Recruiting
Phase 1

Lipiodol

Sponsor:

Joint & Vascular Institute

Code:

NCT07395128

Conditions

Plantar Fasciitis, Chronic

Plantar Fasciitis

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Lipiodol

Study Details

Brief summary:

The goal of this clinical trial is to learn if lateral plantar artery embolization using Lipiodol can safely and effectively treat chronic heel pain due to plantar fasciitis in adults aged 25 to 80. The main questions it aims to answer are:

Does this procedure successfully reduce chronic heel pain as measured by the Visual Analog Scale (VAS) over 12 months?

How safe is the procedure, specifically regarding the frequency of serious medical problems or adverse events related to the device?

Participants will:

Undergo a minimally invasive procedure where a doctor uses a small tube (catheter) to inject a temporary blocking agent (LipioJoint) into specific blood vessels in the foot.

Receive a phone call one day after the procedure to check for early side effects.

Participate in four follow-up telehealth visits over the course of one year (at 1, 3, 6, and 12 months).

Complete pain intensity surveys (VAS) and report any changes in their use of other therapies or medications during these visits.

Conditions

Plantar Fasciitis, Chronic

Plantar Fasciitis

Study ID

NCT07395128

Start date

Dec 20, 2025

Status verified date

Feb, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Lateral Plantar Artery Embolization

Interventions

Lipiodol

Participants will receive a transcatheter arterial embolization of the lateral plantar artery branches. The intervention involves the selective catheterization of the calcaneal branches under fluoroscopic guidance using a microcatheter. A mixture of Lipiodol (a transient liquid embolic agent) and iodinated contrast media is injected until an endpoint of "near stasis" is reached. A maximum of 5 mL of Lipiodol will be used per procedure. This intervention specifically targets the hypervascularity (neovascularization) associated with chronic plantar fasciitis to alleviate pain and reduce inflammation.

Primary outcome measure

  • Pain Change [ Time Frame: Baseline to 12 months ]
  • Safety (rate of adverse events) [ Time Frame: Baseline to 12 month follow-up ]

Central Contacts and Locations

Central contacts

Layth Alkhani

847-584-3959lalkhani@jointvascular.com

Locations

Joint and Vascular Institute

Recruiting

Libertyville, Illinois, United States, 60048

Contacts

Layth Alkhani

847-584-3959lalkhani@jointvascular.com

More Information

Sponsor

Joint & Vascular Institute

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

  • plantar fasciitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Joint & Vascular Institute on 2026-02-09.