Study on the Safety and Effects of NGI226 Microparticles for Patients with Achilles Tendinopathy

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What is this study about?

This clinical trial is focused on studying Achilles tendinopathy, a condition that causes pain and swelling in the tendon at the back of the ankle. The study will evaluate a new treatment called NGI226, which is a powder mixed into a liquid and injected near the affected tendon. The purpose of the study is to assess the safety and initial effectiveness of this treatment in helping the tendon heal.

Participants in the study will receive either the NGI226 treatment or a placebo, which looks like the treatment but does not contain the active substance. The study is designed to be “blinded,” meaning neither the participants nor the researchers will know who receives the actual treatment or the placebo. This helps ensure the results are unbiased. The study will monitor participants for any side effects and changes in their symptoms over time.

The trial will involve regular check-ups to assess the condition of the tendon and overall health. This includes looking at changes in pain, swelling, and other symptoms, as well as conducting tests like blood work and heart monitoring. The study aims to provide valuable information on whether NGI226 can be a safe and effective option for people suffering from Achilles tendinopathy.

1 initial visit and consent

Upon joining the study, you will have an initial visit where you will be asked to provide written informed consent. This means you agree to participate in the study after understanding all the details and potential risks.

During this visit, your eligibility will be confirmed based on specific criteria, such as age and the presence of Achilles tendinopathy diagnosed through clinical examination and imaging tests like ultrasound or MRI.

2 baseline assessments

You will undergo baseline assessments to evaluate your current health status. These assessments include laboratory tests, electrocardiogram (ECG), and vital signs measurements such as blood pressure and pulse rate.

Your tendon condition will be assessed using ultrasound-based shear wave elastography to measure tendon stiffness.

3 treatment administration

You will receive a single injection of either NGI226 microparticles or a placebo. The injection is administered near the affected tendon.

The injection is a powder mixed into a suspension for injection, and it is given through infiltration, which means it is injected directly into the area around the tendon.

4 follow-up visits

You will have regular follow-up visits to monitor your response to the treatment. These visits will include checking for any side effects, changes in pain, swelling, or other symptoms.

Additional assessments will be conducted to evaluate the safety and tolerability of the treatment, including laboratory tests and vital signs measurements.

5 final assessment

At the end of the study period, a final assessment will be conducted to evaluate the overall effects of the treatment on your tendon condition.

This will include a repeat of the ultrasound-based shear wave elastography to assess changes in tendon stiffness from the baseline.

Who Can Join the Study?

Must provide written informed consent before any study-specific procedures. This means you agree to participate after being informed about the study.
Must be an adult between 30 to 70 years old.
Must have Achilles tendinopathy, which is pain in the Achilles tendon, confirmed by a doctor through physical examination and imaging tests like ultrasound or MRI (Magnetic Resonance Imaging).
Symptoms must have been present for at least 8 weeks but less than 12 months.
Must have tried at least 6 weeks of conservative treatment without success. This includes methods like physiotherapy, taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), and using the RICE method (Rest, Ice, Compression, Elevation).

Who Cannot Join the Study?

Patients who have had surgery on their Achilles tendon in the past 6 months cannot participate.
Patients with a history of allergic reactions to similar treatments are not eligible.
Patients who are currently participating in another clinical trial are excluded.
Patients with severe medical conditions that could interfere with the study are not allowed to join.
Pregnant or breastfeeding women cannot take part in the study.
Patients who have received any other treatment for Achilles tendinopathy in the last 3 months are not eligible.
Patients with infections or skin conditions at the injection site are excluded.
Patients with a history of blood clotting disorders cannot participate.
Patients who are unable to follow the study procedures or attend follow-up visits are not eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Clinique De L’infirmerie Protestante De Lyon	Caluire Et Cuire	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Charite Research Organisation GmbH	Berlin	Germany
Orlfiyghxswh Hyazgii	Hamburg	Germany
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Ebokfry Ugnnaewxridj Mpiqavn Ccpwfyj Rzgthjosq (uckzvxd Mfy	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
France	Not recruiting	17.07.2023
Germany	Not recruiting	17.07.2023
The Netherlands	Not recruiting	17.07.2023

Trial locations

Investigated drugs:

Ngi226

NGI226 microparticles are tiny particles designed to help heal and regenerate tendons, specifically in patients with Achilles tendinopathy. This condition affects the tendon at the back of your ankle, causing pain and difficulty in movement. The microparticles are injected around the tendon to see if they can improve healing and reduce symptoms. The study aims to find out if this treatment is safe and how well it works in helping the tendon recover.

Investigated diseases:

Tendon disorder

Achilles Tendinopathy – Achilles tendinopathy is a condition that affects the Achilles tendon, which connects the calf muscles to the heel bone. It is characterized by pain, swelling, and stiffness in the tendon, particularly during physical activity. The condition often develops gradually, with symptoms worsening over time if not addressed. It is commonly seen in athletes and individuals who engage in activities that involve repetitive stress on the tendon. The progression of Achilles tendinopathy can lead to decreased flexibility and strength in the affected leg. In severe cases, it may result in difficulty walking or performing daily activities.

Trial ID:

2022-500863-10-00

Protocol code:

CNGI226A12201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of NGI226 Microparticles for Patients with Achilles Tendinopathy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?