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Recruiting NCT06386406

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

No phase Interventional Plantar Fascitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TAP insole.
Who it may be relevant to
Registry conditions: Plantar Fascitis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Mono-centric Clinical Investigation to Evaluate Performance of a Pre-confectioned Plantar Insole for the Treatment of Plantar Heel Pain.

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • Change in pain severity according to visual analog scale [Time frame: 3 months]
Secondary outcome measures (4)
  • Change in pain severity according to visual analog scale [Time frame: 2 weeks, 6 weeks, 6 and 12 months.]
  • Subjective functional recovery based on the Foot Function Index (FFI) score [ [Time frame: baseline, 2 and 6 weeks, and 3, 6, and 12 months]
  • Quality of life and foot general health through the assessment of the Foot Health Status Questionnaire (FHSQ) [Time frame: baseline, 2 and 6 weeks, and 3, 6, and 12 months follow-up]
  • Patient satisfaction on a 0-10 numeric rating scale (NRS) [Time frame: 2 weeks, 6 weeks,3, 6, and 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • EOC — Lugano

Identifiers

NCT: NCT06386406 · ORL-ORT-040

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗