Lipiodol Injection for Plantar Fasciitis

Recruiting in Falls Church (>99 mi)

Overseen By Sindhuja Kommidi Clinical Research Coordinator, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: IR Centers

Must not be taking: Corticosteroids

Disqualifiers: Arthritis, Gout, Bursitis, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

10 Participants Needed

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. ^{1 2 3 4 5}

Research Team

Sandeep Bagla, MD

Principal Investigator

IR Centers

Eligibility 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

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.

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)

Treatment Details

Interventions

• Lipiodol (ethiodized oil)

Trial Overview 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.

Participant Groups

Group I: Single Intervention Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

IR Centers

Lead Sponsor

Trials

1

Recruited

10+

Findings from Research

A novel treatment using autologous blood conditioned with gold particles showed promising safety and efficacy in a single case of recalcitrant plantar fasciosis in an Olympic equestrian athlete.

After four injections of the GOLDIC® therapy, the patient experienced significant improvements in pain and function, allowing a return to competitive sports within 8 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gold-Induced Cytokine (GOLDIC®) Injection Therapy in Patient with Plantar Fasciosis: A Case Report. Melo, SNS., Ezekwesili, A., Yurdi, NA., et al.[2021]

In a study of 64 patients with plantar fasciosis, both ultrasound-guided intratissue percutaneous electrolysis (EPI) and corticosteroid infiltration (CI) showed significant improvements in pain and function after 12 months.

Corticosteroid infiltration required fewer visits and provided slightly better outcomes on pain and function scales compared to EPI, suggesting it may be a more convenient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intratissue Percutaneous Electrolysis vs Corticosteroid Infiltration for the Treatment of Plantar Fasciosis. Iborra-Marcos, Á., Ramos-Álvarez, JJ., Rodriguez-Fabián, G., et al.[2019]

In a study of 24 patients with chronic plantar fasciopathy, platelet-rich plasma (PRP) injections led to significant improvements in pain and disability scores after 32 weeks, indicating its efficacy as a treatment option.

The treatment was found to be safe, with no serious adverse events reported, suggesting that PRP could be a viable alternative for patients who do not respond to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma for the treatment of chronic plantar fasciopathy in adults: a case series. Wilson, JJ., Lee, KS., Miller, AT., et al.[2015]

Platelet-rich plasma (PRP) injections show superior pain control compared to corticosteroid injections for plantar fasciitis, particularly at 3 months and lasting up to 1 year, based on a systematic review of 15 studies.

Despite the promising results for PRP, the overall quality of the studies was low, with high risk of bias, which suggests that these findings should be interpreted cautiously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma Versus Corticosteroids for the Treatment of Plantar Fasciitis: A Systematic Review and Meta-analysis. Hohmann, E., Tetsworth, K., Glatt, V.[2021]

Corticosteroids were more effective than whole blood in reducing pain for plantar fasciopathy patients at 1.5 and 3 months, but this effect diminished by 6 months, indicating a short-term benefit.

Platelet-rich plasma (PRP) showed superior long-term pain relief at 6 months compared to corticosteroids, particularly with specific preparation techniques, suggesting PRP may be a better option for sustained pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous Blood-Derived Products Compared With Corticosteroids for Treatment of Plantar Fasciopathy: A Systematic Review and Meta-Analysis. Chen, YJ., Wu, YC., Tu, YK., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Gold-Induced Cytokine (GOLDIC®) Injection Therapy in Patient with Plantar Fasciosis: A Case Report. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Intratissue Percutaneous Electrolysis vs Corticosteroid Infiltration for the Treatment of Plantar Fasciosis. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma for the treatment of chronic plantar fasciopathy in adults: a case series. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma Versus Corticosteroids for the Treatment of Plantar Fasciitis: A Systematic Review and Meta-analysis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Autologous Blood-Derived Products Compared With Corticosteroids for Treatment of Plantar Fasciopathy: A Systematic Review and Meta-Analysis. [2020]