Lipiodol Injection for Plantar Fasciitis

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat pain from plantar fasciitis using Lipiodol (ethiodized oil) in a minimally invasive procedure. The goal is to determine if this treatment can safely reduce pain and improve foot function. Researchers will monitor participants for changes in pain and side effects over six months. Individuals diagnosed with plantar fasciitis, who have experienced symptoms despite six weeks of treatment, and who feel significant daily pain may be suitable for this trial. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could lead to new treatment options for plantar fasciitis.

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.

What prior data suggests that this method is safe for treating plantar fasciitis?

Research has shown that Lipiodol (ethiodized oil) has been used safely in other studies. Participants in these studies found it well-tolerated for similar procedures. While some side effects can occur, they are usually mild, such as minor discomfort or swelling in the treated area. Lipiodol is already approved by the FDA for other uses, indicating that its safety is well understood. It is important to consult a healthcare professional about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Lipiodol is unique because it offers a new way to treat plantar fasciitis through plantar fascia embolization (PFE). Most treatments for this condition, like physical therapy, orthotics, or corticosteroid injections, focus on reducing inflammation or supporting the foot structure. However, Lipiodol, an ethiodized oil, targets the blood vessels in the foot, potentially reducing pain by limiting blood supply to the inflamed tissue. Researchers are excited about this treatment because it represents a novel mechanism of action that might offer relief for patients who haven't responded to conventional therapies.

What evidence suggests that Lipiodol might be an effective treatment for plantar fasciitis?

Research has shown that Lipiodol, a type of oil, might help relieve pain from plantar fasciitis. Earlier studies used this oil to block blood flow to certain areas, reducing swelling and pain. In this trial, participants will undergo plantar fascia embolization (PFE) using Lipiodol. Early results suggest that this procedure can safely and effectively reduce pain and improve foot function. Although more research is needed, the initial findings are promising for those seeking relief from this painful condition. ^{1 2 4 6 7}

Who Is on the Research Team?

Sandeep Bagla, MD

Principal Investigator

IR Centers

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06805942

NCT06805942 | Embolization for the Treatment of Heel ... This study evaluates the feasibility and safety of using Lipiodol (ethiodized oil) as an investigational embolic agent for treating pain caused by plantar ...

2. jvir.org jvir.org/article/S1051-0443(24)01181-3/fulltext

A Pilot Study Evaluating Safety and Efficacy Using Lipiodol ... This study aims to assess the safety, efficacy, and technical feasibility of embolization using Guerbet Lipiodol (ethiodized oil) for treating pain secondary ...

3. trialstoday.org trialstoday.org/trial/NCT06805942

Embolization for the Treatment of Heel Pain Secondary ... This study evaluates the feasibility and safety of using Lipiodol (ethiodized oil) as an investigational embolic agent for treating pain caused ...

4. withpower.com withpower.com/trial/lipiodol-injection-for-plantar-fasciitis-f7df9

Lipiodol Injection for Plantar Fasciitis This study evaluates the feasibility and safety of using Lipiodol (ethiodized oil) as an investigational embolic agent for treating pain caused by plantar ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/location/united-states/VA/Falls%20Chruch

Falls Chruch, Virginia Clinical Research Trials This study investigates the use of Lipiodol (ethiodized oil) for plantar fascia embolization (PFE) to treat pain from plantar fasciitis. It focuses on ...

6. trialx.com trialx.com/clinical-trials/listings/320121/embolization-for-the-treatment-of-heel-pain-secondary-to-plantar-fasciitis/

Embolization for the Treatment of Heel Pain Secondary to ... The study aims to assess changes in pain levels, foot function, and any potential side effects over a six-month follow-up period. Description.

7. trial.medpath.com trial.medpath.com/clinical-trial/760fb6fd7027073a/embolization-heel-pain-plantar-fasciitis

Embolization for the Treatment of Heel Pain Secondary to Plantar ... This study evaluates the feasibility and safety of using Lipiodol (ethiodized oil) as an investigational embolic agent for treating pain caused by plantar ...