NCT04098055

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 2, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

1.3 years

First QC Date

September 18, 2019

Last Update Submit

May 18, 2022

Conditions

Lupus Erythematosus, SystemicFoot OrthosesMusculoskeletal Pain

Keywords

Lupus Erythematosus, SystemicFoot OrthosesFootPain

Outcome Measures

Primary Outcomes (4)

  • 11-point Numeric Pain Rating Scale

    With a range of 0 = no pain to 10 = pain as bad as it can be.

    1 minute

  • SF- 12 Quality of Life

    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

    Foot Function Index

    5 minutes

  • Foot Disability

    Manchester Foot Pain and Disability Index

    5 minutes

Study Arms (2)

Custom-made foot orthoses

EXPERIMENTAL
Device: Custom-Made Foot Orthoses

Control Group

PLACEBO COMPARATOR
Device: Placebo

Interventions

Custom-Made Foot OrthosesDEVICE

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.

Custom-made foot orthoses
PlaceboDEVICE

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

Control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Podiatry

Seville, 41009, Spain

Location

Related Publications (4)

  • Pipili C, Sfritzeri A, Cholongitas E. Deforming arthropathy in systemic lupus erythematosus. Eur J Intern Med. 2008 Nov;19(7):482-7. doi: 10.1016/j.ejim.2008.01.017. Epub 2008 Apr 1.

    PMID: 19013374RESULT

  • Otter SJ, Kumar S, Gow P, Dalbeth N, Corkill M, Rohan M, Davies KA, Pankathelam S, Rome K. Patterns of foot complaints in systemic lupus erythematosus: a cross sectional survey. J Foot Ankle Res. 2016 Mar 22;9:10. doi: 10.1186/s13047-016-0143-8. eCollection 2016.

    PMID: 27006702RESULT

  • Reina-Bueno M, Vazquez-Bautista MDC, Perez-Garcia S, Rosende-Bautista C, Saez-Diaz A, Munuera-Martinez PV. Effectiveness of custom-made foot orthoses in patients with rheumatoid arthritis: a randomized controlled trial. Clin Rehabil. 2019 Apr;33(4):661-669. doi: 10.1177/0269215518819118. Epub 2018 Dec 17.

    PMID: 30556429RESULT

  • Reina-Bueno M, Vazquez-Bautista MDC, Palomo-Toucedo IC, Dominguez-Maldonado G, Castillo-Lopez JM, Ramos-Ortega J, Munuera-Martinez PV. Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial. BMJ Open. 2021 Mar 1;11(3):e042627. doi: 10.1136/bmjopen-2020-042627.

    PMID: 33649056DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, SystemicMusculoskeletal PainPain

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesMuscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 20, 2019

Study Start

November 2, 2019

Primary Completion

February 2, 2021

Study Completion

February 2, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations

ES(1)