Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis: A Pilot Study Evaluating Safety and Efficacy Using Lipiodol® as a Novel Embolic Agent

Purpose: Plantar fasciitis (PF) is the leading cause of heel pain, affecting over 1 million individuals annually in the U.S., with approximately 10% lifetime incidence. Despite standard conservative treatments, many patients experience persistent or recurrent symptoms. This study aims to assess the safety, efficacy, and technical feasibility of embolization using Guerbet Lipiodol® (ethiodized oil) for treating pain secondary to PF. The hypothesis is that embolization of the neovascularity associated with PF will provide significant pain relief and functional improvement.

Materials and Methods: This open-label pilot study, approved under an FDA Investigational Device Exemption (IDE), will recruit 10 patients, all 22 years or older, with symptomatic PF refractory to conservative treatment for at least six weeks. Eligible subjects will be evaluated based on heel pain, vascular abnormalities seen on imaging, and strict inclusion and exclusion criteria. The treatment involves selectively embolizing hypervascular areas of the plantar fascia using Lipiodol, guided by fluoroscopy. Outcomes will be measured through pain reduction using the Visual Analog Scale (VAS) and functional improvement via the Foot and Ankle Ability Measure (FAAM) at baseline, 1, 3, and 6 months post-procedure. Technical success is defined by the reduction of fluoroscopic "blush," indicating effective embolization of inflammatory microvessels.

Results: The primary endpoints include assessing feasibility through pain reduction and functional improvement, and safety by monitoring adverse events related to the device. A decrease of ≥2 points on the VAS and an improvement of ≥8 points on the FAAM at 6 months will be considered significant. Secondary endpoints include the rate of technical success, defined as the deployment of Lipiodol in at least one artery with a corresponding reduction in vascular blush.

Conclusion: This pilot study aims to determine the safety and feasibility of plantar fascia embolization (PFE) using Lipiodol for PF. It builds upon the proven success of embolization for other musculoskeletal disorders and leverages the principal investigators' experience in pioneering embolization techniques.