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Clinical Trial NCT07395128 for Plantar Fasciitis, Chronic, Plantar Fasciitis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Lateral Plantar Artery Embolization For Plantar Fasciitis Phase 1 10 Telehealth

Recruiting
Clinical Trial NCT07395128 is designed to study Device Feasibility for Plantar Fasciitis, Chronic, Plantar Fasciitis. It is a Phase 1 interventional study that is recruiting, having started on 20 December 2025, with plans to enroll 10 participants. Led by Joint & Vascular Institute, it is expected to complete by 1 March 2027. The latest data from ClinicalTrials.gov was last updated on 9 February 2026.
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 freq...

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Official Title

Lateral Plantar Artery Embolization to Treat Pain Chronic Heel Pain Due To Plantar Fasciitis A Pilot Study to Assess Feasibility

Conditions
Plantar Fasciitis, ChronicPlantar Fasciitis
Other Study IDs
  • 1402856
NCT ID Number
NCT07395128
Start Date (Actual)
2025-12-20
Last Update Posted
2026-02-09
Completion Date (Estimated)
2027-03
Enrollment (Estimated)
10
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
plantar fasciitis
Primary Purpose
Device Feasibility
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalLateral Plantar Artery Embolization
Lipiodol
Participants will receive a transcatheter arterial embolization of the lateral plantar artery branches. The intervention involves the selective catheterization of the calcaneal branches under fluoroscopic guidance using a microcatheter. A mixture of Lipiodol (a transient liquid embolic agent) and iodinated contrast media is injected until an endpoint of "near stasis" is reached. A maximum of 5 mL of Lipiodol will be ...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Pain Change
Pain - measured via VAS at baseline, 1-month, 3-month, 6-month, and 12-month follow-up
Baseline to 12 months
Safety (rate of adverse events)
Safety - Percentage of subjects without serious adverse events related to the medical device
Baseline to 12 month follow-up
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
25 Years
Eligible Sexes
All
  • 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

  • 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
Joint & Vascular Institute logoJoint & Vascular Institute
Study Central Contact
Contact: Layth Alkhani, 847-584-3959, [email protected]
1 Study Locations in 1 Countries

Illinois

Joint and Vascular Institute, Libertyville, Illinois, 60048, United States
Layth Alkhani, Contact, 847-584-3959, [email protected]
Recruiting