Lateral Plantar Artery Embolization For Plantar Fasciitis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age25-80
SponsorJoint & Vascular Institute
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Lipiodol
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov