Plantar Fasciitis, ChronicPhase 1NCT07395128
Lateral Plantar Artery Embolization For Plantar Fasciitis
A Phase 1 study testing Lipiodol in people with Plantar Fasciitis, Chronic and Plantar Fasciitis, run by Joint & Vascular Institute at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if lateral plantar artery embolization using Lipiodol can safely and effectively treat chronic heel pain due to plantar fasciitis in adults aged 25 to 80. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Plantar Fasciitis, Chronic, Plantar Fasciitis
- What is being tested?
- Lipiodol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2025to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 25 years
- Subject provides written informed consent
- Patient with Plantar Fasciitis refractory to 3 months of conservative management
- Self reported pain of at least 4/10 on visual analog scale (VAS)
- Non-surgical candidate/looking to avoid surgery
Who cannot join
- Heel pain caused by acute fracture, recent trauma, inflammatory conditions, muscle/ligament injury, and etiologies related to bone mineral density.
- Steroid injection in the last 90 days from the embolization procedure
- Known severe allergy to Lipiodol and/or iodinated contrast media
- Diagnosis of peripheral arterial disease affecting the lower extremities
- Pregnancy or breastfeeding
- Anticoagulation or irreversible coagulopathy
- GFR <45 or Serum creatinine > 2.0 mg/dl
- Type 1 Diabetes Mellitus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Joint and Vascular Institute
Libertyville, Illinois, 60048
Layth Alkhani, 847-584-3959, lalkhani@jointvascular.com
About this study
Official title: Lateral Plantar Artery Embolization to Treat Pain Chronic Heel Pain Due To Plantar Fasciitis A Pilot Study to Assess Feasibility
The goal of this clinical trial is to learn if lateral plantar artery embolization using Lipiodol can safely and effectively treat chronic heel pain due to plantar fasciitis in adults aged 25 to 80. The main questions it aims to answer are:
Does this procedure successfully reduce chronic heel pain as measured by the Visual Analog Scale (VAS) over 12 months?
Read more
How safe is the procedure, specifically regarding the frequency of serious medical problems or adverse events related to the device?
Participants will:
Undergo a minimally invasive procedure where a doctor uses a small tube (catheter) to inject a temporary blocking agent (LipioJoint) into specific blood vessels in the foot.
Receive a phone call one day after the procedure to check for early side effects.
Participate in four follow-up telehealth visits over the course of one year (at 1, 3, 6, and 12 months).
Complete pain intensity surveys (VAS) and report any changes in their use of other therapies or medications during these visits.
- Conditions
- Plantar Fasciitis, Chronic, Plantar Fasciitis
- Being tested
- Lipiodol
- Keywords
- plantar fasciitis
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipiodolDevice
Participants will receive a transcatheter arterial embolization of the lateral plantar artery branches. The intervention involves the selective catheterization of the calcaneal branches under fluoroscopic guidance using a microcatheter. A mixture of Lipiodol (a transient liquid embolic agent) and iodinated contrast media is injected until an endpoint of "near stasis" is reached. A maximum of 5 mL of Lipiodol will be used per procedure. This intervention specifically targets the hypervascularity (neovascularization) associated with chronic plantar fasciitis to alleviate pain and reduce inflammation.
| Study group | Role | What they receive |
|---|---|---|
| Lateral Plantar Artery Embolization | Experimental | Not described Receives: Device: Lipiodol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Change
Pain - measured via VAS at baseline, 1-month, 3-month, 6-month, and 12-month follow-up
Measured: Baseline to 12 months
Safety (rate of adverse events)
Safety - Percentage of subjects without serious adverse events related to the medical device
Measured: Baseline to 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start20 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar Fasciitis, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joint & Vascular Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395128
- Sponsor's protocol ID
- 1402856
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Plantar Artery Embolization to Treat Pain Chronic Heel Pain Due To Plantar Fasciitis A Pilot Study to Assess Feasibility
- ClinicalTrials.gov ID
- NCT07395128
- Acronym / sponsor ID
- 1402856
- Conditions
- Plantar Fasciitis, Chronic, Plantar Fasciitis
- Keywords
- plantar fasciitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Joint & Vascular InstituteIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if lateral plantar artery embolization using Lipiodol can safely and effectively treat chronic heel pain due to plantar fasciitis in adults aged 25 to 80. The main questions it aims to answer are:
Does this procedure successfully reduce chronic heel pain as measured by the Visual Analog Scale (VAS) over 12 months?
How safe is the procedure, specifically regarding the frequency of serious medical problems or adverse events related to the device?
Participants will:
Undergo a minimally invasive procedure where a doctor uses a small tube (catheter) to inject a temporary blocking agent (LipioJoint) into specific blood vessels in the foot.
Receive a phone call one day after the procedure to check for early side effects.
Participate in four follow-up telehealth visits over the course of one year (at 1, 3, 6, and 12 months).
Complete pain intensity surveys (VAS) and report any changes in their use of other therapies or medications during these visits.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lateral Plantar Artery Embolization | Experimental | Device: Lipiodol |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 25 years
- Subject provides written informed consent
- Patient with Plantar Fasciitis refractory to 3 months of conservative management
- Self reported pain of at least 4/10 on visual analog scale (VAS)
- Non-surgical candidate/looking to avoid surgery
Key exclusion criteria (8 listed)
- Heel pain caused by acute fracture, recent trauma, inflammatory conditions, muscle/ligament injury, and etiologies related to bone mineral density.
- Steroid injection in the last 90 days from the embolization procedure
- Known severe allergy to Lipiodol and/or iodinated contrast media
- Diagnosis of peripheral arterial disease affecting the lower extremities
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipiodolParticipants will receive a transcatheter arterial embolization of the lateral plantar artery branches. The intervention involves the selective catheterization of the calcaneal branches under fluoroscopic guidance using a microcatheter. A mixture of Lipiodol (a transient liquid embolic agent) and iodinated contrast media is injected until an endpoint of "near stasis" is reached. A maximum of 5 mL of Lipiodol will be used per procedure. This intervention specifically targets the hypervascularity (neovascularization) associated with chronic plantar fasciitis to alleviate pain and reduce inflammation. | Device | Lateral Plantar Artery Embolization |
Primary outcome
Pain Change
Time frame: Baseline to 12 months
Pain - measured via VAS at baseline, 1-month, 3-month, 6-month, and 12-month follow-up
Safety (rate of adverse events)
Time frame: Baseline to 12 month follow-up
Safety - Percentage of subjects without serious adverse events related to the medical device
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lipiodol in people with Plantar Fasciitis, Chronic and Plantar Fasciitis, run by Joint & Vascular Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Layth Alkhani (847-584-3959, lalkhani@jointvascular.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Change (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.