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Completed

NCT Number: NCT04098055

Effect of Insoles in Patients With Systemic Lupus Erythematosus

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

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Key information

Conditions

Lupus Erythematosus, Systemic Autoimmune Diseases Connective Tissue Diseases Foot Orthoses Immune System Diseases Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Podiatry

Seville, 41009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Custom-Made Foot Orthoses

Device

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.

PLACEBO

Device

The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam.

Primary outcomes

  1. 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.

  2. 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.

  3. Foot Function

    Time frame: 5 minutes

    Foot Function Index

  4. Foot Disability

    Time frame: 5 minutes

    Manchester Foot Pain and Disability Index

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Acronym: EISLE

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 20, 2019
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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