Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
NCT ID:
NCT05370092
Eligibility Criteria:
Inclusion Criteria:
* Subjects over 18 years of age
* Mild inflammation, swelling and/or tenderness posterior to the medial malleolus
* Pain posterior and/or superior to the medial malleolus, aggravated by activity
* Pain present for at least 3 months
* One or more signs of flexible flatfoot deformity, including excessive valgus deformity of the hindfoot during weight bearing and/or excessive foot abduction (many toes sign).
* Pain when performing the Hell Rise Test or performed incorrectly.
* Signs of tenosynovitis on ultrasound examination.
As the inclusion criteria are based on side-to-side comparison all participants had to have unilateral involvement.
Exclusion Criteria:
* Previous surgery on the affected foot, leg or knee.
* Disabling osteoarthritis of the knee on the affected side.
* Fixed hindfoot deformities.
* Recurrent ankle sprains on the affected side.
* Ligament tears or bony abnormalities of the affected foot.
* A physical or medical condition that contraindicates the testing protocol.
* Pregnancy.
* FCD or FLH tendinopathy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05370092
Study Brief:
Protocol Section:
NCT05370092