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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Plantar Fascitis
• Intervention / Treatment: Device: TAP insole

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lugano, Switzerland, 6900
    • Recruiting
    • EOC
    • Contact: Martin Riegger, Dr.med; Phone Number: +41 (0) 91 811 70 29; Email: RicercaOrtopedia.ORL@eoc.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAP insole	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain severity according to visual analog scale	The pain VAS scale 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.	2 weeks, 6 weeks, 6 and 12 months.
Subjective functional recovery based on the Foot Function Index (FFI) score [	Foot function Index measures the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales. The patient will answer each question on a scale from 0 (best) to 10 (worst result), that best describes their foot over the past week. The pain subcategory consists of 9 items and measures foot pain in different situations. The disability subcategory consists of 9 items and measures difficulty performing functional activities because of foot problems. The activity limitation subcategory consists of 5 items and measures limitations in activities because of foot problems. Both total and subcategory scores are calculated.	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)	The Foot Health Status Questionnaire (FHSQ) is a self-assessment and trustworthy instrument about health quality regarding specific foot health, initially developed to assess the results of surgical treatment of common foot diseases. It is made of questions regarding foot health and its impact on quality of life. There are 4 subscales: foot pain (4 questions), foot function (4 questions), footwear (3 questions), and general foot health (2 questions). For the subscales of pain, function, and general foot health, there is a 5-point Likert scale of no problems, pain, or limitations to severe problems, pain, or limitations. Responses to footwear questions are on a 5-point bipolar Likert scale from strongly disagree to strongly agree for statements regarding shoe fit, discomfort wearing shoes, and shoe wear available.	baseline, 2 and 6 weeks, and 3, 6, and 12 months follow-up
Patient satisfaction on a 0-10 numeric rating scale (NRS)	self-assessment scale in which patients rate their satisfaction by making a handwritten mark from the lowest satisfaction (0 point) to the highest satisfaction (10 points)	2 weeks, 6 weeks,3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Cantonale, Bellinzona

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: ORL-ORT-040

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No