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Achilles Tendinopathy Embolization

RecruitingPhase 1Ages 25 Years - 80 YearsAllJoint & Vascular Institute
NCT07477860 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn determine the feasibility of arterial embolization using Lipiodol emulsion to safely and effectively treat chronic Achilles tendon pain due to Achilles tendinopathy in adults aged 25 to 80. The main questions it aims to answer are: 1. Does this procedure successfully reduce chronic Achilles tendon pain as measured by the Visual Analog Scale (VAS) over 12 months? 2. 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 supplying the Achilles tendon. * Receive a phone call one day after the procedure to check for early side effects. * Participate in four follow-up visits over the course

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 25 years * Subject provides written informed consent * Patient with Achilles tendinopathy 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 Exclusion Criteria: * Achilles tendon pain caused by acute fracture, recent trauma, inflammatory conditions, muscle/ligament injury, tendon rupture, 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
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What it tests

  • LipioJoint
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Where

1 site
Joint and Vascular Institute
Libertyville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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