跳至主要内容
临床试验/NCT04697914
NCT04697914已完成不适用

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

Universidad de Extremadura2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
2
主要终点
Change from Baseline in plantar temperature measurements.

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Change from Baseline in plantar temperature measurements.

时间窗: 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.

Change from Baseline in plantar pressures measurements.

时间窗: 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.

Change from Baseline foot confort wearing socks.

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Universidad de Extremadura
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alfonso Martínez Nova

Professor

Universidad de Extremadura

研究点 (2)

Loading locations...

相似试验