Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
IR Centers
Falls Church, Virginia, United States, 22043
Actively Recruiting
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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