Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis
Launched by IR CENTERS · Jan 31, 2025
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a new treatment option for people suffering from plantar fasciitis, a common condition that causes heel pain. Researchers are testing a procedure called plantar fascia embolization (PFE), which involves using a special oil called Lipiodol to reduce inflammation and pain in the plantar fascia, the thick band of tissue on the bottom of the foot. The goal is to see if this treatment can improve pain levels and foot function over a six-month period while ensuring it is safe for participants.
To join the study, participants need to be at least 22 years old and have been diagnosed with plantar fasciitis. They should have ongoing pain that has not improved after trying other treatments for at least six weeks. Participants will be carefully evaluated to confirm their condition and must be able to provide consent to take part in the trial. It's important to note that certain conditions, like stress fractures or severe allergies to the study medication, may prevent someone from participating. Those who do join can expect to undergo a minimally invasive procedure and will be monitored for any changes in their pain and foot function over time.
Gender
ALL
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.
- • -
About Ir Centers
IR Centers is a leading clinical trial sponsor dedicated to advancing innovative medical research in interventional radiology. With a focus on enhancing patient outcomes and safety, the organization collaborates with healthcare professionals and research institutions to design and implement rigorous clinical trials. IR Centers leverages cutting-edge technology and expert insights to evaluate new therapies and diagnostic tools, ensuring the highest standards of clinical excellence. Committed to transparency and ethical practices, IR Centers aims to contribute significantly to the body of knowledge in interventional radiology, ultimately improving treatment options for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Falls Church, Virginia, United States
Patients applied
Trial Officials
Sandeep Bagla, MD
Principal Investigator
IR Centers
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported