Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03914274
Other study ID # AMPPico
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2015
Est. completion date May 28, 2016

Study information

Verified date April 2019
Source University of Extremadura
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date May 28, 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Extremadura

References & Publications (43)

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. — View Citation

Arezes PM, Neves MM, Teixeira SF, Leão CP, Cunha JL. Testing thermal comfort of trekking boots: an objective and subjective evaluation. Appl Ergon. 2013 Jul;44(4):557-65. doi: 10.1016/j.apergo.2012.11.007. Epub 2013 Jan 12. — View Citation

Bogerd CP, Rechsteiner I, Wüst B, Rossi RM, Brühwiler PA. The effect of two sock fabrics on physiological parameters associated with blister incidence: a laboratory study. Ann Occup Hyg. 2011 Jun;55(5):510-8. doi: 10.1093/annhyg/meq099. — View Citation

Boulware DR, Forgey WW, Martin WJ 2nd. Medical risks of wilderness hiking. Am J Med. 2003 Mar;114(4):288-93. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Coughlin SS, Hatzigeorgiou C, Anglin J, Xie D, Besenyi GM, De Leo G, Stewart J, Wilkins T. Healthy lifestyle intervention for adult clinic patients with type 2 diabetes mellitus. Diabetes Manag (Lond). 2017;7(2):197-204. — View Citation

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. — View Citation

Dao H Jr, Kazin RA. Gender differences in skin: a review of the literature. Gend Med. 2007 Dec;4(4):308-28. Review. — View Citation

DiLiberto FE, Baumhauer JF, Nawoczenski DA. The prevention of diabetic foot ulceration: how biomechanical research informs clinical practice. Braz J Phys Ther. 2016 Nov 16;20(5):375-383. doi: 10.1590/bjpt-rbf.2014.0195. — View Citation

Dirksen G, Bachmann PA. [Occurrence of rota- and coronavirus as a cause of neonatal calf diarrhea in the Federal Republic of Germany]. Berl Munch Tierarztl Wochenschr. 1977 Dec 15;90(24):475-7. German. — View Citation

ElMakki Ahmed M, Tamimi AO, Mahadi SI, Widatalla AH, Shawer MA. Hallux ulceration in diabetic patients. J Foot Ankle Surg. 2010 Jan-Feb;49(1):2-7. doi: 10.1053/j.jfas.2009.07.005. — View Citation

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. — View Citation

Frederick EC. Kinematically mediated effects of sport shoe design: a review. J Sports Sci. 1986 Winter;4(3):169-84. — View Citation

González-Vargas S, Cortés-Reyes E, Marino-Isaza F. [Prevalence of musculoskeletal injuries in racing skaters in Villavicencio, Colombia]. Rev Salud Publica (Bogota). 2017 May-Jun;19(3):347-354. doi: 10.15446/rsap.v19n3.62976. Spanish. — View Citation

Heggie TW, Heggie TM. Viewing lava safely: an epidemiology of hiker injury and illness in Hawaii Volcanoes National Park. Wilderness Environ Med. 2004 Summer;15(2):77-81. — View Citation

Herring KM, Richie DH Jr. Comparison of cotton and acrylic socks using a generic cushion sole design for runners. J Am Podiatr Med Assoc. 1993 Sep;83(9):515-22. Erratum in: J Am Podiatr Med Assoc 1993 Nov;83(11):624. — View Citation

Herring KM, Richie DH Jr. Friction blisters and sock fiber composition. A double-blind study. J Am Podiatr Med Assoc. 1990 Feb;80(2):63-71. — View Citation

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. — View Citation

Jagoda A, Madden H, Hinson C. A friction blister prevention study in a population of marines. Mil Med. 1981 Jan;146(1):42-4. — View Citation

Janssen L, Allard NAE, Ten Haaf DSM, van Romburgh CPP, Eijsvogels TMH, Hopman MTE. First-Aid Treatment for Friction Blisters: "Walking Into the Right Direction?" Clin J Sport Med. 2018 Jan;28(1):37-42. doi: 10.1097/JSM.0000000000000424. — View Citation

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. — View Citation

Knapik JJ, Hamlet MP, Thompson KJ, Jones BH. Influence of boot-sock systems on frequency and severity of foot blisters. Mil Med. 1996 Oct;161(10):594-8. — View Citation

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. — View Citation

Leveque JL, Corcuff P, de Rigal J, Agache P. In vivo studies of the evolution of physical properties of the human skin with age. Int J Dermatol. 1984 Jun;23(5):322-9. — View Citation

McWhorter JW. The effects of loaded versus unloaded activities on foot volumetrics in older healthy adults. N Am J Sports Phys Ther. 2008 Feb;3(1):34-40. — View Citation

Najafi B, Mohseni H, Grewal GS, Talal TK, Menzies RA, Armstrong DG. An Optical-Fiber-Based Smart Textile (Smart Socks) to Manage Biomechanical Risk Factors Associated With Diabetic Foot Amputation. J Diabetes Sci Technol. 2017 Jul;11(4):668-677. doi: 10.1177/1932296817709022. Epub 2017 May 17. — View Citation

Niedermeier M, Einwanger J, Hartl A, Kopp M. Affective responses in mountain hiking-A randomized crossover trial focusing on differences between indoor and outdoor activity. PLoS One. 2017 May 16;12(5):e0177719. doi: 10.1371/journal.pone.0177719. eCollection 2017. — View Citation

Niedermeier M, Grafetstätter C, Hartl A, Kopp M. A Randomized Crossover Trial on Acute Stress-Related Physiological Responses to Mountain Hiking. Int J Environ Res Public Health. 2017 Aug 11;14(8). pii: E905. doi: 10.3390/ijerph14080905. — View Citation

Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253. — View Citation

Pérez-Pico AM, Marcos-Tejedor F, Iglesias-Sánchez MJ, Acevedo RM. Importance of Footwear for Preventing Xerosis and Hyperkeratosis in Older People with Psychiatric Disorders Living in an Institution. Int J Environ Res Public Health. 2018 Mar 24;15(4). pii: E584. doi: 10.3390/ijerph15040584. — View Citation

Peters P, Runge J. [Electronic plantar pressure measurements in different types of moutaineering boots]. Sportverletz Sportschaden. 2001 Jun;15(2):40-4. German. — View Citation

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. — View Citation

Schöffl V, Morrison A, Hefti U, Ullrich S, Küpper 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. — View Citation

Schöffl V, Morrison A, Schöffl I, Küpper 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. Review. — View Citation

Serrano MA, Cañada 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. — View Citation

Simpson KM, Munro BJ, Steele JR. Backpack load affects lower limb muscle activity patterns of female hikers during prolonged load carriage. J Electromyogr Kinesiol. 2011 Oct;21(5):782-8. doi: 10.1016/j.jelekin.2011.05.012. Epub 2011 Jun 25. — View Citation

Tayel AA, El-Tras WF, Abdel-Monem OA, El-Sabbagh SM, Alsohim AS, El-Refai EM. Production of anticandidal cotton textiles treated with oak gall extract. Rev Argent Microbiol. 2013 Oct-Dec;45(4):271-6. doi: 10.1016/S0325-7541(13)70036-1. — View Citation

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. — View Citation

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. — View Citation

Worthing RM, Percy RL, Joslin JD. Prevention of Friction Blisters in Outdoor Pursuits: A Systematic Review. Wilderness Environ Med. 2017 Jun;28(2):139-149. doi: 10.1016/j.wem.2017.03.007. Review. — View Citation

Zhong W, Xing MM, Pan N, Maibach HI. Textiles and human skin, microclimate, cutaneous reactions: an overview. Cutan Ocul Toxicol. 2006;25(1):23-39. Review. — View Citation

* Note: There are 43 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Temperature Were mearusedTemperatures in different parts of foot with an infrared thermometer (FTN "Medisana", precision 0.18ยบ 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
Secondary 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. 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
Secondary Weight 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
Secondary 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. The height onli was measured at the start of the walk in a single day: kilometer 0 of the route
See also
  Status Clinical Trial Phase
Completed NCT04539886 - Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions N/A
Not yet recruiting NCT05418959 - Genetic Risk Stratification of Pediatric Skin Lesions Phase 1
Recruiting NCT05068310 - Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors
Completed NCT05619471 - VIO Imaging for Skin Tissue Assessment (VISTA) N/A
Recruiting NCT03716193 - Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry N/A
Completed NCT04821193 - Comparison of the Effects of 5%NaHCO3, 2%CHG and 70%Alcohol in the Prevention of Infections Related to Catheter N/A
Completed NCT05729334 - Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions N/A
Completed NCT02598609 - SEPREVEN: a Stepped-wedge Randomised Controlled Trial N/A
Completed NCT06025058 - Neopep-S-based EasyDew MD Regen Cream for Radiotherapy Subject After Breast Tumor Resection N/A
Completed NCT05994781 - A Prospective Researcher-led Clinical Study of Neopep-S-based EasyDew MD Regen Cream N/A
Completed NCT00470912 - Sunscreen RV 2457C in Photoinduced CLE Phase 3
Completed NCT05410964 - Non-Linear Imaging of Skin In Vivo
Withdrawn NCT03357419 - The Effect of Prophylactic Antibiotics on Surgical Site Infection Lower Limb Skin Excisions N/A
Completed NCT02740257 - Smartphone Application to Detect Skin Lesions
Completed NCT03612570 - Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia N/A
Recruiting NCT03796871 - Medical Device Based on Polarized Light for Cutaneous Lesions Visualization N/A
Completed NCT05238870 - Prevention of Skin Damage in the Patient in Prone Position: Development of Education Interventions Based on a Training Needs Assessment Study.
Completed NCT05940090 - Correlation of Dermatologist Made Biopsy Decision With AI Assisted Total Body Photography Detection of Outlier Lesions
Enrolling by invitation NCT04566302 - Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy N/A
Completed NCT04470466 - Short Pulse and Q-switched ND-YAG Laser With Topical Carbon Versus Fractional CO2 Laser for Enlarged Facial Pores N/A