Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis
Purpose
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.
Condition
- Plantar Fasciitis of Both Feet
Eligibility
- Eligible Ages
- Between 22 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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. -
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- This study uses a single-group assignment model where all enrolled participants will receive the same intervention, plantar fascia embolization (PFE) with Lipiodol, to evaluate its safety, feasibility, and effectiveness for treating plantar fasciitis
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Single Intervention Group |
Participants in this arm will receive plantar fascia embolization (PFE) using Lipiodol (ethiodized oil) to treat pain caused by plantar fasciitis. |
|
Recruiting Locations
Falls Church 4758390, Virginia 6254928 22043
More Details
- NCT ID
- NCT06805942
- Status
- Recruiting
- Sponsor
- IR Centers
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.