Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis

IR Centers10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Plantar Fasciitis of Both Feet

Interventions

Lipiodol (ethiodized oil) injectionDEVICE

Lipiodol will be used as an embolic agent for arterial embolization targeting neovascularity in the plantar fascia to reduce inflammation and pain.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 100 Years

Medical Language ↔ Plain English

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. \-

Locations (1)

IR Centers

Falls Church, Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

Reduction in Pain (VAS Score)

Change in pain level as measured by the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable).

Time frame: Baseline to 6 months

Secondary Outcomes

Improvement in Foot Function (FAAM Score)

Change in function as assessed by the Foot and Ankle Ability Measure (FAAM), including activities of daily living and sports subscales.

Time frame: Baseline to 6 months

Central Contacts

Sindhuja Kommidi Clinical Research Coordinator, MS

CONTACT

7327831259 sindhu@ircenters.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.