The Effect of a Discharge Sock Model in Comfort: Randomized Controlled Trial
Primary Purpose
Foot Diseases, Metatarsalgia, Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
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.
Sponsored by
About this trial
This is an interventional prevention trial for Foot Diseases focused on measuring foot, metatarsalgia, pain, pressure relief, socks, confort
Eligibility Criteria
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.
Sites / Locations
- Alfonso Martínez Nova
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control Sock
Experimental Relief Pressure sock
Arm Description
Control comercial Socks (Lurbel Tierra). These socks are designed to perform trekking.
Experimental Socks (Lurbel Tierra based), with a discharge element (in the own fabric and fibres of the sock).
Outcomes
Primary Outcome Measures
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.
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.
Change from Baseline foot confort wearing socks.
An standardized confort survey about different issues of the socks will be fulfilled before and after walking.
Secondary Outcome Measures
Full Information
NCT ID
NCT04697914
First Posted
December 16, 2020
Last Updated
April 23, 2021
Sponsor
Universidad de Extremadura
1. Study Identification
Unique Protocol Identification Number
NCT04697914
Brief Title
The Effect of a Discharge Sock Model in Comfort: Randomized Controlled Trial
Official Title
The Effect of a Discharge Sock Model in General and Thermal Comfort and Plantar Pressures: Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 20, 2021 (Actual)
Primary Completion Date
April 8, 2021 (Actual)
Study Completion Date
April 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Extremadura
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Diseases, Metatarsalgia, Pain
Keywords
foot, metatarsalgia, pain, pressure relief, socks, confort
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Sock
Arm Type
Placebo Comparator
Arm Description
Control comercial Socks (Lurbel Tierra). These socks are designed to perform trekking.
Arm Title
Experimental Relief Pressure sock
Arm Type
Experimental
Arm Description
Experimental Socks (Lurbel Tierra based), with a discharge element (in the own fabric and fibres of the sock).
Intervention Type
Diagnostic Test
Intervention Name(s)
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.
Other Intervention Name(s)
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.
Intervention Description
to protect the metatarsus and prevent the appearance of foot pain.
Primary Outcome Measure Information:
Title
Change from Baseline in plantar pressures measurements.
Description
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.
Time Frame
10 minutes (first experiment) and more than 1 hour (second experiment)
Title
Change from Baseline in plantar temperature measurements.
Description
An infrared camera (Flir e60bx) will measure skin temperature. This study mapped out five subregions of anatomic interest over the foot.
Time Frame
10 minutes (first experiment) and more than 1 hour (second experiment)
Title
Change from Baseline foot confort wearing socks.
Description
An standardized confort survey about different issues of the socks will be fulfilled before and after walking.
Time Frame
10 minutes (first experiment) and more than 1 hour (second experiment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfonso Martínez Nova, PhD
Organizational Affiliation
University of Extremadura
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfonso Martínez Nova
City
Plasencia
State/Province
Cáceres
ZIP/Postal Code
10600
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34205056
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of a Discharge Sock Model in Comfort: Randomized Controlled Trial
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