Embolization treatment for heel pain from plantar fasciitis
Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis
This study is testing a new treatment using a special substance to see if it can help people with heel pain from plantar fasciitis feel better and improve their foot function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 22 Years to 100 Years |
| Sex | All |
| Sponsor | IR Centers Academic / other |
| Locations | 1 site (Falls Church, Virginia) |
| Trial ID | NCT06805942 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of using Lipiodol, an investigational embolic agent, for treating heel pain caused by plantar fasciitis. Participants will undergo a minimally invasive procedure known as plantar fascia embolization (PFE) aimed at reducing inflammation and pain in the affected area. The study will assess changes in pain levels, foot function, and any potential side effects over a six-month follow-up period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 years or older with a diagnosis of plantar fasciitis who have not responded to at least six weeks of conservative therapies.
Not a fit: Patients with heel pain due to stress fractures, nerve entrapment, inflammatory conditions, or those who have had recent corticosteroid injections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce heel pain and improve foot function for patients suffering from plantar fasciitis.
How similar studies have performed: While the use of embolization for plantar fasciitis is a novel approach, similar studies in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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. \-
Where this trial is running
Falls Church, Virginia
- IR Centers — Falls Church, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Sandeep Bagla, MD — IR Centers
- Study coordinator: Sindhuja Kommidi Clinical Research Coordinator, MS
- Email: sindhu@ircenters.com
- Phone: 7327831259
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.