Lateral plantar artery embolization for chronic heel pain
Lateral Plantar Artery Embolization to Treat Pain Chronic Heel Pain Due To Plantar Fasciitis A Pilot Study to Assess Feasibility
This will test whether injecting a temporary blocking agent (Lipiodol) into the lateral plantar artery can reduce chronic heel pain in adults 25–80 who have not improved after at least three months of conservative care.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 25 Years to 80 Years |
| Sex | All |
| Sponsor | Joint & Vascular Institute Industry-sponsored |
| Locations | 1 site (Libertyville, Illinois) |
| Trial ID | NCT07395128 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional program uses a minimally invasive catheter to deliver Lipiodol into targeted lateral plantar arterial branches supplying the painful area of the heel. Patients undergo the embolization procedure at a single center and receive a phone check the day after, with telehealth follow-ups at 1, 3, 6, and 12 months. The main outcomes are change in pain on the Visual Analog Scale (VAS) over 12 months and the frequency of serious or device-related adverse events. Eligibility is limited to adults with chronic plantar fasciitis refractory to conservative treatment and excludes those with vascular disease, severe contrast allergy, significant renal dysfunction, pregnancy, or other specified conditions.
Who should consider this trial
Good fit: Adults aged 25–80 with chronic plantar fasciitis who have had at least three months of conservative therapy, report pain of 4/10 or greater on the VAS, and are trying to avoid surgery are ideal candidates.
Not a fit: People whose heel pain is due to fracture, recent trauma, inflammatory or bone-density related causes, those with peripheral arterial disease, severe contrast allergy, significant renal impairment, pregnancy, anticoagulation issues, or type 1 diabetes are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the procedure could reduce chronic heel pain and provide a less invasive option that helps some patients avoid surgery.
How similar studies have performed: Early case series and small pilot studies of arterial embolization for plantar fasciitis and other chronic tendinopathies have reported promising pain relief, but larger controlled trials are still needed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 25 years * Subject provides written informed consent * Patient with Plantar Fasciitis refractory to 3 months of conservative management * Self reported pain of at least 4/10 on visual analog scale (VAS) * Non-surgical candidate/looking to avoid surgery Exclusion Criteria: * Heel pain caused by acute fracture, recent trauma, inflammatory conditions, muscle/ligament injury, and etiologies related to bone mineral density. * Steroid injection in the last 90 days from the embolization procedure * Known severe allergy to Lipiodol and/or iodinated contrast media * Diagnosis of peripheral arterial disease affecting the lower extremities * Pregnancy or breastfeeding * Anticoagulation or irreversible coagulopathy * GFR \<45 or Serum creatinine \> 2.0 mg/dl * Type 1 Diabetes Mellitus
Where this trial is running
Libertyville, Illinois
- Joint and Vascular Institute — Libertyville, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Layth Alkhani
- Email: lalkhani@jointvascular.com
- Phone: 847-584-3959
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.