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

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What is this study about?

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.

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.

2 treatment assignment

Participants are randomly assigned to one of three treatment groups: collagenase injection, percutaneous needle fasciotomy, or limited fasciectomy.

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.

4 percutaneous needle fasciotomy

Participants in this group undergo a procedure where a needle is used to cut the cord causing the finger stiffness.

5 limited fasciectomy

This group receives a surgical procedure to remove the tissue causing the contracture.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Kuopio University Hospital Kuopio Finland

Other Sites

Site Name City Country Status
Oulu University Hospital Oulu Finland
Central Finland Hospital District Central Finland Hospital Nova Jyvaskyla Finland
Turku University Hospital Turku Finland
Pirkanmaan hyvinvointialue Tampere Finland
Hbxnerjb Uoogdwdnwt Cbamekr Hnaimrki Helsinki Finland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Not recruiting
01.09.2017

Trial locations

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.

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.

Trial ID:
2024-515110-40-00
Protocol code:
DETECT
Trial Phase:
Therapeutic confirmatory (Phase III)

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