Actively Recruiting
A Clinical Investigation to Evaluate a Pre-confectioned Plantar Insole for Treating Plantar Heel Pain
Led by Ente Ospedaliero Cantonale, Bellinzona · Updated on 2025-08-06
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of a pre-confectioned plantar insole for adults with plantar heel pain, specifically those with plantar fasciitis lasting at least six months and resistant to conventional treatments. The study seeks to determine whether this insole helps improve mobility and speeds up the return to normal daily activities. The investigation is conducted by Ente Ospedaliero Cantonale, Bellinzona and does not involve blinding or placebo control. Participants will use the TAP insole, a device designed based on shoe size and gender rather than custom-made, during everyday walking activities for one year. The insole is studied to assess its performance in relieving pain and improving foot function over time. During the study, participants will be monitored at multiple time points up to 12 months. Researchers will measure changes in pain severity using a visual analog scale, functional recovery through the Foot Function Index, quality of life via the Foot Health Status Questionnaire, and patient satisfaction on a numeric rating scale. These assessments will help understand the insole’s impact on foot health and mobility.
CONDITIONS
Brief Title
This is a Study to Evaluate a Pre-confectioned Plantar Insole for the Treatment of Plantar Heel Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Diabetes mellitus not controlled pharmacologically
- Rheumatoid arthritis
- Previous foot surgery
- Inability to follow the procedures of the study due to language problems, psychological disorders, dementia, or general physical problems
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants wear the TAP insole when walking during everyday life activities to treat plantar heel pain.
Visits at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
EOC
Lugano, Switzerland, 6900
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here