Early outcomes of transcatheter arterial embolization using imipenem/cilastatin for plantar fasciitis refractory to conservative therapy.
Rozil Gandhi, Mohal Banker
https://pubmed.ncbi.nlm.nih.gov/38281074Actively Recruiting
Phase Not Applicable
Age: 22Years - 100Years
All Genders
ID06805942
Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis
Led by IR Centers · Updated on 2025-02-03
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of using Lipiodol (ethiodized oil) as an investigational embolic agent to treat pain caused by plantar fasciitis. This study focuses on a minimally invasive procedure called plantar fascia embolization (PFE), aiming to reduce inflammation and pain in the heel area. The study will assess changes in pain levels and foot function over a six-month period following treatment. Participants will receive plantar fascia embolization using Lipiodol, which targets the blood vessels in the plantar fascia to reduce inflammation and pain. This study involves a single intervention group receiving this treatment. The procedure is designed to be minimally invasive and is administered once during the study period. During the study, participants will be monitored for changes in pain using the Visual Analog Scale (VAS) and improvements in foot function using the Foot and Ankle Ability Measure (FAAM). Researchers will also watch for any side effects or safety concerns related to the treatment. The follow-up period lasts six months, allowing for thorough assessment of outcomes and participant well-being throughout the study.
CONDITIONS
Brief Title
Embolization for the Treatment of Heel Pain Secondary to Plantar Fasciitis
Who Can Participate
Age: 22Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- Participants aged 22 years or older
- Diagnosed with plantar fasciitis by an orthopedic or podiatry surgeon
- Ultrasound showing increased plantar fascia thickness greater than 4 mm
- Presence of increased blood flow (hyperemia) near the plantar fascia's proximal insertion or surrounding soft tissue
- Self-reported pain score of at least 5 out of 10 on the Visual Analog Scale (VAS)
- Negative X-ray for acute fractures
- Symptoms resistant to at least 6 weeks of conservative treatments
- Able to provide written informed consent
You will not qualify if you...
- Heel pain caused by stress fractures, nerve entrapment, or inflammatory conditions such as arthritis, gout, or bursitis
- Corticosteroid injection in the plantar fascia within 90 days prior to embolization
- Prior surgical repair or rupture of the plantar fascia
- Severe allergy to Lipiodol or iodinated contrast media
- Diagnosis of peripheral arterial disease affecting the lower limbs
- Active workers' compensation claim for plantar fasciitis
- Pregnancy or breastfeeding
- Type 1 Diabetes Mellitus or significant kidney dysfunction (GFR less than 45 or serum creatinine greater than 2.0 mg/dL)
- Sensory or motor neuropathy of the feet
- Active skin wounds on the plantar surface of the affected foot
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Single procedure with follow-up assessments up to 6 months
Participants receive plantar fascia embolization using Lipiodol (ethiodized oil) to treat heel pain caused by plantar fasciitis.
1 procedure visit and multiple follow-up visits over 6 months
Trial Site Locations
Total: 1 location
1
IR Centers
Falls Church, Virginia, United States, 22043
Actively Recruiting
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Research Team
S
Sindhuja Kommidi Clinical Research Coordinator, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Clinical results of ultrasound-guided intra-arterial embolization targeting abnormal neovessels for plantar fasciitis: 66 cases with up to 4 years of follow-up.
Takahide Sasaki, Masahiko Shibuya, Koichi Miyazaki...
https://pubmed.ncbi.nlm.nih.gov/39089905Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial.
Marc Sapoval, Charles Querub, Helena Pereira...
https://pubmed.ncbi.nlm.nih.gov/38102013