Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis

Обзор

This study evaluates the feasibility and safety of using Lipiodol (ethiodized oil) as an investigational embolic agent for treating pain caused by plantar fasciitis. Participants will undergo a minimally invasive procedure called plantar fascia embolization (PFE) to reduce inflammation and pain in the affected area. The study aims to assess changes in pain levels, foot function, and any potential side effects over a six-month follow-up period.

Подробное описание

This study investigates the use of Lipiodol (ethiodized oil) for plantar fascia embolization (PFE) to treat pain from plantar fasciitis. It focuses on evaluating safety, feasibility, and outcomes related to pain reduction and improved foot function.

Вмешательства

• Устройство Lipiodol (ethiodized oil) injection
  Lipiodol will be used as an embolic agent for arterial embolization targeting neovascularity in the plantar fascia to reduce inflammation and pain.

Первичные конечные точки

• Reduction in Pain (VAS Score) [Срок оценки: Baseline to 6 months]

Вторичные конечные точки (1)

• Improvement in Foot Function (FAAM Score) [Срок оценки: Baseline to 6 months]

Критерии участия

Inclusion Criteria:Participants aged 22 years or older. Diagnosed with plantar fasciitis by an orthopedic or podiatry surgeon.

Ultrasound evaluation showing:

Increased plantar fascia thickness > 4 mm. Hyperemia in the plantar fascia near its proximal insertion or perifascial soft tissue.

Self-reported pain of at least 5/10 on the Visual Analog Scale (VAS). Negative X-ray for acute fractures. Refractory to at least 6 weeks of conservative therapies. Able to provide written informed consent. -

Exclusion Criteria:Heel pain caused by stress fractures, nerve entrapment, or inflammatory conditions such as arthritis, gout, or bursitis.

Corticosteroid injection in the plantar fascia within 90 days prior to embolization.

Prior surgical repair or plantar fascia rupture. Severe allergy to Lipiodol or iodinated contrast media. Diagnosis of peripheral arterial disease affecting the lower extremities. Active workers' compensation claim for plantar fasciitis. Pregnancy or breastfeeding. Type 1 Diabetes Mellitus or significant renal dysfunction (GFR < 45 or serum creatinine > 2.0 mg/dL).

Sensory or motor neuropathy of the feet. Active skin wounds on the plantar surface of the affected foot.

\-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• IR Centers — Falls Church

Публикации

• Gandhi R, Banker M. Early outcomes of transcatheter arterial embolization using imipenem/cilastatin for plantar fasciitis refractory to conservative therapy. Br J Radiol. 2024 Feb 28;97(1155):544-548. doi: 10.1093/bjr/tqae012. PMID 38281074
• Sasaki T, Shibuya M, Miyazaki K, Nakata M, Kawabe A, Nakasone T, Sakai N, Okuno Y. Clinical results of ultrasound-guided intra-arterial embolization targeting abnormal neovessels for plantar fasciitis: 66 cases with up to 4 years of follow-up. Foot Ankle Surg. 2025 Feb;31(2):105-110. doi: 10.1016/j.fas.2024.07.009. Epub 2024 Jul 27. PMID 39089905
• Sapoval M, Querub C, Pereira H, Pellerin O, Boeken T, Di Gaeta A, Ahmar MA, Lefevre-Colau MM, Nguyen C, Daste C, Lacroix M, Laredo JD, Sabatier B, Martelli N, Chatellier G, Dean C, Rannou F. Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial. Diagn Interv Imaging. 2024 Apr;105(4):144-150. doi: 10.1016/j.diii.2023.12.003. Epub 2023 Dec 14. PMID 38102013

Идентификаторы

NCT: NCT06805942 · 12382

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗