Evaluation of Toe Separators in Foot Health (STEP-IN)

Fundación Universidad Católica de Valencia San Vicente Mártir

Status: Completed

Conditions: Health-Related Behavior

Treatments: Procedure: Standard Silicone Toe Separator Application

Study type: Interventional

Funder types: Other

Identifiers

NCT07004543

UCV/2023.2024/027.

Details and patient eligibility

About

This pilot observational study investigates the effects of standard toe separators on foot health in asymptomatic individuals. It aims to evaluate their impact on intermetatarsal spacing, plantar pressure distribution, digital circulation, and user comfort. Through pre- and post-intervention measurements using tools like thermography, gait analysis (Zebris), and the Foot Posture Index, the research seeks to determine whether these commonly used orthotic devices provide measurable benefits or pose risks. The study ultimately contributes to evidence-based podiatric care and public health education.

Full description

This research project titled "Evaluation of Toe Separators in Foot Health: A Pilot Observational Study (STEP-IN)" explores the biomechanical and physiological effects of standard, commercially available toe separators on healthy individuals without pre-existing podiatric conditions.

Given the growing popularity of these devices on social media and among the general public-often promoted as tools for correcting deformities, relieving plantar pain, or improving foot posture-this study aims to objectively assess their actual benefits and limitations using scientific methods.

The study employs a pre-post observational design involving 40 adult volunteers. A comprehensive analysis is conducted before and after the application of toe separators, focusing on several key variables:

Intermetatarsal angles and spacing measured through imaging (ultrasound or X-ray).

Gait and plantar pressure distribution assessed with the Zebris system.

Digital circulation evaluated visually and via thermographic imaging.

Foot posture assessed using the validated Foot Posture Index (FPI-6).

Comfort perception measured through a Visual Analog Scale (VAS).

Participants are evaluated during static stance and dynamic walking conditions to determine how the devices affect natural biomechanics. Data is analyzed statistically using SPSS and JASP to compare pre- and post-intervention results, applying appropriate tests based on normality assumptions.

Ethical approval was obtained from the Ethics Committee of the Universidad Católica de Valencia, and all participants provided informed consent.

This project aims not only to inform podiatric practice but also to serve as a foundation for future, larger-scale clinical trials. Additionally, it seeks to counteract misinformation by offering evidence-based insights into a widely used but poorly studied orthotic product.

Enrollment: 32 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult participants (without foot pathologies)
• Age 18 or older
• Voluntary participation with signed informed consent
• Students or staff from UCV clinics

Exclusion criteria

• Systemic conditions affecting foot sensitivity or circulation (e.g., Raynaud's syndrome,
• Diabetes Type I or II, post-surgical neuralgias, cerebral palsy, acquired hemiplegia, herniated discs with neural involvement, fibromyalgia)
• Presence of any diagnosed podiatric pathology
• Under 18 years of age
• Pregnant individuals
• Inability to understand or sign the informed consent form

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Standard Toe Separator Intervention

Experimental group

Description:

Participants in this arm will undergo assessments before and after using standard, non-custom silicone toe separators.

Treatment:

Procedure: Standard Silicone Toe Separator Application

No-Intervention Control Group

No Intervention group

Description:

Participants in the control arm will undergo the same evaluation procedures as the intervention group but without the application of toe separators.