10 Participants Needed

Lateral Plantar Artery Embolization for Plantar Fasciitis

LA
Overseen ByLayth Alkhani
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new procedure to determine if it can safely and effectively reduce chronic heel pain from plantar fasciitis. The treatment involves a doctor injecting a temporary blocking agent (Lipiodol) into specific blood vessels in the foot to relieve pain. The trial seeks individuals who have experienced persistent plantar fasciitis pain despite trying other treatments for at least three months and wish to avoid surgery. Participants will have follow-up calls and visits over a year to monitor their pain levels and any side effects. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative procedure.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulation therapy, you may not be eligible to participate.

What prior data suggests that this procedure is safe for treating plantar fasciitis?

Research suggests that Lipiodol, used in a procedure for heel pain, is generally well-tolerated. Past studies on Lipiodol for similar treatments showed few serious side effects. Most patients experienced mild to moderate discomfort, which was temporary. Although research is still in the early stages, evidence so far indicates that Lipiodol is safe for treating heel pain from plantar fasciitis. However, as this is a Phase 1 trial, the main goal is to assess safety, with ongoing data collection to ensure no unexpected risks arise. Researchers closely monitor participants for any side effects, prioritizing safety.12345

Why are researchers excited about this trial?

Unlike the standard treatments for plantar fasciitis, which often involve physical therapy, anti-inflammatory medications, or steroid injections, Lipiodol in lateral plantar artery embolization targets the condition via a minimally invasive procedure. This treatment is unique because it works by reducing blood flow to the affected area, which may help decrease inflammation and pain more effectively than traditional methods. Researchers are excited about this approach because it offers a new mechanism of action that could provide relief for patients who haven't responded well to conventional therapies.

What evidence suggests that this procedure is effective for plantar fasciitis?

Research has shown that embolization therapy, which uses a substance called Lipiodol, might help reduce long-term heel pain from plantar fasciitis. In this trial, participants will undergo Lateral Plantar Artery Embolization using Lipiodol. One study found that 13 patients with this condition reported satisfaction after the procedure. Another study demonstrated that using Lipiodol to block certain blood vessels is both feasible and safe for treating pain. These early results suggest that targeting specific blood vessels in the foot could effectively manage heel pain. While more research is needed, the initial findings are promising.12367

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.
See 2 more

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.
See 5 more

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?

1

Treatment groups

Experimental Treatment

Group I: Lateral Plantar Artery EmbolizationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Joint & Vascular Institute

Lead Sponsor

Citations

Lateral Plantar Artery Embolization For Plantar Fasciitis

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 ...

Early outcomes of transcatheter arterial embolization using ...

The present study reports 13 successful cases of TAE with chronic pain due to plantar fasciitis. All the patients in our study were satisfied ...

A Pilot Study Evaluating Safety and Efficacy Using Lipiodol ...

This study aims to assess the safety, efficacy, and technical feasibility of embolization using Guerbet Lipiodol (ethiodized oil) for treating pain secondary ...

NCT06805942 | Embolization for the Treatment of Heel ...

This study evaluates the feasibility and safety of using Lipiodol (ethiodized oil) as an investigational embolic agent for treating pain caused by plantar ...

Embolization for the Treatment of Heel Pain Secondary to ...

This study investigates the use of Lipiodol (ethiodized oil) for plantar fascia embolization (PFE) to treat pain from plantar fasciitis. It ...

Lateral Plantar Artery Embolization for Plantar Fasciitis

This Phase 1 medical study run by Joint & Vascular Institute is evaluating whether Lipiodol will have tolerable side effects & efficacy for ...

Abstract No. 331 Embolization for the Treatment of Heel ...

Conclusion: This pilot study aims to determine the safety and feasibility of plantar fascia embolization (PFE) using Lipiodol for. PF. It builds upon the ...