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

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ClinicalTrials.gov Identifier: NCT04098055
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Pedro V. Munuera-Martínez, University of Seville

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

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Foot Orthoses Musculoskeletal Pain Device: Custom-Made Foot Orthoses Device: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Effectiveness of Custom-made Foot Orthoses in Patients With Systemic Lupus Erythematous
Estimated Study Start Date : November 2, 2019
Estimated Primary Completion Date : February 2, 2021
Estimated Study Completion Date : November 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health Lupus

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098055


Contacts
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Contact: Pedro V. Munuera-Martínez, PhD. +34954486526 pmunuera@us.es

Sponsors and Collaborators
University of Seville

Publications of Results:
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Responsible Party: Pedro V. Munuera-Martínez, Director, University of Seville
ClinicalTrials.gov Identifier: NCT04098055     History of Changes
Other Study ID Numbers: SLE
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pedro V. Munuera-Martínez, University of Seville:
Lupus Erythematosus, Systemic
Foot Orthoses
Foot
Pain
Additional relevant MeSH terms:
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Musculoskeletal Pain
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms