NCT06805942

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

February 15, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

January 28, 2025

Last Update Submit

January 31, 2025

Conditions

Plantar Fasciitis of Both Feet

Outcome Measures

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).

    Baseline to 6 months

Secondary Outcomes (1)

  • Improvement in Foot Function (FAAM Score)

    Baseline to 6 months

Study Arms (1)

Single Intervention Group

EXPERIMENTAL

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

Lipiodol (ethiodized oil) injectionDEVICE

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

Single Intervention Group

Eligibility Criteria

Age22 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. Refractory to at least 6 weeks of conservative therapies. Able to provide written informed consent. -

You may not qualify if:

  • Corticosteroid 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 (GFR \< 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IR Centers

Falls Church, Virginia, 22043, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 38281074RESULT

  • 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.

    PMID: 39089905RESULT

  • 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.

    PMID: 38102013RESULT

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Sandeep Bagla, MD

    IR Centers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sindhuja Kommidi Clinical Research Coordinator, MS

CONTACT

7327831259sindhu@ircenters.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study uses a single-group assignment model where all enrolled participants will receive the same intervention, plantar fascia embolization (PFE) with Lipiodol, to evaluate its safety, feasibility, and effectiveness for treating plantar fasciitis
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 3, 2025

Study Start

February 15, 2025

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)