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Health-Related BehaviorSTEP-INNCT07004543

Evaluation of Toe Separators in Foot Health

A study testing Standard Silicone Toe Separator Application in people with Health-Related Behavior, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Health-Related Behavior
What is being tested?
Standard Silicone Toe Separator Application
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSpain
Study dates
1 May 2025to 26 May 2025
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 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Spain1 site

  • Clinicas UCV

    Valencia, València, 46001

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Standard Silicone Toe Separator Application
Keywords
Toe separators, Gait analysis, Plantar pressure
Medical subject headings
Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Silicone Toe Separator ApplicationProcedure or surgery

    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.

Study groups in NCT07004543
Study groupRoleWhat they receive
Standard Toe Separator InterventionExperimentalParticipants in this arm will undergo assessments before and after using standard, non-custom silicone toe separators.
Receives: Procedure: Standard Silicone Toe Separator Application
No-Intervention Control GroupNo interventionParticipants in the control arm will undergo the same evaluation procedures as the intervention group but without the application of toe separators.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plantar Pressure Distribution

    Zebris treadmill analysis

    Measured: Baseline and immediately post-intervention

Secondary outcomes (7)

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

    Imaging (X-ray)

    Measured: Baseline and immediately post-intervention

  2. Intermetatarsal Spaces

    Quantitative (millimeters)Imaging (X-ray)

    Measured: Baseline and immediately post-intervention

  3. Gait Parameters

    Zebris gait analysis system

    Measured: Baseline and immediately post-intervention

  4. Foot Posture Index

    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.

    Measured: Baseline and immediately post-intervention

  5. Perceived Comfort

    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.

    Measured: Baseline and immediately post-intervention

  6. Digital Circulation

    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.

    Measured: Baseline and immediately post-intervention

  7. Digital Circulation

    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.

    Measured: Baseline and immediately post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2025
  2. Study start1 May 2025
  3. Primary completion26 May 2025
  4. Study completion26 May 2025

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
This research follows a single-group pre-post design, also classified as a pre-experimental model. It is a pilot observational study aimed at exploring the initial effects of standard toe separators on foot health in healthy individuals. No control group is included, as the main objective is to conduct an early investigation of the biomechanical and physiological impact of these orthotic devices. This design allows the detection of potential trends or preliminary effects, serving as a basis for future, more rigorous studies such as randomized controlled trials. Measurements are taken at two time points: Pre-intervention: Baseline evaluation without the toe separators. Post-intervention: Evaluation after applying the toe separators. This model is appropriate for exploratory phases, especially when the phenomenon under investigation-such as the widespread use of standard toe separators-has limited scientific literature and lacks empirical validation.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07004543
Sponsor's protocol ID
UCV/2023.2024/027.
Acronym
STEP-IN
Status last verified
May 2025
First submitted
9 May 2025
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The results of this study will be shared through multiple dissemination channels to ensure transparency and accessibility. Upon completion and analysis, findings will be submitted for publication in a peer-reviewed journal specializing in podiatry, biomechanics, or rehabilitation sciences. Additionally, results will be presented at relevant national and international conferences in the fields of podiatry and physical therapy.

Publications

  • Abdalbary SA. Foot Mobilization and Exercise Program Combined with Toe Separator Improves Outcomes in Women with Moderate Hallux Valgus at 1-Year Follow-up A Randomized Clinical Trial. J Am Podiatr Med Assoc. 2018 Nov;108(6):478-486. doi: 10.7547/17-026. Epub 2018 Apr 23.

    PubMed 29683337

  • Dissaneewate T, Na Rungsri T, Cheunchokasan P, Leelasamran W. Comparison between the plantar pressure effects of toe separators and insoles in patients with hallux valgus at a one-month follow-up. Foot Ankle Surg. 2022 Jan;28(1):93-99. doi: 10.1016/j.fas.2021.02.005. Epub 2021 Feb 12.

    PubMed 33612377

  • Krzesniak H, Truszczynska-Baszak A. Toe Separators as a Therapeutic Tool in Physiotherapy-A Systematic Review. J Clin Med. 2024 Dec 19;13(24):7771. doi: 10.3390/jcm13247771.

    PubMed 39768694

Questions about this trial

What is this clinical trial studying?

A study testing Standard Silicone Toe Separator Application in people with Health-Related Behavior, run by Fundación Universidad Católica de Valencia San Vicente Mártir 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 4 inclusion and 6 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 4 Jun 2025. 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. 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?

Plantar Pressure Distribution (time frame: Baseline and immediately post-intervention). 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 NCT07004543, which also lists 3 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 4 Jun 2025.

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