Actively Recruiting

Phase 1
Age: 25Years - 80Years
All Genders
NCT07477860

Achilles Tendinopathy Embolization

Led by Joint & Vascular Institute · Updated on 2026-04-23

10

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 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

Official Title

Achilles Tendinopathy Embolization

Who Can Participate

Age: 25Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 25 years or older
  • Ability to provide written informed consent
  • Diagnosed with Achilles tendinopathy not improved after 3 months of conservative treatment
  • Self-reported pain score of at least 4 out of 10 on the visual analog scale
  • Non-surgical candidate or prefers to avoid surgery
Not Eligible

You will not qualify if you...

  • Achilles tendon pain caused by acute fracture, recent trauma, inflammatory conditions, muscle or ligament injury, tendon rupture, or bone mineral density issues
  • Received steroid injection within 90 days before the procedure
  • Severe allergy to Lipiodol or iodinated contrast media
  • Peripheral arterial disease affecting the lower limbs
  • Pregnant or breastfeeding
  • On anticoagulation therapy or has irreversible coagulopathy
  • Kidney function impairment with GFR less than 45 or serum creatinine over 2.0 mg/dl
  • Diagnosed with Type 1 Diabetes Mellitus

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Joint and Vascular Institute

Libertyville, Illinois, United States, 60048

Actively Recruiting

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Research Team

L

Layth Alkhani

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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