IR Centers
Falls Church, Virginia, 22043, United States
Location status: Recruiting
Location contact
Sandeep Bagla, MD
PRINCIPAL_INVESTIGATOR
Sindhuja Kommidi Clinical Research Coordinator, MS
CONTACT
NCT Number: NCT06805942
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.
Interested in participating?
Request Info22 year–100 year
All sexes
Interventional
Not applicable
Falls Church, Virginia, 22043, United States
Location status: Recruiting
Sandeep Bagla, MD
PRINCIPAL_INVESTIGATOR
Sindhuja Kommidi Clinical Research Coordinator, MS
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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Lipiodol will be used as an embolic agent for arterial embolization targeting neovascularity in the plantar fascia to reduce inflammation and pain.
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).
Time frame: Baseline to 6 months
Change in function as assessed by the Foot and Ankle Ability Measure (FAAM), including activities of daily living and sports subscales.
Contact information is provided by the study sponsor or research team.
IR Centers
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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