Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- IR Centers
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Reduction in Pain (VAS Score)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Reduction in Pain (VAS Score)
Time Frame: Baseline to 6 months
Change in pain level as measured by the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable).
Secondary Outcomes
- Improvement in Foot Function (FAAM Score)(Baseline to 6 months)