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 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT00189592
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of plantar fasciitis/fasciosis by all of the following:
* Tenderness with palpation and local pressure over the medial calcaneal tuberosity on passive dorsiflexion of the foot
* VAS (Visual Analog Scale) pain score of \> 5 points on a scale of 0 to 10, during the first few minutes of walking in the morning
* Ultrasound or magnetic resonance imaging (MRI) confirming plantar fasciitis/fasciosis
* Symptoms consistent with plantar fasciitis/fasciosis for at least 6 months as assessed by patient history
* Pain unresponsive to non-steroidal anti-inflammatory drugs (NSAIDs) and any four of the following conservative treatments: rest, taping, orthotics, shoe modifications, night splinting, casting, physical therapy, or local corticosteroid injections for up to 3 months
* Must be at least 18 years old and no more than 72 years old
* Must sign the Institutional Review Board (IRB) approved informed consent form
* Subject is willing and able to complete required follow-up
Exclusion Criteria:
* Body mass index (BMI) \> 40
* History or documentation showing type I and type II diabetes mellitus
* Physical findings and documentation of coagulopathy, infection, tumor or other systemic disease(s)
* History or documentation showing peripheral vascular disease or autoimmune disease
* Subject has received NSAIDs (e.g., ibuprofen, naproxen) for treatment of plantar fasciitis/fasciosis 2 weeks prior to treatment by this study
* Subject has received NSAIDs (e.g. ibuprofen, naproxen) or oral corticosteroids 2 weeks prior to treatment by this study
* Subject is receiving worker's compensation
* Subject is currently involved in litigation related to the injury being studied
* Prior surgical treatment of the plantar fascia(s) to be treated by this study
* Subject is currently participating in another drug/device study related to the injured plantar fascia
* Pregnant or pregnant suspected subjects
* Clinically significant bilateral plantar fasciitis/fasciosis with a VAS pain scale of \> 5 bilaterally
* Subject is not capable of understanding or responding to study questionnaires.
* Extracorporeal shockwave therapy (ESWT) within 6 months of study treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
72 Years
Study:
NCT00189592
Study Brief:
Protocol Section:
NCT00189592