A two part, randomized, participant and investigator-blinded, 2-arm, parallel-design, placebo-controlled study to evaluate the safety, tolerability and preliminary efficacy of NGI226 microparticles on tendon regeneration in patients with Achilles tendinopathy
This research study is investigating a new medication called NGI226. It's designed to treat Achilles tendinopathy, a common and often painful problem affecting the tendon at the back of your heel. The main goals of this study are to carefully check if the new treatment is safe for people to use and if it causes any side effects. We also want to understand how well people tolerate the treatment and if there are early signs that it helps the damaged tendon heal or regenerate. This is an early phase study, meaning it's one of the first times this treatment is being tested in a larger group of people.
At a glance
What is this study about?
This study is looking into a new approach to treat Achilles tendinopathy. This condition affects the Achilles tendon, the strong cord at the back of your ankle that connects your calf muscles to your heel bone. When this tendon gets overused or injured, it can become painful, stiff, and swollen, making it hard to walk or exercise.
The new treatment we're testing is called NGI226. It’s given as an injection directly into the affected area. The main purpose of this study is to find out if NGI226 is safe to use and if people can tolerate it without too much discomfort or side effects. We will also be watching closely for any early signs that it might help the tendon to repair itself.
To make sure we get reliable results, some people in the study will receive NGI226, while others will receive a placebo. A placebo looks exactly like the actual treatment but doesn't contain any active medicine. Neither you nor your study doctor will know whether you are receiving NGI226 or the placebo. This helps us objectively compare the effects of the new treatment. This is a Phase II study, which means it's an important step to see if the treatment works well enough to continue to larger studies in the future.
Key takeaways
- This study is testing a new treatment (NGI226) for Achilles tendinopathy.
- It aims to check the treatment's safety, how well people tolerate it, and if it helps with tendon repair.
- Participants will receive either the new treatment or a placebo (dummy drug).
- Regular health checks, blood tests, and special scans of your tendon will be part of the study.
- This is an early-stage (Phase II) study to gather important information about NGI226.
- You can withdraw from the study at any time without penalty.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women are welcome to participate. The study team will need to confirm you have Achilles tendinopathy, as this research is specifically for that condition.
There will be other specific health checks to make sure the study is a good fit for you and that it's safe for you to take part. For example, they'll check your general health and any other medications you might be taking. These checks are important to ensure your safety and the quality of the study results.
If you have other serious health conditions or are taking certain medicines, you might not be able to join. The study team will discuss all the requirements with you in detail.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with Achilles tendinopathy?
- Are you comfortable with regular clinic visits and health checks?
- Are you able to provide consent to take part in the study?
What does participation involve?
If you decide to take part in this study, you will have regular visits to the clinic. During these visits, the study team will carry out various checks including physical examinations of your ankle, blood tests, and possibly urine tests. Your heart activity will be checked with an electrocardiogram (ECG), and your blood pressure, pulse, and temperature will be measured.
You will receive either the investigational medication (NGI226) or a harmless placebo as an injection. You won't know which one you're getting. The study will involve monitoring any changes in your pain, swelling, redness, and how well you can move your ankle over several weeks.
The study will also use special ultrasound scans of your tendon to see if there are any changes in its stiffness after 12 weeks. The total duration of your participation, including all follow-up, will be explained by the study team, so you know exactly what to expect from start to finish.
Potential risks and benefits
Locations (3)
- —UnverifiedNetherlands
- —UnverifiedGermany
- —UnverifiedFrance
Common questions
What is Achilles tendinopathy?
It's a condition where the Achilles tendon, which connects your calf muscles to your heel, becomes painful, stiff, or swollen, often due to overuse.
What is NGI226?
NGI226 is a new medication being tested in this study to see if it can help heal or repair tendons affected by Achilles tendinopathy.
Will I know if I'm getting the real medicine or a dummy treatment?
No, neither you nor your study doctor will know whether you are receiving NGI226 or the placebo (dummy treatment). This is done to make the study results more reliable.
What does a 'Phase II' study mean?
It means this is an early-stage study, one of the first times the treatment is being tested in a larger group of people to evaluate its safety and if it shows early signs of working.
Can I leave the study if I change my mind?
Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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