Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 100
Healthy Volunteers: f
View:

• 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. -

Locations
United States
Virginia
IR Centers
RECRUITING
Falls Church
Contact Information
Primary
Sindhuja Kommidi Clinical Research Coordinator, MS
sindhu@ircenters.com
7327831259
Time Frame
Start Date: 2025-02-15
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 10
Treatments
Experimental: Single Intervention Group
Participants in this arm will receive plantar fascia embolization (PFE) using Lipiodol (ethiodized oil) to treat pain caused by plantar fasciitis.
Related Therapeutic Areas
Sponsors
Leads: IR Centers

This content was sourced from clinicaltrials.gov