Recruiting

Embolization

Sponsor:

IR Centers

Code:

NCT06805942

Conditions

Plantar Fasciitis of Both Feet

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Lipiodol (ethiodized oil) injection

Study Details

Brief 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.

Conditions

Plantar Fasciitis of Both Feet

Study ID

NCT06805942

Start date

Feb 15, 2025

Status verified date

Jan, 2025

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Intervention Group

Participants in this arm will receive plantar fascia embolization (PFE) using Lipiodol (ethiodized oil) to treat pain caused by plantar fasciitis.

Interventions

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 measure

  • Reduction in Pain (VAS Score) [ Time Frame: Baseline to 6 months ]

Central Contacts and Locations

Central contacts

Sindhuja Kommidi Clinical Research Coordinator, MS

7327831259sindhu@ircenters.com

Locations

IR Centers

Recruiting

Falls Church, Virginia, United States, 22043

Contacts

Sindhuja Kommidi Clinical Research Coordinator, MS

732-783-1259sindhu@ircenters.com

Principal Investigator:

Sandeep Bagla, MD

More Information

Sponsor

IR Centers

Last update posted

Feb 3, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IR Centers on 2025-02-03.