Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis

Last updated: January 31, 2025
Sponsor: IR Centers
Overall Status: Active - Recruiting

Phase

N/A

Condition

Soft Tissue Infections

Treatment

Lipiodol (ethiodized oil) injection

Clinical Study ID

NCT06805942
12382
  • Ages 22-100
  • All Genders

Study Summary

This study evaluates the feasibility and safety of using Lipiodol (ethiodized oil) as an investigational embolic agent for treating pain caused by plantar fasciitis. Participants will undergo a minimally invasive procedure called plantar fascia embolization (PFE) to reduce inflammation and pain in the affected area. The study aims to assess changes in pain levels, foot function, and any potential side effects over a six-month follow-up period.

Eligibility Criteria

Inclusion

Inclusion Criteria:Participants aged 22 years or older. Diagnosed with plantar fasciitis by an orthopedic or podiatry surgeon.

Ultrasound evaluation showing:

Increased plantar fascia thickness > 4 mm. Hyperemia in the plantar fascia near its proximal insertion or perifascial soft tissue.

Self-reported pain of at least 5/10 on the Visual Analog Scale (VAS). Negative X-ray for acute fractures. Refractory to at least 6 weeks of conservative therapies. Able to provide written informed consent. -

Exclusion

Exclusion Criteria:Heel pain caused by stress fractures, nerve entrapment, or inflammatory conditions such as arthritis, gout, or bursitis.

Corticosteroid injection in the plantar fascia within 90 days prior to embolization.

Prior surgical repair or plantar fascia rupture. Severe allergy to Lipiodol or iodinated contrast media. Diagnosis of peripheral arterial disease affecting the lower extremities. Active workers' compensation claim for plantar fasciitis. Pregnancy or breastfeeding. Type 1 Diabetes Mellitus or significant renal dysfunction (GFR < 45 or serum creatinine > 2.0 mg/dL).

Sensory or motor neuropathy of the feet. Active skin wounds on the plantar surface of the affected foot.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Lipiodol (ethiodized oil) injection
Phase:
Study Start date:
February 15, 2025
Estimated Completion Date:
September 30, 2025

Study Description

This study investigates the use of Lipiodol (ethiodized oil) for plantar fascia embolization (PFE) to treat pain from plantar fasciitis. It focuses on evaluating safety, feasibility, and outcomes related to pain reduction and improved foot function.

Connect with a study center

  • IR Centers

    Falls Church, Virginia 22043
    United States

    Active - Recruiting

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