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A study to investigate the safety, tolerability and preliminary efficacy of NGI226 microparticles in patients with Achilles tendinopathy
EU CTIS ID: 2022-500863-10-00
What this study is testing
To assess the local and systemic safety and tolerability of a single peritendon injection of NGI226 MP in patients with mid-portion Achilles tendinopathy
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent prior to all study specific screening procedures must be obtained
- Adults 30 to 70 years of age (both inclusive)
- Presence of clinically (local Achilles tendon pain on tendon-loading activities, pain on palpation at the level 2-6 cm proximal to the calcaneal insertion) and
- Ultrasound (local tendon thickening with hypoechogenicities and irregular fibre orientation) or MRI (Magnetic Resonance Imaging) diagnosed mid-portion Achilles tendinopathy
- Symptoms present ≥8 weeks but <12 months
- Achilles tendinopathy must have been refractory to at least 6 weeks of conservative treatment (physiotherapy, NSAIDs (Non Steroidal Anti Inflammatory Drugs), Rest Ice Compression Elevation (RICE))
You likely can't join if
- Medical condition that would affect safety of peritendon injection (e.g., peripheral vascular disease, use of anticoagulant medication)
- History of recurrent, acute, symptomatic infections, including outbreaks of oral or genital herpes (> 2 symptomatic infections or >2 courses of anti-infective treatments required in the last 6 months; active systemic infection during last 2 weeks; known active infections (e.g. chronic or active Hepatis B or C, HIV) - simple cold excluded
- History or evidence of clinically significant cardiac or cardiovascular disease
- History of deep vein thrombosis, pulmonary embolism or evidence of primary or secondary hypercoagulable states
- History of surgical intervention for the treatment of tendinopathy, history of ankle surgery, ankle arthritis, traumatic, inflammation or deformity of ankle
- History of full-thickness tear or complete rupture of the Achilles tendon
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.