Lipiodol Injection for Plantar Fasciitis
Recruiting in Palo Alto (17 mi)
Overseen bySandeep Bagla, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: IR Centers
Must not be taking: Corticosteroids
Disqualifiers: Arthritis, Gout, Bursitis, Diabetes, others
No Placebo Group
Trial Summary
What is the purpose of 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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How does Lipiodol injection differ from other treatments for plantar fasciitis?
Lipiodol injection for plantar fasciitis is unique because it involves the use of ethiodized oil, which is not a standard treatment for this condition. Unlike corticosteroid injections or platelet-rich plasma (PRP) treatments, which are more commonly used, Lipiodol's mechanism and effects in plantar fasciitis are less established, making it a novel approach.
12345Eligibility Criteria
This trial is for individuals suffering from heel pain due to plantar fasciitis, who are looking for a non-surgical treatment option. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and have a confirmed diagnosis of the condition.Inclusion Criteria
I am 22 years old or older.
I have been diagnosed with plantar fasciitis by a specialist.
Negative X-ray for acute fractures
+4 more
Exclusion Criteria
Pregnancy or breastfeeding
Active workers' compensation claim for plantar fasciitis
My heel pain is due to a stress fracture, nerve issue, or inflammation like arthritis.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo plantar fascia embolization (PFE) using Lipiodol to treat pain caused by plantar fasciitis
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety, pain reduction, and foot function improvement over a six-month period
6 months
Multiple visits (in-person and/or virtual)
Participant Groups
The study is testing Lipiodol (ethiodized oil) injections as an embolic agent in a procedure called plantar fascia embolization (PFE). The goal is to see if this minimally invasive method can effectively reduce inflammation and alleviate pain from plantar fasciitis over six months.
1Treatment groups
Experimental Treatment
Group I: Single Intervention GroupExperimental Treatment1 Intervention
Participants in this arm will receive plantar fascia embolization (PFE) using Lipiodol (ethiodized oil) to treat pain caused by plantar fasciitis.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
IR CentersFalls Church, VA
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Who Is Running the Clinical Trial?
IR CentersLead Sponsor
References
Gold-Induced Cytokine (GOLDIC®) Injection Therapy in Patient with Plantar Fasciosis: A Case Report. [2021]A novel technique of cultivating autologous blood with gold particles; then separating the gold particles and cells from the serum and injecting the conditioned serum into affected plantar fascia. A first-time report of the safety and efficacy in treatment of recalcitrant plantar fasciosis in an Olympic equestrian. A single patient with clinical signs, symptoms and ultrasound evidence of plantar fasciosis was treated with four intra-ligamentous GOLDIC® injection therapy. The Olympic jumper was evaluated by Visual Analog Scale (VAS), Foot and Ankle Disability Index (FADI), and Global Rating of Change (GRoC) score(s) before injection and at 6-month follow-up. VAS, FADI, and GRoC scores showed substantial and marked improvement clinically. The subject was able to return to sport without limitations after 8 weeks. The initial result demonstrates that the treatment regimen is safe, and efficacious. The subject demonstrated reduction of pain, and improved function that allowed return to high level competition.
Intratissue Percutaneous Electrolysis vs Corticosteroid Infiltration for the Treatment of Plantar Fasciosis. [2019]Corticosteroid infiltration (CI) is commonly used for treatment of plantar fasciosis. In recent years, however, interest has grown in the use of intratissue percutaneous electrolysis (EPI) for the treatment of tendinopathies. The aim of our study was to compare the effectiveness of the above techniques in the treatment of plantar fasciosis.
Platelet-rich plasma for the treatment of chronic plantar fasciopathy in adults: a case series. [2015]Plantar fasciopathy (PF) is a common source of pain and disability that is often refractory to conservative management. There are no uniformly effective standard-of-care treatments for chronic recalcitrant PF. Corticosteroid injection is considered a viable treatment option when traditional therapies fail, but is limited by suboptimal long-term efficacy and potential adverse effects. Platelet-rich plasma (PRP) is an emerging injection-based treatment for various chronic degenerative soft-tissue diseases. It is postulated to promote native tissue regeneration; however, consistent scientific evidence remains lacking. A prospective case series, including 24 consecutive PF cases, was conducted to report patient-rated pain and disability following PRP injection. Foot and Ankle Ability Measure (FAAM) scores were the primary clinical outcome measure. Foot-Single Assessment Numeric Evaluation (Foot-SANE) scores, Short Form-12 Health Survey version 2 (SF-12v2) questionnaires, and PRP treatment satisfaction surveys were secondary outcome measures. Statistical analysis compared baseline and 32 weeks post-injection time points. Patients receiving PRP injection reported clinically and statistically significant improvement in all outcome measures during this interval. There were no serious adverse events associated with treatment. PRP is considered a safe therapeutic option with the ability to decrease heel pain in patients with chronic PF refractory to appropriate conservative management.
Platelet-Rich Plasma Versus Corticosteroids for the Treatment of Plantar Fasciitis: A Systematic Review and Meta-analysis. [2021]Plantar fasciitis is a common cause of heel pain. Corticosteroid injections are commonly used and proven to be effective, and lately platelet-rich plasma (PRP) has been used with mixed results.
Autologous Blood-Derived Products Compared With Corticosteroids for Treatment of Plantar Fasciopathy: A Systematic Review and Meta-Analysis. [2020]This review article evaluated the efficacy of autologous blood-derived products, including whole blood and platelet-rich plasma, in reducing pain and improving function compared with corticosteroids for plantar fasciopathy patients.