Evaluating a special insole for treating plantar heel pain
A Mono-centric Clinical Investigation to Evaluate Performance of a Pre-confectioned Plantar Insole for the Treatment of Plantar Heel Pain.
This study is testing a special insole to see if it helps adults with plantar fasciitis feel less pain and get back to their daily activities faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 1 site (Lugano) |
| Trial ID | NCT06386406 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a pre-confectioned plantar insole in patients suffering from plantar fasciitis. Participants will use the insole for one year to determine if it improves mobility and facilitates a quicker return to normal daily activities. The study aims to gather data on the insole's impact on pain relief and functional improvement in affected individuals. It includes adults aged 18 to 70 with a history of plantar fasciitis that has not responded to conventional treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a history of plantar fasciitis resistant to other therapies.
Not a fit: Patients with uncontrolled diabetes, rheumatoid arthritis, or those who have had previous foot surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for patients suffering from chronic plantar heel pain.
How similar studies have performed: While there may be studies on insoles for plantar fasciitis, the specific approach of this pre-confectioned insole is novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lugano
- Eoc — Lugano, Switzerland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.