Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-15

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Plantar Fasciosis Treatment Using Coblation

NCT00189592

Plantar Fasciitis

COMPLETED PHASE4

Treatment of Plantar Fasciitis With Platelet Rich Plasma

NCT01127672

Plantar Fasciitis

WITHDRAWN NA

Percutaneous Needle Tenotomy Associated With Platelet-rich Plasma Injection Platelet-rich Plasma in the Treatment of Refractory Plantar Fasciitis: a Pilot Study of the Effect on Pain and Tolerance

NCT05622279

Plantar Fascitis

COMPLETED NA

Effectiveness of Infiltrations in the Treatment of Plantar Fasciopathy

NCT06671223

Plantar Fasciitis of Both Feet Plantar Fasciopathy

NOT_YET_RECRUITING NA

Perforating Fat Injections for Plantar Fasciosis

NCT02855983

Plantar Fascia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Plantar Fasciitis of Both Feet

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

This study uses a single-group assignment model where all enrolled participants will receive the same intervention, plantar fascia embolization (PFE) with Lipiodol, to evaluate its safety, feasibility, and effectiveness for treating plantar fasciitis

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single Intervention Group

Participants in this arm will receive plantar fascia embolization (PFE) using Lipiodol (ethiodized oil) to treat pain caused by plantar fasciitis.

Group Type EXPERIMENTAL

Lipiodol (ethiodized oil) injection

Intervention Type DEVICE

Lipiodol will be used as an embolic agent for arterial embolization targeting neovascularity in the plantar fascia to reduce inflammation and pain.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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.

\-

Minimum Eligible Age

22 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No