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Completed

NCT Number: NCT07004543

Evaluation of Toe Separators in Foot Health

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.

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Key information

Conditions

Health-Related Behavior Behavior Health Behavior

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinicas UCV

Valencia, València, 46001, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Silicone Toe Separator Application

Procedure

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.

Primary outcomes

  1. Plantar Pressure Distribution

    Time frame: Baseline and immediately post-intervention

    Zebris treadmill analysis

Secondary outcomes

  1. Intermetatarsal Angles (2nd-3rd, 3rd-4th, 4th-5th)

    Time frame: Baseline and immediately post-intervention

    Imaging (X-ray)

  2. Intermetatarsal Spaces

    Time frame: Baseline and immediately post-intervention

    Quantitative (millimeters)Imaging (X-ray)

  3. Gait Parameters

    Time frame: Baseline and immediately post-intervention

    Zebris gait analysis system

  4. Foot Posture Index

    Time frame: Baseline and immediately post-intervention

    Foot Posture Index (FPI-6).is a clinical tool used to evaluate foot posture in the standing position, taking into account six visual criteria. Each is scored between -2 and +2, giving a total score ranging from -12 (very supinated foot) to +12 (very pronated foot).

    Score range: -12 (maximum supination) to +12 (maximum pronation).

    Interpretation of scores:

    Lower scores indicate a more supinated (less pronated) foot posture. Higher scores indicate a more pronated (less supinated) foot posture.

  5. Perceived Comfort

    Time frame: Baseline and immediately post-intervention

    After the toe separators are applied, the participant will be shown a 10-point Likert-type scale, included in the data collection sheet. It will be explained that they should indicate the degree of comfort they feel while wearing the toe separators by choosing a number from 1 to 10, where:

    1 means very uncomfortable

    10 means very comfortable

    The participant should select the number that best reflects their subjective perception of comfort at that moment.

  6. Digital Circulation

    Time frame: Baseline and immediately post-intervention

    A visual inspection of the participant's feet will be performed to identify any noticeable changes in skin color, swelling, alignment or other external signs of alteration.

  7. Digital Circulation

    Time frame: Baseline and immediately post-intervention

    Thermographic imaging.will be used to assess thermal patterns and skin temperature distribution across the feet. Images will be captured using an infrared thermal camera under standardized environmental conditions.

Sponsors and collaborators

Lead sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Other

Registry information

Official study title

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

Acronym: STEP-IN

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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