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 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT03231150
Eligibility Criteria:
Inclusion Criteria:
* Pain on palpation along the proximal plantar fascia with or without radiographic evidence of a plantar calcaneal bone spur
* ≥18 years of age
* Male or non-pregnant female of any ethnicity or race
* Active, former or non smoker
* With or without peripheral vascular disease without lower extremity intermittent claudication or rest pain
* With or without diabetes mellitus without polyneuropathy
* With or without collagen vascular disease without lower extremity wound formation.
Exclusion Criteria:
* Known drug or alcohol dependence
* Chronic pain syndrome or lumbosacral radiculitis
* Neurological condition that requires the use of analgesic medications or anti-seizure or neuroleptic medications
* Peripheral vascular disease that results in rest pain or intermittent claudication or venous stasis ulceration
* Calcaneal stress fracture or show evidence of a foreign body or tumor of the affected heel as viewed radiographically
* Pregnant females
* Known allergy to any of the components of the injection therapy
* Previously suffered a rupture or surgery of the plantar fascia within the 5 years preceding participation in the investigation
* Existing or prior osteomyelitis of the involved calcaneus
* Unable to consent to participation in clinical research or currently be involved in another clinical investigation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03231150
Study Brief:
Protocol Section:
NCT03231150