Achilles Tendinopathy Embolization
ConditionAchilles Tendinopathy (AT)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age25-80
SponsorJoint & Vascular Institute
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- LipioJoint
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov