Lateral Plantar Artery Embolization for Plantar Fasciitis

Overseen By Layth Alkhani

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Joint & Vascular Institute

Must not be taking: Anticoagulants, Steroids

Disqualifiers: Recent trauma, Peripheral arterial disease, Pregnancy, Type 1 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults aged 25 to 80 with chronic heel pain from plantar fasciitis, who haven't improved after 3 months of standard treatments and want to avoid surgery. They must be able to give informed consent and report a pain level of at least 4/10.

Inclusion Criteria

Subject provides written informed consent

My foot pain hasn't improved after 3 months of basic treatments.

I am 25 years old or older.

Exclusion Criteria

My heel pain is due to a recent injury or fracture.

I am on blood thinners or have a bleeding disorder that cannot be reversed.

My kidney function is low.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants 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

1 day

1 visit (in-person)

Immediate Follow-up

Participants receive a phone call one day after the procedure to check for early side effects

1 day

1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with telehealth visits at 1, 3, 6, and 12 months

12 months

4 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Lipiodol

Trial Overview

The study tests if injecting Lipiodol into the lateral plantar artery can reduce heel pain over a year. Participants will have one minimally invasive procedure followed by telehealth check-ins at specific intervals to monitor their pain levels.

How Is the Trial Designed?

Group I: Lateral Plantar Artery Embolization Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Joint & Vascular Institute

Lead Sponsor