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:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2025-12-25 @ 3:17 AM
NCT ID:
NCT05075005
Eligibility Criteria:
Inclusion Criteria for Group A:
* Patients presenting to the University of Florida Orthopaedics and Sports Medicine Institute with pain on the plantar medial or central heel for greater than 60 days with the following features
* Pain upon palpation, or insidious pain onset
* Pain accentuated after long periods of weight bearing activities or after periods of rest
* A reduction in pain following light activities (McPoil et al., 2008)
* Failure to respond to treatment modalities for 6 months, including plantar fascia and muscle stretching, nonsteroidal anti-inflammatory medication, supportive insoles, and night splints
* Age \>18 years
Inclusion Criteria for Group B:
* Healthy individuals in the general population of Gainesville and surrounding areas
* Age \>18
Exclusion Criteria for Group A:
* History of lower leg or foot surgery, hindfoot trauma or fracture of the affected limb within the previous year.
* Diagnosis of diabetic neuropathy, fibromyalgia, neurological disease, Achilles tendinopathy, metatarsalgia, tarsal tunnel syndrome or heel pad syndrome
* Body Mass Index (BMI) \> 35
* Currently taking or applying any anti-inflammatory medication or medication to control nerve pathology, prescription or over the counter
* Third trimester pregnancy
Exclusion Criteria for Group B:
* Any foot or lower limb pathology resulting in discomfort or gait limitation
* Diagnosis of diabetic neuropathy, fibromyalgia, neurological disease
* BMI \>35
* Currently taking or applying any anti-inflammatory medication or medication to control nerve pathology, prescription or over the counter
* Third trimester pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05075005
Study Brief:
Protocol Section:
NCT05075005