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The effectiveness of a custom-made toe crest in reducing tiptoe pain in patients with lesser toe deformities

The effectiveness of a custom-made toe crest in reducing tiptoe pain in patients with lesser toe deformities

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250404004
Enrollment
17
Registered
2025-04-04
Start date
2025-04-30
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lesser toe deformities claw toe, hammer toe, foot deformities, foot orthoses, pain, tiptoe pressure, toe crest, foot function index

Interventions

Custom-made toe crest made by an orthotist. The devices covered one-third to two-thirds of the toe length, elevating the tiptoe by 3 mm. To make the device, plastic wrap was applied over the target to
Experimental Device
custom-made toe crest

Sponsors

Research department, faculty of medicine Siriraj hospital, Mahidol university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Presence of a lesser toe deformity, specifically hammer toe or claw toe, that does not meet the criteria for surgical intervention or for which the participant has declined surgical treatment. 2.Aged 40 years or older. 3.Experiencing pain at the tip of the deformed toe for at least two weeks, with a pain level of 5 or more (assessed using the Numeric Rating Scale 0-10). If the participant has multiple deformed toes, the most painful one will be selected for the study. 4.Willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Presence of foot numbness or foot ulcers. 2. Acute inflammation of the toe joints. 3. Anticipated engagement in activities during the study period that may significantly increase walking distance, such as planned travel. 4. Inability to communicate or report pain levels. 5. Presence of acute or chronic peripheral arterial disease. 6. History of allergy or irritation to materials such as leather, tanning agents, elastic bandages, or silicone.

Design outcomes

Primary

MeasureTime frame
Pain at tip toe at 3 weeks after device usage Numeric rating scale 0-10

Secondary

MeasureTime frame
Pressure at tip toe before usage and during usage of custom made toe crest peak pressure,Complication 3 weeks after usage of custom made toe crest Log book,Compliance 3 weeks after usage of custom made toe crest Log book,Foot function 3 weeks after usage of custom made toe crest Questionnaire (FFI-TH)),Satisfaction 3 weeks after usage of custom made toe crest case record form

Countries

Thailand

Contacts

Public ContactNavaporn Chadchavalpanichaya

Mahidol University

drnavaporn@gmail.com0812978746

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026