Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis (NCT06805942) | Clinical Trial Compass
RecruitingNot Applicable
Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis
United States10 participantsStarted 2025-02-15
Plain-language 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.
Who can participate
Age range
22 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
\-
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in Pain (VAS Score)
Timeframe: Baseline to 6 months
Trial details
NCT IDNCT06805942
SponsorIR Centers
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2025-09-30
Contact for this trial
Sindhuja Kommidi Clinical Research Coordinator, MS