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

NCT06386406 | Recruiting

• 1 other identifier: ORL-ORT-040
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plantar Fascitis

Outcome Measures

Primary Outcomes (1)

• Change in pain severity according to visual analog scale

  The pain visual analog scale (VAS) is a validated, self-assessment scale in which patients rate their pain by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The pain VAS will be administered at baseline by the patient himself and at follow-ups. A negative change from baseline will indicate an improvement in VAS score and, therefore, in local pain.

  3 months

Secondary Outcomes (4)

• Change in pain severity according to visual analog scale

  2 weeks, 6 weeks, 6 and 12 months.

• Subjective functional recovery based on the Foot Function Index (FFI) score [

  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)

  baseline, 2 and 6 weeks, and 3, 6, and 12 months follow-up

• Patient satisfaction on a 0-10 numeric rating scale (NRS)

  2 weeks, 6 weeks,3, 6, and 12 months

Study Arms (1)

TAP insole

EXPERIMENTAL

Device: TAP insole

Interventions

TAP insole 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.

TAP insole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (1)

EOC

Lugano, 6900, Switzerland

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: April 23, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-04

Locations

CH (1)