RecruitingNot ApplicableNCT06386406

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

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


Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Enrollment

25 participants

Start Date

Apr 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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.

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Interventions

DEVICETAP 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.


Locations(1)

EOC

Lugano, Switzerland

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NCT06386406


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