NCT03231150 Plantar Fasciitis Randomized Clinical Control Trial
| NCT ID | NCT03231150 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Plantar Fascitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2017-03-28 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2017-03-28 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary aim of this clinical experiment is to compare, in terms of pain relief measured using the 10-cm visual analog scale (VAS) pain score (5-7), the clinical results of ultrasound-guided injection (USGI) versus anatomic topography-guided injection (ATGI) of corticosteroid for the treatment of proximal PF. Secondary aims will be to compare foot-related quality of life, as measured using the Foot Function Index (FFI)and the Bristol Foot Score (BFS), between the injection groups, and also to compare the pre-injection to late-term post-injection thickness of the plantar fascia as measured in the nested USGI group.
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.
Contact & Investigator
Donald S Malay, DPM
PRINCIPAL INVESTIGATOR
Penn Presbyterian Medical Center
Frequently Asked Questions
Who can join the NCT03231150 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Plantar Fascitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03231150 currently recruiting?
Yes, NCT03231150 is actively recruiting participants. Contact the research team at malaydsm@gmail.com for enrollment information.
Where is the NCT03231150 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT03231150 clinical trial?
NCT03231150 is sponsored by University of Pennsylvania. The principal investigator is Donald S Malay, DPM at Penn Presbyterian Medical Center. The trial plans to enroll 62 participants.