Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis
ConditionPlantar Fasciitis of Both Feet
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-100
SponsorIR Centers
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Lipiodol (ethiodized oil) injection
DeviceLipiodol will be used as an embolic agent for arterial embolization targeting neovascularity in the plantar fascia to reduce inflammation and pain.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Single Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Reduction in Pain (VAS Score)
Change in pain level as measured by the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable).
Time frame
Baseline to 6 monthsSecondary outcomes
1
Improvement in Foot Function (FAAM Score)
Change in function as assessed by the Foot and Ankle Ability Measure (FAAM), including activities of daily living and sports subscales.
Time frame
Baseline to 6 months Source ClinicalTrials.gov