Lateral Plantar Artery Embolization For Plantar Fasciitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lipiodol.
- Who it may be relevant to
- Registry conditions: Plantar Fasciitis, Chronic, Plantar Fasciitis. Basic parameters: 25 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Lateral Plantar Artery Embolization to Treat Pain Chronic Heel Pain Due To Plantar Fasciitis A Pilot Study to Assess Feasibility
Overview
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.
Interventions
- Device 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
Primary outcome measures
- Pain Change [Time frame: Baseline to 12 months]
- Safety (rate of adverse events) [Time frame: Baseline to 12 month follow-up]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- Joint and Vascular Institute — Libertyville
Identifiers
NCT: NCT07395128 · 1402856