Trials / Completed
CompletedNCT04098055
Effect of Insoles in Patients With Systemic Lupus Erythematosus
Effectiveness of Custom-made Foot Orthoses in Patients With Systemic Lupus Erythematous
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- University of Seville · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Demonstrate that custom-made insoles improve painful symptomatology, health and foot function in subjects with SLE and podiatric involvement.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DEVICE | Placebo | The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam. |
Timeline
- Start date
- 2019-11-02
- Primary completion
- 2021-02-02
- Completion
- 2022-02-02
- First posted
- 2019-09-20
- Last updated
- 2022-05-19
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT04098055. Inclusion in this directory is not an endorsement.