NCT07395128 Lateral Plantar Artery Embolization For Plantar Fasciitis
| NCT ID | NCT07395128 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Joint & Vascular Institute |
| Condition | Plantar Fasciitis, Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-12-20 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-12-20 with a primary completion date of 2027-03.
⚠ 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 goal of this clinical trial is to learn if lateral plantar artery embolization using Lipiodol can safely and effectively treat chronic heel pain due to plantar fasciitis in adults aged 25 to 80. The main questions it aims to answer are: Does this procedure successfully reduce chronic heel pain as measured by the Visual Analog Scale (VAS) over 12 months? How safe is the procedure, specifically regarding the frequency of serious medical problems or adverse events related to the device? Participants will: Undergo a minimally invasive procedure where a doctor uses a small tube (catheter) to inject a temporary blocking agent (LipioJoint) into specific blood vessels in the foot. Receive a phone call one day after the procedure to check for early side effects. Participate in four follow-up telehealth visits over the course of one year (at 1, 3, 6, and 12 months). Complete pain intensity surveys (VAS) and report any changes in their use of other therapies or medications during these visits.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 25 years * Subject provides written informed consent * Patient with Plantar Fasciitis refractory to 3 months of conservative management * Self reported pain of at least 4/10 on visual analog scale (VAS) * Non-surgical candidate/looking to avoid surgery Exclusion Criteria: * Heel pain caused by acute fracture, recent trauma, inflammatory conditions, muscle/ligament injury, and etiologies related to bone mineral density. * Steroid injection in the last 90 days from the embolization procedure * Known severe allergy to Lipiodol and/or iodinated contrast media * Diagnosis of peripheral arterial disease affecting the lower extremities * Pregnancy or breastfeeding * Anticoagulation or irreversible coagulopathy * GFR \<45 or Serum creatinine \> 2.0 mg/dl * Type 1 Diabetes Mellitus
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07395128 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 80 Years, studying Plantar Fasciitis, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07395128 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07395128 currently recruiting?
Yes, NCT07395128 is actively recruiting participants. Contact the research team at lalkhani@jointvascular.com for enrollment information.
Where is the NCT07395128 trial being conducted?
This trial is being conducted at Libertyville, United States.
Who is sponsoring the NCT07395128 clinical trial?
NCT07395128 is sponsored by Joint & Vascular Institute. The trial plans to enroll 10 participants.