NCT07004543

Evaluation of Toe Separators in Foot Health

Evaluation of Toe Separators in Foot Health: A Pilot Observational Study (STEP-IN)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Health-Related Behavior

Interventions

Type	Name	Description
PROCEDURE	Standard Silicone Toe Separator Application	Participants will be instructed to wear standard, commercially available silicone toe separators during a single evaluation session. The intervention consists of applying the separators between the toes while the participant is barefoot, both in static standing and while walking on a treadmill equipped with a Zebris pressure analysis system. Measurements will be taken immediately before and after the application, including plantar pressure distribution, intermetatarsal spacing (via imaging), digital circulation (via thermography and visual assessment), foot posture (using the Foot Posture Index - FPI-6), and subjective comfort levels (via Visual Analog Scale). The toe separators are not customized and reflect common consumer-grade devices marketed for podiatric or wellness purposes.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-05-26
• Completion: 2025-05-26
• First posted: 2025-06-04
• Last updated: 2025-06-04

Locations

1 site across 1 country: Spain