Plantar FascitisTAPNCT06386406
This is a Study to Evaluate a Pre-confectioned Plantar Insole for the Treatment of Plantar Heel Pain
A study testing TAP insole in people with Plantar Fascitis, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- TAP insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Apr 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Plantar Fascitis
- Being tested
- TAP insole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP insoleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TAP insole | Experimental | Not described Receives: Device: TAP insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 2 weeks, 6 weeks,3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start23 Apr 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386406
- Sponsor's protocol ID
- ORL-ORT-040
- Acronym
- TAP
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mono-centric Clinical Investigation to Evaluate Performance of a Pre-confectioned Plantar Insole for the Treatment of Plantar Heel Pain.
- ClinicalTrials.gov ID
- NCT06386406
- Acronym / sponsor ID
- TAP / ORL-ORT-040
- Conditions
- Plantar Fascitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAP insole | Experimental | Device: TAP insole |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP insoleThe 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. | Device | TAP insole |
Primary outcome
Change in pain severity according to visual analog scale
Time frame: 3 months
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.
4 secondary outcomes
Change in pain severity according to visual analog scale
Time frame: 2 weeks, 6 weeks, 6 and 12 months.
Subjective functional recovery based on the Foot Function Index (FFI) score [
Time frame: 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)
Time frame: baseline, 2 and 6 weeks, and 3, 6, and 12 months follow-up
Patient satisfaction on a 0-10 numeric rating scale (NRS)
Time frame: 2 weeks, 6 weeks,3, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP insole in people with Plantar Fascitis, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain severity according to visual analog scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.