Actively Recruiting

Phase 1
Age: 25Years - 80Years
All Genders
ID07395128

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

Led by Joint & Vascular Institute · Updated on 2026-02-09

10

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating if lateral plantar artery embolization using Lipiodol can safely and effectively treat chronic heel pain caused by plantar fasciitis in adults aged 25 to 80. This pilot study aims to determine whether this minimally invasive procedure can reduce pain over 12 months and assess the safety by monitoring serious medical problems or adverse events related to the device. Participants will undergo a procedure where a doctor inserts a small tube (catheter) to inject Lipiodol, a temporary blocking agent, into specific blood vessels in the foot. The procedure targets branches of the lateral plantar artery associated with increased blood vessel growth linked to chronic plantar fasciitis. The injection is guided by imaging and uses up to 5 mL of Lipiodol to reduce pain and inflammation. After the procedure, participants will receive a phone call the next day to check for early side effects. They will then take part in four telehealth follow-up visits at 1, 3, 6, and 12 months, during which they will complete pain surveys using the Visual Analog Scale (VAS) and report any changes in other treatments or medications. Researchers will monitor pain changes and safety outcomes throughout the year-long study.

CONDITIONS

Brief Title

Lateral Plantar Artery Embolization For Plantar Fasciitis

Who Can Participate

Age: 25Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 25 years or older
  • Provide written informed consent
  • Diagnosis of plantar fasciitis not improved after 3 months of conservative treatment
  • Self-reported heel pain of 4 or higher on the Visual Analog Scale (VAS)
  • Not a candidate for surgery or seeking to avoid surgery
Not Eligible

You will not qualify if you...

  • Heel pain caused by acute fracture, recent injury, inflammatory conditions, muscle or ligament injury, or bone density issues
  • Steroid injection in the heel within 90 days before the procedure
  • Known severe allergy to Lipiodol or iodinated contrast media
  • Diagnosis of peripheral arterial disease in the lower limbs
  • Pregnancy or breastfeeding
  • Currently on anticoagulation or have irreversible blood clotting disorders
  • Kidney function with GFR less than 45 or serum creatinine over 2.0 mg/dl
  • Type 1 Diabetes Mellitus

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 day

Participants receive a transcatheter arterial embolization of the lateral plantar artery branches using a device to reduce pain and inflammation associated with plantar fasciitis.

1 procedure visit (in-person)

Long-term Monitoring

Duration - 12 months

Participants are monitored for pain changes and safety outcomes following the embolization procedure.

Follow-up visits over 12 months

Trial Site Locations

Total: 1 location

1

Joint and Vascular Institute

Libertyville, Illinois, United States, 60048

Actively Recruiting

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Research Team

L

Layth Alkhani

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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