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

Ente Ospedaliero Cantonale, Bellinzona

Status: Enrolling

Conditions: Plantar Fascitis

Treatments: Device: TAP insole

Study type: Interventional

Funder types: Other

Identifiers

NCT06386406

ORL-ORT-040

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

TAP insole

Experimental group

Treatment:

Device: TAP insole