Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04697914 |
| Other study ID # |
INDIGO |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 20, 2021 |
| Est. completion date |
April 20, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Universidad de Extremadura |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
