NCT07395128

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
10mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Dec 2025Mar 2027

Study Start

First participant enrolled

December 20, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 24, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

January 24, 2026

Last Update Submit

February 5, 2026

Conditions

Plantar Fasciitis, ChronicPlantar Fasciitis

Keywords

plantar fasciitis

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Lateral Plantar Artery Embolization

EXPERIMENTAL
Device: Lipiodol

Interventions

LipiodolDEVICE

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.

Lateral Plantar Artery Embolization

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joint and Vascular Institute

Libertyville, Illinois, 60048, United States

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Central Study Contacts

Layth Alkhani

CONTACT

847-584-3959lalkhani@jointvascular.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2026

First Posted

February 9, 2026

Study Start

December 20, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

US(1)