Not recruiting

Study on the Effectiveness of Collagenase, Percutaneous Needle Fasciotomy, and Limited Fasciectomy for Patients with Mild or Moderate Dupuytren's Contracture

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of different treatments for Dupuytren's contracture, a condition where the fingers bend towards the palm and cannot be fully straightened. The study will compare three treatment methods: collagenase clostridium histolyticum (a medication that helps break down the tough tissue causing the contracture), percutaneous needle fasciotomy (a procedure where a needle is used to cut the cord of tissue causing the contracture), and limited fasciectomy (a surgical procedure to remove the affected tissue).

The purpose of the study is to determine which treatment strategy is the most effective and cost-efficient over a five-year period. Participants will be randomly assigned to one of the three treatment groups. Some participants will receive the collagenase injection, while others will undergo the needle procedure or surgery. The study will follow participants to see how well each treatment works in the short and long term.

Throughout the study, participants will be monitored to assess the success of the treatment they receive. The study aims to provide valuable information on the best approach to managing Dupuytren's contracture, helping to improve treatment options for this condition in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, eligibility is confirmed based on specific criteria such as having a certain degree of finger joint stiffness, being over 18 years old, and providing consent.
Participants must be able to complete questionnaires in Finnish.
Step 2
Treatment assignment
Participants are randomly assigned to one of three treatment groups: collagenase injection, percutaneous needle fasciotomy, or limited fasciectomy.
Step 3
Collagenase injection
For those in the collagenase group, the treatment involves an injection of collagenase into the affected area.
The frequency and dosage are determined by the medical team based on individual needs.
Step 4
Percutaneous needle fasciotomy
Participants in this group undergo a procedure where a needle is used to cut the cord causing the finger stiffness.
Step 5
Limited fasciectomy
This group receives a surgical procedure to remove the tissue causing the contracture.
Step 6
Follow-up and assessment
Participants are monitored over a period of five years to assess the success of the treatment.
Regular follow-up visits are scheduled to evaluate progress and any need for additional treatment.
Step 7
End of trial
The trial is expected to conclude by the end of 2032, with final assessments conducted to determine the most effective treatment strategy.

Who can join the trial?

5 criteria

Patients must have a combined bending problem of at least 20 degrees in the joints of fingers II to V. This means the fingers can't fully straighten.
Patients must be older than 18 years.
Patients must have a **palpable cord**, which is a thickened tissue under the skin of the palm that can be felt.
Patients must agree to participate by providing **informed consent**, which means they understand the study and agree to take part.
Patients must be able to complete questionnaires in Finnish.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with Dupuytren's contracture cannot participate. Dupuytren's contracture is a condition where the fingers bend towards the palm and cannot be fully straightened.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Helsinki University Central Hospital
Helsinki, Finland
Verified
Kuopio University Hospital
Kuopio, Finland
Verified
Oulu University Hospital
Oulu, Finland

Trial locations

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Investigated drugs

Collagenase Clostridium Histolyticum
is an enzyme injection used to treat Dupuytren's contracture. It works by breaking down the collagen buildup in the hand, which can help to release the fingers and improve movement. This treatment is less invasive than surgery and is used as a primary treatment option in the trial.
Percutaneous Needle Fasciotomy
is a minimally invasive procedure used to treat Dupuytren's contracture. In this procedure, a needle is used to cut the thickened tissue in the palm, allowing the fingers to straighten. It is considered a primary treatment option in the trial and is followed by surgery if necessary.
Limited Fasciectomy
is a surgical procedure used to treat Dupuytren's contracture. During this surgery, the surgeon removes the thickened tissue in the hand to improve finger movement. It is used as both a primary and secondary treatment option in the trial, especially for patients who do not respond to other treatments.

Collagenase

What is already known about the treatment

Collagenase Clostridium Histolyticum – This medication is administered through an injection directly into the affected area. It is currently recognized in medical literature as a treatment for Dupuytren's contracture, a condition that affects the hands. The main therapeutic indication is to improve finger movement by breaking down the collagen buildup that causes the contracture. At the molecular level, it works by enzymatically cleaving collagen, which helps to reduce the thickened tissue. It is classified pharmacologically as a collagenase enzyme.

Investigated diseases

Dupuytren's contracture – Dupuytren's contracture is a hand condition where the fingers bend towards the palm due to thickening and shortening of the tissue beneath the skin. It typically starts with small lumps or nodules in the palm, which may gradually develop into thick cords. Over time, these cords can pull one or more fingers into a bent position, making it difficult to straighten them. The condition usually progresses slowly and can vary in severity. It most commonly affects the ring and little fingers and is more prevalent in older adults. The exact cause is unknown, but it is believed to involve genetic factors.