In short
Dupuytren's contracture is a hand condition that causes fingers to bend towards the palm, making them difficult to straighten. Currently, there are 4 clinical trials underway testing different treatment approaches, including enzyme injections, minimally invasive needle procedures, anti-inflammatory medications, and surgical options. These trials are being conducted in several European countries, aiming to find the most effective and safest ways to treat this progressive hand condition. (Also known as: Dupuytren Disease, Dupuytren Contracture)
Clinical trial locations
- Austria
- Belgium
- Denmark
- Finland
- Germany
- Italy
- Sweden
Study on Percutaneous Needle Fasciotomy with Methylprednisolone Acetate or Saline for Dupuytren's Contracture in the Finger Joint
This Danish trial is investigating whether adding a corticosteroid injection to a minimally invasive needle procedure can provide better long-term results for patients with finger joint contractures.
Main inclusion criteria:
- Participants must be at least 45 years old
- Must have a finger (index, middle, ring, or little finger) that cannot fully straighten, with at least 20 degrees of bending at the knuckle closest to the palm
- Must have a well-defined or easily felt cord in the palm or finger
- Must provide written informed consent after receiving both oral and written information about the trial
Main exclusion criteria:
- Recent surgery for the condition in the past 6 months
- Other hand conditions that affect movement or function
- Corticosteroid injection in the affected hand within the last 3 months
- Known allergy to corticosteroids or injection components
- Active infection in the hand or arm
- Pregnancy or breastfeeding
- History of poor wound healing or significant scarring
- Unable to attend required follow-up visits
Treatment approach: The trial uses Percutaneous Needle Fasciotomy (PNF), a procedure where a needle is used to cut the thickened tissue causing the finger to bend. Participants are randomly assigned to receive either a corticosteroid injection (Depo-Medrol combined with lidocaine, a local anesthetic) or a simple saline injection after the procedure. The corticosteroid aims to reduce inflammation and potentially prevent the condition from returning.
Study goal: The main purpose is to determine whether combining the needle procedure with corticosteroid injection leads to better long-term outcomes and lower recurrence rates compared to the procedure alone. Participants will be monitored over time to assess improvements in hand function, finger straightening ability, and any complications or side effects.
Study on the Effectiveness of Collagenase, Percutaneous Needle Fasciotomy, and Limited Fasciectomy for Patients with Mild or Moderate Dupuytren's Contracture
This Finnish trial is comparing three different treatment methods to determine which is most effective and cost-efficient over a five-year period for patients with mild to moderate contractures.
Main inclusion criteria:
- Must be older than 18 years
- Must have a combined bending problem of at least 20 degrees in the finger joints, meaning the fingers cannot fully straighten
- Must have a palpable cord (thickened tissue that can be felt under the skin)
- Must be able to complete questionnaires in Finnish
- Must provide informed consent
Main exclusion criteria:
- Not diagnosed with the condition
- Outside the specified age range
- Part of a vulnerable population with limited ability to give informed consent or at higher risk of harm
Treatment options: Participants are randomly assigned to one of three groups. The first group receives collagenase clostridium histolyticum injections, which help break down the tough tissue causing the contracture. The second group undergoes percutaneous needle fasciotomy, where a needle cuts the tissue cord. The third group receives limited fasciectomy, a surgical procedure to remove the affected tissue.
Study goal: The trial aims to determine which treatment strategy provides the best outcomes over five years, considering both effectiveness and cost-efficiency. Participants will be monitored with regular follow-up visits to evaluate progress and assess whether additional treatment is needed. The study is expected to conclude by the end of 2032.
Study on the Safety and Effectiveness of Vibrio Alginolyticus Collagenase for Patients with Dupuytren's Contracture
This international trial, conducted in Italy, Austria, Sweden, and Germany, is testing a new type of enzyme injection that breaks down the proteins causing finger contractures.
Main inclusion criteria:
- Must be at least 18 years old
- Must have a diagnosis with finger bent at an angle between 20° and 100° in the main joint or between 20° and 80° in the middle joint of at least one finger (excluding the thumb)
- Must have a cord that can be felt under the skin
- Must be able to understand the study, including risks and side effects, and follow all requirements
- Women of childbearing potential must use reliable birth control methods for at least 2 months before the study starts and have a negative pregnancy test
- Must provide written informed consent
Main exclusion criteria:
- Any medical condition that might interfere with the study
- Recent surgery or procedure on the affected hand
- Currently participating in another clinical trial
- Allergy to the study medication or its ingredients
- Pregnancy or breastfeeding
- History of severe allergic reactions
- Significant infection in the affected hand
- History of bleeding disorders
- Taking medications that affect blood clotting
- History of drug or alcohol abuse
Treatment approach: The trial uses Vibrio alginolyticus collagenase, an enzyme injected directly into the affected area to break down the collagen in the cords pulling the fingers toward the palm. The study is conducted in two phases. Phase I tests different doses to find the safest and most effective amount. Phase II uses the dose identified in Phase I with a larger group of patients, where some receive the enzyme and others receive a placebo.
Study goal: The main objective is to evaluate whether this enzyme treatment is safe and effective in straightening fingers and improving hand function. Participants may receive up to three injections and will be monitored for side effects, immune reactions, and improvements in finger movement. Follow-up assessments continue for six months after the last injection to evaluate long-term effects.
Study on the Effects of Adalimumab and Saline in Patients Undergoing Needle Fasciotomy for Dupuytren's Disease
This Belgian trial is investigating whether an anti-inflammatory medication called Adalimumab can improve outcomes when combined with needle fasciotomy.
Main inclusion criteria:
- Must be at least 18 years old
- Must be diagnosed with the disease and eligible for fasciotomy (a procedure that cuts the thickened tissue)
- Must have joint contractures in the finger joints that are not fixed, meaning the joints are bent but can still be moved
- Must have a diathesis score of at least 4 (a measure doctors use to assess severity)
- Must provide voluntary written informed consent
Main exclusion criteria:
- Not within the specified age range
- Have medical conditions other than Dupuytren Disease
- Part of a vulnerable population requiring special protection or care
- Not eligible for anti-TNF medication treatment
Treatment approach: Adalimumab is a biologic medication that blocks a protein called tumor necrosis factor (TNF), which plays a role in inflammation. Participants are randomly assigned to receive either Adalimumab or a placebo (saline) through injection. The medication is given under the skin, typically in the thigh or abdomen, according to a specific schedule determined by the study team.
Study goal: The trial aims to determine whether adding Adalimumab to needle fasciotomy leads to better outcomes, including improved finger straightening, reduced recurrence rates, lower pain levels, and greater patient satisfaction. Throughout the study, progress is monitored using various measures, including visual analogue scales for pain and satisfaction. The study is expected to end by March 18, 2025.
Summary
The four ongoing clinical trials for Dupuytren's contracture reflect diverse treatment approaches across several European countries. Two trials focus on enzyme injections to break down the collagen cords causing finger contractures—one testing collagenase clostridium histolyticum in Finland and another evaluating Vibrio alginolyticus collagenase across multiple countries including Italy, Austria, Sweden, and Germany.
Two trials investigate combining minimally invasive needle procedures with anti-inflammatory treatments. The Danish study examines whether adding corticosteroid injections to percutaneous needle fasciotomy reduces recurrence rates, while the Belgian trial tests whether Adalimumab, a biologic medication, improves outcomes when combined with needle fasciotomy.
The Finnish trial stands out for its comprehensive comparison of three treatment strategies—enzyme injection, needle procedure, and surgical removal of affected tissue—with a five-year follow-up period to assess long-term effectiveness and cost-efficiency. This extended timeline provides valuable information about treatment durability.
All trials require participants to be adults with confirmed diagnoses and measurable contractures, typically ranging from 20 to 100 degrees of finger bending. Common exclusion criteria include recent hand surgery, active infections, pregnancy, and allergies to study medications. Most trials emphasize the importance of participants' ability to attend follow-up visits and provide informed consent.
The geographic distribution shows particular concentration in Nordic countries (Denmark, Finland, Sweden) and Central Europe (Germany, Austria), with additional representation in Italy and Belgium. This suggests active research interest in these regions for finding optimal treatment approaches for this progressive hand condition.
