ClinicalTrials.gg
RecruitingNCT06805942Updated Feb 3, 2025

Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis

An interventional study of Lipiodol (ethiodized oil) injection in Plantar Fasciitis of Both Feet, sponsored by IR Centers. Recruiting at 1 site in United States. Open to participants aged 22 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by IR Centers · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
22 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 45 studies in Fasciitis, Plantar with a site in United States — 6 open to participants now, 6 under way, none of them phase 3. Fasciitis, Plantar · United States.

Planned enrollment
38th of 44
10 · median 55
Started
2025
with 2 others
No phase
26 of 45
3 open now
Registered
42nd of 45
by date

Among the 45 studies in Fasciitis, Plantar with a site in United States, this one is the 38th largest by planned enrollment of the 44 interventional ones that give a count, is one of 3 that started in 2025, is one of 26 with no phase, and was the 42nd registered.

Fasciitis, Plantar

223 studies on the registry are indexed under Fasciitis, Plantar; 58 are open to participants now.

This study's planned enrollment of 10 is below the median of 56 across 194 interventional studies indexed under Fasciitis, Plantar.

Browse Fasciitis, Plantar studies →

Open to participants now

6 of the 45 studies in Fasciitis, Plantar with a site in United States are open now, in 1 country. Each count lists the studies.

All 6 open studies →

Where they have run

Who these studies take

Of the 29 Fasciitis, Plantar studies recruiting now, 5 (17%) set no upper age limit and 21 (72%) stop at 75 or younger; 0 take children under 18; 4 take healthy volunteers.

This study: 22 Years to 100 Years · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 45 studies in Fasciitis, Plantar with a site in United States, or all of them as a file.
02

Study 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.

Read the detailed description

This study investigates the use of Lipiodol (ethiodized oil) for plantar fascia embolization (PFE) to treat pain from plantar fasciitis. It focuses on evaluating safety, feasibility, and outcomes related to pain reduction and improved foot function.

03

Conditions studied

  • Plantar Fasciitis of Both Feet

Browse trials for

04

Who can participate

Ages eligible
22 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:Participants aged 22 years or older. Diagnosed with plantar fasciitis by an orthopedic or podiatry surgeon.

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. to at least 6 weeks of conservative therapies. Able to provide written . -

Exclusion Criteria:Heel pain caused by stress fractures, nerve entrapment, or inflammatory conditions such as arthritis, gout, or bursitis.

injection in the plantar fascia within 90 days prior to embolization.

Prior surgical repair or plantar fascia rupture. Severe allergy to Lipiodol or iodinated contrast media. Diagnosis of peripheral arterial disease affecting the lower extremities. Active workers' compensation claim for plantar fasciitis. Pregnancy or breastfeeding. Type 1 Diabetes Mellitus or significant renal dysfunction ( \< 45 or serum creatinine > 2.0 mg/dL).

Sensory or motor neuropathy of the feet. Active skin wounds on the plantar surface of the affected foot.

-

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • 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.

    Device: Lipiodol (ethiodized oil) injection

Interventions

  • DeviceLipiodol (ethiodized oil) injection

    Lipiodol will be used as an embolic agent for arterial embolization targeting neovascularity in the plantar fascia to reduce inflammation and pain.

06

What researchers measure

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 months

Secondary 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

07

Study locations

1 of 1 sites recruiting
  • IR Centers
    Falls Church, Virginia 22043, United States
    Recruiting
    • Sindhuja Kommidi Clinical Research Coordinator, MS · Contactsindhu@ircenters.com · 732-783-1259
    • Sandeep Bagla, MD · Principal investigator
08

References and documents

Publications

  • Gandhi R, Banker M. Early outcomes of transcatheter arterial embolization using imipenem/cilastatin for plantar fasciitis refractory to conservative therapy. Br J Radiol. 2024 Feb 28;97(1155):544-548. doi: 10.1093/bjr/tqae012. PubMed 38281074 ↗
  • Sasaki T, Shibuya M, Miyazaki K, Nakata M, Kawabe A, Nakasone T, Sakai N, Okuno Y. Clinical results of ultrasound-guided intra-arterial embolization targeting abnormal neovessels for plantar fasciitis: 66 cases with up to 4 years of follow-up. Foot Ankle Surg. 2025 Feb;31(2):105-110. doi: 10.1016/j.fas.2024.07.009. Epub 2024 Jul 27. PubMed 39089905 ↗
  • Sapoval M, Querub C, Pereira H, Pellerin O, Boeken T, Di Gaeta A, Ahmar MA, Lefevre-Colau MM, Nguyen C, Daste C, Lacroix M, Laredo JD, Sabatier B, Martelli N, Chatellier G, Dean C, Rannou F. Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial. Diagn Interv Imaging. 2024 Apr;105(4):144-150. doi: 10.1016/j.diii.2023.12.003. Epub 2023 Dec 14. PubMed 38102013 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2025; primary completion for Sep 2025, 7 months later.

Of 104 non-industry interventional studies with no phase under Fasciitis, Plantar, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's planned 7 months is below that.

Counting every sponsor, half of 109 studies reached it within 11 months; a quarter within 6 and three quarters within 22.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 28, 2025
First posted
Feb 3, 2025
StartEst.
Feb 15, 2025
Primary completionEst.
Sep 30, 2025
CompletionEst.
Sep 30, 2025
Last update
Feb 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06805942
Lead sponsor
IR Centers
Responsible party
Sponsor
First posted
Feb 3, 2025
Start date
Feb 15, 2025 (estimated)
Primary completion
Sep 30, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Feb 3, 2025

Study contacts

Sindhuja Kommidi Clinical Research Coordinator, MS
Contact
sindhu@ircenters.com
7327831259
Sandeep Bagla, MD
principal investigator · IR Centers

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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