Study on the Safety and Effectiveness of Vibrio Alginolyticus Collagenase for Patients with Dupuytren’s Contracture

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What is this study about?

This clinical trial is focused on studying a condition known as Dupuytren’s contracture. This condition affects the hands, causing one or more fingers to bend towards the palm due to a thickening of the tissue under the skin. The study is testing a treatment called Vibrio alginolyticus collagenase, which is a type of enzyme that breaks down proteins. This enzyme is injected directly into the affected area to help reduce the contracture, or bending, of the fingers.

The purpose of the study is to evaluate the safety and effectiveness of this treatment. The study is divided into two phases. In the first phase, different doses of the enzyme will be tested to find the safest and most effective dose. In the second phase, the dose identified in the first phase will be used to see how well it works in a larger group of patients. Some participants will receive the enzyme, while others will receive a matching placebo, which looks like the treatment but does not contain the active enzyme.

Participants in the study will receive up to three injections of the enzyme into the affected area. The study will monitor the participants to see if the treatment helps reduce the bending of the fingers and improves hand function. The study will also check for any side effects or immune reactions to the enzyme. The goal is to determine if Vibrio alginolyticus collagenase is a safe and effective treatment option for people with Dupuytren’s contracture.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will receive detailed information about the study, including its purpose, procedures, and potential risks and benefits. You will be asked to provide your signed informed consent, confirming your understanding and willingness to participate.

Your eligibility will be confirmed based on specific criteria, such as age, diagnosis of Dupuytren contracture, and ability to comply with study requirements.

2 phase I treatment

In Phase I, you will receive a single injection of Vibrio alginolyticus collagenase directly into the affected cord of your finger. The purpose of this phase is to evaluate the safety and tolerability of different doses.

You will be monitored closely for any side effects or reactions to the injection. The goal is to identify the maximum dose that can be tolerated without significant side effects.

3 phase I follow-up

Approximately 30 days after the injection, your finger’s range of motion and contracture degree will be assessed. This will help determine the effectiveness of the treatment.

Blood samples may be taken to measure the levels of the drug in your system and to check for any immune response.

4 phase II treatment

In Phase II, you may receive up to three injections of the dose identified as safe in Phase I. These injections will also be administered directly into the affected cord.

The aim of this phase is to evaluate the effectiveness of the treatment in reducing the contracture of your finger.

5 phase II follow-up

Your progress will be monitored for approximately 30 days after the last injection. The degree of contracture and range of motion will be measured to assess clinical success.

Additional blood samples may be collected to evaluate the drug’s presence in your system and any immune response.

6 long-term follow-up

Six months after the last injection, a follow-up assessment will be conducted to evaluate the long-term effects of the treatment.

The degree of contracture, range of motion, and any recurrence of symptoms will be measured. Blood samples may be taken to assess the safety and immune response over time.

Who Can Join the Study?

Sign a written form to show you understand and agree to take part in the study.
Be a man or woman who is at least 18 years old.
Have a diagnosis of Dupuytren contracture, which means your finger is bent at an angle between 20° and 100° if it’s in the main joint (MP) or between 20° and 80° if it’s in the middle joint (PIP) of at least one finger, not including the thumb. This is caused by a cord that can be felt under the skin and might be helped by the treatment.
Be able to fully understand the study, including any risks and side effects, and be able to work with the study team and follow all study requirements.
If you are a woman who can have children, you must use at least one reliable method of birth control, such as:
- Hormonal birth control pills, implants, patches, or injections for at least 2 months before the study starts.
- A non-hormonal device like an intrauterine device (IUD) or female condom with spermicide, contraceptive sponge with spermicide, diaphragm with spermicide, or cervical cap with spermicide for at least 2 months before the study starts.
- A male partner who agrees to use a condom with spermicide.
- A partner who is unable to have children (sterile).
- Choosing not to have sex (abstinence).
Women who cannot have children or have not had a period for at least 1 year can also participate. All women who can have children must have a negative pregnancy test before starting the study and on the first day of the study.

Who Cannot Join the Study?

Patients with any other medical condition that might interfere with the study.
Patients who have had a recent surgery or procedure on the affected hand.
Patients who are currently participating in another clinical trial.
Patients who have an allergy to the study medication or its ingredients.
Patients who are pregnant or breastfeeding.
Patients with a history of severe allergic reactions.
Patients who have a significant infection in the affected hand.
Patients who have a history of bleeding disorders.
Patients who are taking medications that affect blood clotting.
Patients who have a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Graz	Graz	Austria

Other Sites

Site Name	City	Country
Noe LGA Gesundheit Region Mitte GmbH	St. Poelten	Austria
San Camillo Forlanini Hospital	Rome	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Hpaskm Kydkhhng Bpktefslriumzns	Bonn	Germany
Udrjemc Uogogfugci Hqohtbot	Uppsala	Sweden
Ajprcnb Ogsnoclmnyt Unrsjstmkjfrz Couowkwuniuv Dvdbh Sfntyf E Dspze Sgaapoe Df Tssgqf	Turin	Italy

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.09.2024
Germany	Recruiting	01.09.2024
Italy	Recruiting	01.09.2024
Sweden	Recruiting	01.09.2024

Trial locations

Investigated drugs:

Vibrio Alginolyticus Collagenase

Vibrio alginolyticus collagenase is a medication being studied for its potential to treat Dupuytren contracture, a condition that affects the hands and fingers. This medication is injected directly into the affected area, where it works by breaking down the collagen in the cords that cause the fingers to bend towards the palm. The goal of the treatment is to help straighten the fingers and improve hand function. The study is looking at how safe and effective this medication is, as well as how the body processes it and whether it causes any immune reactions.

Investigated diseases:

Dupuytren's contracture

Dupuytren contracture – Dupuytren contracture is a hand condition that affects the connective tissue under the skin of the palm and fingers. It begins with the thickening of the tissue, forming nodules or lumps. Over time, these nodules can develop into cords that pull one or more fingers into a bent position. The progression is usually slow, occurring over several years. As the condition advances, it can limit the ability to straighten the fingers, affecting hand function. The ring and little fingers are most commonly affected, but it can occur in any finger.

Trial ID:

2023-507332-20-00

Protocol code:

RR37_23_01

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Vibrio Alginolyticus Collagenase for Patients with Dupuytren’s Contracture

What is this study about?

Who Can Join the Study?

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