NCT07395128

Lateral Plantar Artery Embolization For Plantar Fasciitis

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Joint & Vascular Institute · Industry
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plantar Fasciitis, Chronic
• Plantar Fasciitis

Interventions

Type	Name	Description
DEVICE	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 used per procedure. This intervention specifically targets the hypervascularity (neovascularization) associated with chronic plantar fasciitis to alleviate pain and reduce inflammation.

Timeline

• Start date: 2025-12-20
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study