RecruitingNot ApplicableNCT06805942

Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis

Sponsor

IR Centers

Enrollment

10 participants

Start Date

Feb 15, 2025

Study Type

INTERVENTIONAL

Conditions

Plantar Fasciitis of Both Feet

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

Min Age: 22 YearsMax Age: 100 Years

Inclusion Criteria3

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 Criteria4

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.
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