Effect of Insoles in Patients With Systemic Lupus Erythematosus (EISLE)

May 18, 2022 updated by: Pedro V. Munuera-Martínez, University of Seville

Effectiveness of Custom-made Foot Orthoses in Patients With Systemic Lupus Erythematous

Demonstrate that custom-made insoles improve painful symptomatology, health and foot function in subjects with SLE and podiatric involvement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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
      • Seville, Spain, 41009
        • Department of Podiatry

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or more.
  • Medical diagnosis of LES.
  • Foot involvement.

Exclusion Criteria:

  • Treatment with foot orthoses.
  • LES with acute symptomatic flare.
  • Ulcers.
  • Skin involvement.
  • Neurological problems.
  • Cognitive deterioration.
  • Need for walking assistance.
  • Refused to change footwear to use the foot orthoses.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
Device: Placebo
The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam.
Experimental: Custom-made foot orthoses
Device: Custom-Made Foot Orthoses
The foot orthoses were custom made using phenolic foam molds of the feet. They consisted of a polypropylene layer of 2 mm from heel to just proximal to the metatarsal heads, an upper sheet of 30 Shore A polyethylene foam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
11-point Numeric Pain Rating Scale
Time Frame: 1 minute
With a range of 0 = no pain to 10 = pain as bad as it can be.
1 minute
SF- 12 Quality of Life
Time Frame: 10 minutes
To describe the relationships among functional health status measures. This has values between 0 and 100, with higher values corresponding to lower quality of life.
10 minutes
Foot Function
Time Frame: 5 minutes
Foot Function Index
5 minutes
Foot Disability
Time Frame: 5 minutes
Manchester Foot Pain and Disability Index
5 minutes

Collaborators and Investigators

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

Sponsor

University of Seville

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)

November 2, 2019

Primary Completion (Actual)

February 2, 2021

Study Completion (Actual)

February 2, 2022

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLE

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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