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

April 23, 2021 updated by: Alfonso Martínez Nova, Universidad de Extremadura

The Effect of a Discharge Sock Model in General and Thermal Comfort and Plantar Pressures: Randomized Controlled Trial.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Metatarsalgia is a common set of symptoms in the forefoot, characterized by pain under one or more metatarsal heads. First option should opt for conservative treatments, among these it is noteworthy the application of pressure relief elements from these anatomical zones. These elements, usually made of soft materials such as felt or foams of different compositions, are arranged covering the entire metatarsal area, with the exception of the compromised sector, that is, overloaded and painful, giving rise to discharge elements with a geometry similar to a U. In this way, the other areas of the metatarsus support the discharge element leaving exposed the overloaded area, so that it reduces or avoids its direct support on the support surface, thus mitigating the excess pressure in the compromised area and therefore, pain.. It is therefore desirable to have unloading elements of the metatarsal area, easy to use by a user and that do not involve major alterations in their usual clothing.

Different types of socks are known with configurations which give them beneficial effects on health. However, these existing models have not specifically focused on the plantar part of the sock, there is therefore no simple and economical solution for the protection of the metatarsus and the mitigation of pain and discomfort usually caused by its pathologies. This has been solved by the invention of a utility model, the U202030700, designed by the study's principal investigator and his research group.

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).

Specific objectives:

- To record the differences of plantar pressures, thermal and general confort with control socks and experimental socks after a briefs walks.

The type of intervention will be randomly assigned, meaning neither participant nor the secondary researchers knows the sock worn. The principal investigator (Alfonso Martínez Nova) will perform the randomization.

Participants. Subjects with pain in the plantar metatarsal area are suitable to participate in the study.

Participants will answer few questions and a podiatric exam to determine if meet the study requirements and then:

Answering a survey on health status and pain in the metatarsal area mainly. Collection of the necessary data (plantar pressures, foot temperature and confort wit the two kind of socks.

Materials: Experiment socks and control (same fiber, fabric, weight). Pressure platform Footscan. Flir e60bx thermographic camera.

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 second term, before and after a long walk (more than 1 hour).

The new sock aimed to protect the metatarsus and prevent the appearance of foot pain.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cáceres
      • Plasencia, Cáceres, Spain, 10600
        • Alfonso Martínez Nova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Sock
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.
to protect the metatarsus and prevent the appearance of foot pain.
Other Names:
  • 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.
Experimental: Experimental Relief Pressure sock
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.
to protect the metatarsus and prevent the appearance of foot pain.
Other Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in plantar pressures measurements.
Time Frame: 10 minutes (first experiment) and more than 1 hour (second experiment)
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.
Time Frame: 10 minutes (first experiment) and more than 1 hour (second experiment)
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.
Time Frame: 10 minutes (first experiment) and more than 1 hour (second experiment)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Extremadura

Investigators

  • Principal Investigator: Alfonso Martínez Nova, PhD, University of Extremadura

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2021

Primary Completion (Actual)

April 8, 2021

Study Completion (Actual)

April 20, 2021

Study Registration Dates

First Submitted

December 16, 2020

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INDIGO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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