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Lateral Plantar Artery Embolization For Plantar Fasciitis

NCT07395128 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-02-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Joint & Vascular Institute

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-20
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07395128 on ClinicalTrials.gov