The Effect of a Discharge Sock Model in Comfort: Randomized Controlled Trial

NCT04697914 | Completed DMC

• 1 other identifier: INDIGO
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Metatarsalgia is a common set of symptoms in the forefoot, characterized by pain under one or more metatarsal heads. The invention of a utility model, the U202030700, designed by the study's principal investigator aims to protect the metatarsus and prevent the appearance of foot pain. The hypothesis of this research project is based on the fact that using our proposed sock with metatarsal discharge plate will bring advantages in terms of pain reduction, increased comfort, temperature reduction and change in plantar pressures received in the second and third metatarsals joint area versus the use of control socks (without discharge plate). Participants will be subjects with pain in the plantar metatarsal area that will answer few questions and a podiatric exam to determine if meet the study requirements and then a plantar pressures, foot temperature and confort wit the two kind of socks will be taken. Confort survey, thermal pictures and plantar pressures will be taken (in first term) before and after a brief walk (5 to 10 minutes) and in a second experiment (second term) after a long walk (more than 1 hour).

Conditions

Foot Diseases; Metatarsalgia; Pain

Keywords

foot; metatarsalgia; pain; pressure relief; socks; confort

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in plantar pressures measurements.

  Plantar pressures will be measured in 7 zones using the Footscan® platform following the two-step method. Three plantar pressures measurements were made for each foot.

  10 minutes (first experiment) and more than 1 hour (second experiment)

• Change from Baseline in plantar temperature measurements.

  An infrared camera (Flir e60bx) will measure skin temperature. This study mapped out five subregions of anatomic interest over the foot.

  10 minutes (first experiment) and more than 1 hour (second experiment)

• Change from Baseline foot confort wearing socks.

  An standardized confort survey about different issues of the socks will be fulfilled before and after walking.

  10 minutes (first experiment) and more than 1 hour (second experiment)

Study Arms (2)

Control Sock

PLACEBO COMPARATOR

Control comercial Socks (Lurbel Tierra). These socks are designed to perform trekking.

Diagnostic Test: Plantar pressures will be measured in 7 zones using the Footscan® platform following the two-step method. Three plantar pressures measurements were made for each foot.

Experimental Relief Pressure sock

EXPERIMENTAL

Experimental Socks (Lurbel Tierra based), with a discharge element (in the own fabric and fibres of the sock).

Diagnostic Test: Plantar pressures will be measured in 7 zones using the Footscan® platform following the two-step method. Three plantar pressures measurements were made for each foot.

Interventions

Plantar pressures will be measured in 7 zones using the Footscan® platform following the two-step method. Three plantar pressures measurements were made for each foot. DIAGNOSTIC_TEST

to protect the metatarsus and prevent the appearance of foot pain.

Also known as: Thermal picture. An infrared camera (Flir e60bx) will measure skin temperature. This study mapped out five subregions of anatomic interest over the foot., Confort survey. An standardized confort survey about different issues of the socks will be fulfilled before and after walking.

Control Sock; Experimental Relief Pressure sock

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects with mild discomfort in the plantar metatarsal area of the foot

You may not qualify if:

• Subjects with severe disorders of the foot, gait impairment, foot deformations.

Sponsors & Collaborators

• Universidad de Extremadura: lead

Study Sites (1)

Alfonso Martínez Nova

Plasencia, Cáceres, 10600, Spain

Location

Related Publications (1)

• Martinez-Nova A, Jimenez-Cano VM, Caracuel-Lopez JM, Gomez-Martin B, Escamilla-Martinez E, Sanchez-Rodriguez R. Effectiveness of a Central Discharge Element Sock for Plantar Temperature Reduction and Improving Comfort. Int J Environ Res Public Health. 2021 Jun 3;18(11):6011. doi: 10.3390/ijerph18116011.

  PMID: 34205056 DERIVED

MeSH Terms

Conditions

Foot Diseases; Metatarsalgia; Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alfonso Martínez Nova, PhD

  University of Extremadura

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 6, 2021
• Study Start: February 20, 2021
• Primary Completion: April 8, 2021
• Study Completion: April 20, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)