Last reviewed · How we verify
NCT07004543: STEP-IN
Evaluation of Toe Separators in Foot Health
NA trial testing Standard Silicone Toe Separator Application in Health-Related Behavior in 32 participants. Completed in 26 May 2025.
26 May 2025
Quick facts
| Lead sponsor | Fundación Universidad Católica de Valencia San Vicente Mártir |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 1 May 2025 |
| Primary completion | 26 May 2025 |
| Estimated completion | 26 May 2025 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Standard Silicone Toe Separator Application
Conditions studied
- Health-Related Behavior — all drugs for Health-Related Behavior →
Sponsor
Fundación Universidad Católica de Valencia San Vicente Mártir — full company profile →
Who can join
Adults 18 to 99, any sex, with Health-Related Behavior. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07004543
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07004543 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundación Universidad Católica de Valencia San Vicente Mártir
- Last refreshed: 4 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07004543.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing