction and three-dimensional kinematics of level, downhill, uphill and cross-slope walking. Gait Posture. 2014;40(1):118-22. doi: 10.1016/j.gaitpost.2014.03.004. Epub 2014 Mar 13.
Background: PubMed 22158090Fattorini L, Pittiglio G, Federico B, Pallicca A, Bernardi M, Rodio A. Workload comparison between hiking and indoor physical activity. J Strength Cond Res. 2012 Oct;26(10):2883-9. doi: 10.1519/JSC.0b013e318242a61e.
Background: PubMed 28395094Brandenburg WE, Locke BW. Mountain medical kits: epidemiology-based recommendations and analysis of medical supplies carried by mountain climbers in Colorado. J Travel Med. 2017 Mar 1;24(2). doi: 10.1093/jtm/taw088.
Background: PubMed 22092735Serrano MA, Canada J, Moreno JC. Ultraviolet exposure for different outdoor sports in Valencia, Spain. Photodermatol Photoimmunol Photomed. 2011 Dec;27(6):311-7. doi: 10.1111/j.1600-0781.2011.00620.x.
Background: PubMed 28892419Pigman J, Sullivan W, Leigh S, Hosick PA. The Effect of a Backpack Hip Strap on Energy Expenditure While Walking. Hum Factors. 2017 Dec;59(8):1214-1221. doi: 10.1177/0018720817730179. Epub 2017 Sep 11.
Background: PubMed 19737037Anderson LS Jr, Rebholz CM, White LF, Mitchell P, Curcio EP 3rd, Feldman JA, Kahn JH. The impact of footwear and packweight on injury and illness among long-distance hikers. Wilderness Environ Med. 2009 Fall;20(3):250-6. doi: 10.1580/08-WEME-OR-196R2.1.
Background: PubMed 26979888Dahl KD, Wang H, Popp JK, Dickin DC. Load distribution and postural changes in young adults when wearing a traditional backpack versus the BackTpack. Gait Posture. 2016 Mar;45:90-6. doi: 10.1016/j.gaitpost.2016.01.012. Epub 2016 Jan 22.
Background: PubMed 9842582Jacobson BH, Wright T. A field test comparison of hiking stick use on heartrate and rating of perceived exertion. Percept Mot Skills. 1998 Oct;87(2):435-8. doi: 10.2466/pms.1998.87.2.435.
Background: PubMed 22360060Brennan FH Jr, Jackson CR, Olsen C, Wilson C. Blisters on the battlefield: the prevalence of and factors associated with foot friction blisters during Operation Iraqi Freedom I. Mil Med. 2012 Feb;177(2):157-62. doi: 10.7205/milmed-d-11-00325.
Background: PubMed 21377118Schoffl V, Morrison A, Hefti U, Ullrich S, Kupper T. The UIAA Medical Commission injury classification for mountaineering and climbing sports. Wilderness Environ Med. 2011 Mar;22(1):46-51. doi: 10.1016/j.wem.2010.11.008. Epub 2010 Nov 16.
Background: PubMed 22824837Schoffl V, Morrison A, Schoffl I, Kupper T. The epidemiology of injury in mountaineering, rock and ice climbing. Med Sport Sci. 2012;58:17-43. doi: 10.1159/000338575. Epub 2012 Jul 18.
Background: PubMed 24645912Kirkham S, Lam S, Nester C, Hashmi F. The effect of hydration on the risk of friction blister formation on the heel of the foot. Skin Res Technol. 2014 May;20(2):246-53. doi: 10.1111/srt.12136. Epub 2014 Mar 20.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Raquel Mayordomo, Dr study director

Universidad de Extremadura

Questions about this trial

What is this clinical trial studying?

A study testing Technical sock in people with Skin Lesion, run by University of Extremadura.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03914274, which also lists 43 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019; AzTrials last refreshed its copy on 31 Oct 2026.