This is a Study to Evaluate a Pre-confectioned Plantar Insole for the Treatment of Plantar Heel Pain

NCT ID: NCT06386406

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-23

Study Completion Date

2026-03-31

Brief Summary

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Patients affected by plantar heel pain will be asked to use a pre-confectioned plantar insole for one year.

The aim of the study is to assess if the insole under study allows the patient to reach a better mobility and a faster return to the normal everyday life.

Detailed Description

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Conditions

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Plantar Fascitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAP insole

Group Type EXPERIMENTAL

TAP insole

Intervention Type DEVICE

The patients will have to wear the TAP insole when walking during the everyday life activities.

This plantar insole is not a custom-made insole but a pre-confectioned one because designed according to two parameters: shoe size and gender.

Interventions

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TAP insole

The patients will have to wear the TAP insole when walking during the everyday life activities.

This plantar insole is not a custom-made insole but a pre-confectioned one because designed according to two parameters: shoe size and gender.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Male and female adults

* Age ranging 18 to 70 years
* Patients with a history of at least 6 months of plantar fasciitis resistant to other conventional therapies
* Willingness and ability to participate in the trial
* Informed Consent signed by the subject

Exclusion Criteria

* Diabetes mellitus not controlled pharmacologically
* Rheumatoid arthritis
* Previous foot surgery
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ente Ospedaliero Cantonale, Bellinzona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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EOC

Lugano, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Facility Contacts

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Martin Riegger, Dr.med

Role: primary

+41 (0) 91 811 70 29

Other Identifiers

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ORL-ORT-040

Identifier Type: -

Identifier Source: org_study_id

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