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NCT Number: NCT06805942

Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis

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.

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Key information

Age range

22 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

[email protected]

732-783-1259

About this study

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.

Who can participate

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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Treatment and study plan

Lipiodol (ethiodized oil) injection

Device

Lipiodol will be used as an embolic agent for arterial embolization targeting neovascularity in the plantar fascia to reduce inflammation and pain.

Primary outcomes

  1. 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

  1. Improvement in Foot Function (FAAM Score)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sindhuja Kommidi Clinical Research Coordinator, MS

CONTACT

[email protected]

7327831259

Sponsors and collaborators

Lead sponsor

IR Centers

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Feb 3, 2025

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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