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

NCT04697914 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-04-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Universidad de Extremadura

    lead OTHER

Principal Investigators

  • Alfonso Martínez Nova, PhD · University of Extremadura

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-20
Primary Completion
2021-04-08
Completion
2021-04-20

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04697914 on ClinicalTrials.gov