Actively Recruiting

Phase Not Applicable
Age: 22Years - 100Years
All Genders
NCT06805942

Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis

Led by IR Centers · Updated on 2025-02-03

10

Participants Needed

1

Research Sites

32 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis

Who Can Participate

Age: 22Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 22 years or older
  • Diagnosed with plantar fasciitis by an orthopedic or podiatry surgeon
  • Ultrasound showing plantar fascia thickness greater than 4 mm
  • Ultrasound showing increased blood flow near the plantar fascia's proximal insertion or surrounding soft tissue
  • Self-reported pain of at least 5 out of 10 on the Visual Analog Scale
  • Negative X-ray for acute fractures
  • Pain resistant to at least 6 weeks of conservative treatments
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • 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 before embolization
  • Prior surgery or rupture of the plantar fascia
  • Severe allergy to Lipiodol or iodinated contrast media
  • Peripheral arterial disease affecting the lower legs
  • Active workers' compensation claim for plantar fasciitis
  • Pregnancy or breastfeeding
  • Type 1 Diabetes Mellitus or serious kidney problems (GFR less than 45 or serum creatinine over 2.0 mg/dL)
  • Sensory or motor nerve damage in the feet
  • Active skin wounds on the bottom of the affected foot

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IR Centers

Falls Church, Virginia, United States, 22043

Actively Recruiting

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Research Team

S

Sindhuja Kommidi Clinical Research Coordinator, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis | DecenTrialz