Dupuytren Disease of FingerNCT07133945
Can the Number of Skin Tears be Reduced, by Prophylactic Treatment of the Skin in Dupuytrens Contracture Treated With Collagenase?
A study testing Silicone plaster or Steristrip or Vaseline in people with Dupuytren Disease of Finger, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Collagenase has gained pace in treating Dupuytrens contracture for some years. Thus this treatment is performed routinely in many orthopaedic and or hand surgical department. One of these benefits of the collagenase treatment is that the patients quickly recover and return to work or daily activities after the… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dupuytren Disease of Finger
- What is being tested?
- Silicone plaster or Steristrip or Vaseline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dupuytrens contracture
- Extension deficit of 30 degrees or more in the metacarpophangeal joint or the proximal interphalangeal joint
Who cannot join
- Previous treatment of the digit
Trial locations and contacts
1 site in 1 country.
About this study
Collagenase has gained pace in treating Dupuytrens contracture for some years. Thus this treatment is performed routinely in many orthopaedic and or hand surgical department. One of these benefits of the collagenase treatment is that the patients quickly recover and return to work or daily activities after the treatment. However, one of the often seen complications to the treatment is skin tear. This is reported in 20-80% of cases depending on the degree of contracture. The presence of skin tear leads to prolonged recovery, increased pain, scarring and post pone patients returning to daily activities and work. The investigators hypothesize that prophylactic initiatives with pre-existing products could reduce skin tear after treatment with collagenase injection into the Dupuytren cord.
Read the detailed description
To the knowledge of the investigators no effective measures exists for preventing skin breakage following collagenase treatment of Dupuytrens disease. In the current study three different skin treatments are tested against a control group to see if skin breakage can be reduced by one of these prophylactic measures.
The study is performed as a prospective randomized non blinded study.
The degree of contraction is measured. Injection of collagenase into the cord. According to randomization the patient will be allocated to one of the following four treatments.
- Standard treatment regime
- Standard treatment regime + vaseline on skin over the cord and the hand is wrapped in a plastic glove till next day
- Standard treatment regime + Silicone patch on skin over the cord and the hand is wrapped in a plastic glove till next day
- Standard treatment regime + Steristrips on skin over the cord and the hand is wrapped in a plastic glove till next day
- Conditions
- Dupuytren Disease of Finger
- Being tested
- Silicone plaster or Steristrip or Vaseline
- Keywords
- Collagenase, Xiapex, Vaseline, Steristrip, Silicone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone plaster or Steristrip or VaselineProcedure or surgery
Prophylatic treatment of the skin before breakage of the skin in dupuytrens disease
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | This group will receive standard collagenase injection in the cord |
| Experimental group | Experimental | This group will receive vaseline treatment, silicone plaster or steristrip on the skin overlying the cord before breakage of the cord Receives: Procedure: Silicone plaster or Steristrip or Vaseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear of skin
Does the skin tear when breaking the dupuytren cord? yes or no. There is no recognized scale for this observation. Only the registration of the skin tearing or not.
Measured: During breaking af dupuytren cord following collagenase treatment. Time frame is thus within approximately 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Jan 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren Disease of FingerStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133945
- Sponsor's protocol ID
- REG-185-2017
- Status last verified
- Dec 2018
- First submitted
- 6 Dec 2018
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Number of Skin Tears be Reduced, by Prophylactic Treatment of the Skin in Dupuytrens Contracture Treated With Collagenase?
- ClinicalTrials.gov ID
- NCT07133945
- Acronym / sponsor ID
- REG-185-2017
- Conditions
- Dupuytren Disease of Finger
- Keywords
- Collagenase, Xiapex, Vaseline, Steristrip, Silicone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Collagenase has gained pace in treating Dupuytrens contracture for some years. Thus this treatment is performed routinely in many orthopaedic and or hand surgical department. One of these benefits of the collagenase treatment is that the patients quickly recover and return to work or daily activities after the treatment. However, one of the often seen complications to the treatment is skin tear. This is reported in 20-80% of cases depending on the degree of contracture. The presence of skin tear leads to prolonged recovery, increased pain, scarring and post pone patients returning to daily activities and work. The investigators hypothesize that prophylactic initiatives with pre-existing products could reduce skin tear after treatment with collagenase injection into the Dupuytren cord.
Detailed description
To the knowledge of the investigators no effective measures exists for preventing skin breakage following collagenase treatment of Dupuytrens disease. In the current study three different skin treatments are tested against a control group to see if skin breakage can be reduced by one of these prophylactic measures.
The study is performed as a prospective randomized non blinded study.
The degree of contraction is measured. Injection of collagenase into the cord. According to randomization the patient will be allocated to one of the following four treatments.
- Standard treatment regime
- Standard treatment regime + vaseline on skin over the cord and the hand is wrapped in a plastic glove till next day
- Standard treatment regime + Silicone patch on skin over the cord and the hand is wrapped in a plastic glove till next day
- Standard treatment regime + Steristrips on skin over the cord and the hand is wrapped in a plastic glove till next day
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –This group will receive standard collagenase injection in the cord |
| Experimental group | Experimental | Procedure: Silicone plaster or Steristrip or VaselineThis group will receive vaseline treatment, silicone plaster or steristrip on the skin overlying the cord before breakage of the cord |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dupuytrens contracture
- Extension deficit of 30 degrees or more in the metacarpophangeal joint or the proximal interphalangeal joint
Key exclusion criteria (1 listed)
- Previous treatment of the digit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silicone plaster or Steristrip or VaselineProphylatic treatment of the skin before breakage of the skin in dupuytrens disease | Procedure or surgery | Experimental group |
Primary outcome
Tear of skin
Time frame: During breaking af dupuytren cord following collagenase treatment. Time frame is thus within approximately 10 seconds
Does the skin tear when breaking the dupuytren cord? yes or no. There is no recognized scale for this observation. Only the registration of the skin tearing or not.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone plaster or Steristrip or Vaseline in people with Dupuytren Disease of Finger, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear of skin (time frame: During breaking af dupuytren cord following collagenase treatment. Time frame is thus within approximately 10 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.