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NCT06805942NARecruiting

Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis

IR Centers

Start Date

2/15/2025

Completion Date

9/30/2025

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.

Detailed 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.

Eligibility Criteria

Age Range: 22 years to 100 years

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 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. \-

Interventions

DEVICE

Lipiodol (ethiodized oil) injection

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Conditions

Plantar Fasciitis of Both Feet

Locations

IR Centers

Falls Church, Virginia 22043

United States