Lateral Plantar Artery Embolization For Plantar Fasciitis
RecruitingPhase 1NCT07395128
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Lateral Plantar Artery Embolization to Treat Pain Chronic Heel Pain Due To Plantar Fasciitis A Pilot Study to Assess Feasibility
- Interventions
- Device: Lipiodol
- Sponsor
- Joint & Vascular Institute
- Start date
- 2025-12-20
- Primary completion
- 2027-03
- Sex
- All
- Age range
- from 25 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07395128