NCT06805942 · IR Centers
Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis
What this study is about
This study evaluates the feasibility and safety of using Lipiodol (ethiodized oil) as an experimental 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.
View original scientific description
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.
Interventions
DEVICE
Lipiodol (ethiodized oil) injection
Lipiodol will be used as an embolic agent for arterial embolization targeting neovascularity in the plantar fascia to reduce inflammation and pain.
Primary outcome measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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. \-
Where
- Falls Church, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 3, 2025 · Source of record for eligibility and locations