Plantar Fasciitis of Both Feet
Conditions
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.
Detailed description
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.
Interventions
DEVICELipiodol (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.
Sponsors
IR Centers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study uses a single-group assignment model where all enrolled participants will receive the same intervention, plantar fascia embolization (PFE) with Lipiodol, to evaluate its safety, feasibility, and effectiveness for treating plantar fasciitis
Eligibility
Sex/Gender
ALL
Age
22 Years to 100 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Pain (VAS Score) | 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
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Foot Function (FAAM Score) | 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. |
Countries
United States
Contacts
Primary ContactSindhuja Kommidi Clinical Research Coordinator, MS
Outcome results
None listed