Lupus Erythematosus, SystemicEISLENCT04098055
Effect of Insoles in Patients With Systemic Lupus Erythematosus
A study testing Custom-Made Foot Orthoses in people with Lupus Erythematosus, Systemic and Foot Orthoses, run by University of Seville at 1 site in Spain.
Trial summary
Demonstrate that custom-made insoles improve painful symptomatology, health and foot function in subjects with SLE and podiatric involvement. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Erythematosus, Systemic, Foot Orthoses, Musculoskeletal Pain
- What is being tested?
- Custom-Made Foot Orthoses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 2 Nov 2019to 2 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or more.
- Medical diagnosis of LES.
- Foot involvement.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Custom-Made Foot Orthoses, Placebo
- Keywords
- Lupus Erythematosus, Systemic, Foot Orthoses, Foot, Pain
- Medical subject headings
- Lupus Erythematosus, Systemic, Musculoskeletal Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDevice
The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam.
| Study group | Role | What they receive |
|---|---|---|
| Custom-made foot orthoses | Experimental | Not described Receives: Device: Custom-Made Foot Orthoses |
| Control Group | Placebo comparator | Not described Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
11-point Numeric Pain Rating Scale
With a range of 0 = no pain to 10 = pain as bad as it can be.
Measured: 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.
Measured: 10 minutes
Foot Function
Foot Function Index
Measured: 5 minutes
Foot Disability
Manchester Foot Pain and Disability Index
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start2 Nov 2019
- Primary completion2 Feb 2021
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro V. Munuera-Martínez, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098055
- Sponsor's protocol ID
- SLE
- Acronym
- EISLE
- Status last verified
- May 2022
- First submitted
- 18 Sep 2019
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19013374Otter 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.
PubMed 27006702Reina-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.
PubMed 30556429Reina-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.
PubMed 33649056
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Custom-made Foot Orthoses in Patients With Systemic Lupus Erythematous
- ClinicalTrials.gov ID
- NCT04098055
- Acronym / sponsor ID
- EISLE / SLE
- Keywords
- Lupus Erythematosus, Systemic, Foot Orthoses, Foot, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 2 Nov 2019 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demonstrate that custom-made insoles improve painful symptomatology, health and foot function in subjects with SLE and podiatric involvement.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custom-made foot orthoses | Experimental | Device: Custom-Made Foot Orthoses |
| Control Group | Placebo comparator | Device: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or more.
- Medical diagnosis of LES.
- Foot involvement.
Key exclusion criteria (8 listed)
- Treatment with foot orthoses.
- LES with acute symptomatic flare.
- Ulcers.
- Skin involvement.
- Neurological problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom-Made Foot OrthosesThe 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. | Device | Custom-made foot orthoses |
| PlaceboThe insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam. | Device | Control Group |
Primary outcome
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.
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.
Foot Function
Time frame: 5 minutes
Foot Function Index
Foot Disability
Time frame: 5 minutes
Manchester Foot Pain and Disability Index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Results publication: PubMed 19013374Pipili 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.
- Results publication: PubMed 27006702Otter 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.
- Results publication: PubMed 30556429Reina-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.
- Derived from this study: PubMed 33649056Reina-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom-Made Foot Orthoses in people with Lupus Erythematosus, Systemic and Foot Orthoses, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
11-point Numeric Pain Rating Scale (time frame: 1 minute). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04098055, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.