Dupuytrens ContractureNCT01538017
Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture
A study testing Xiapex and Percutaneous needle fasciotomy in people with Dupuytrens Contracture, run by Jeppe Lange, MD at 1 site in Denmark.
Trial summary
Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's contracture affecting proximal interphalangeal joints. An open label, medico-independent randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dupuytrens Contracture
- What is being tested?
- Xiapex and Percutaneous needle fasciotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2012to Oct 2016
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DC affecting PIP joint with Passive Extension Deficit (PED) more than 20 degrees
- Clearly defined strings
Who cannot join
- Allergies to used medication
- International Normalised Ratio more than 2.0
- Pregnancy and breastfeeding
- Previous treatment for DC in affected finger
- Former inclusion in the study with another string
- Activity in disease at time of study
- PED more than 20 degrees for Metacarpophalangeal or Distal Interphalangeal joint in affected digit
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Planned surgery - Regionalhospital Silkeborg
Silkeborg, 8600
About this study
Official title: Comparing Injectable Collagenase (CI) and Percutaneous Needle Fasciotomy (PNF) for Dupuytren's Contracture (DC) Affecting Proximal Interphalangeal Joints (PIP). A Randomised Controlled Trial
Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's contracture affecting proximal interphalangeal joints. An open label, medico-independent randomized controlled trial.
- Conditions
- Dupuytrens Contracture
- Being tested
- Xiapex, Percutaneous needle fasciotomy
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XiapexDrug
Also called XIAPEX® - Pfizer UK
Collagenase Clostridium Histolyticum
Percutaneous needle fasciotomyProcedure or surgery
Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre
| Study group | Role | What they receive |
|---|---|---|
| Collagenase injection | Active comparator | Injection of collagenase obtained from Clostridium Histolyticum in contracture string Receives: Drug: Xiapex |
| Percutaneous needle fasciotomy | Active comparator | PNF ad modum Lermusiaux and Debeyre Receives: Procedure: Percutaneous needle fasciotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
Clinical improvement is defined as a contracture reduction 50% or more from baseline.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytrens ContractureStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeppe Lange, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeppe Lange, MD, Regionshospitalet Silkeborg
- Investigators
- Jeppe Lange, M.D., Study director, Regionshospitalet Silkeborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538017
- Sponsor's protocol ID
- M-20110233
- Status last verified
- Oct 2016
- First submitted
- 18 Feb 2012
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Injectable Collagenase (CI) and Percutaneous Needle Fasciotomy (PNF) for Dupuytren's Contracture (DC) Affecting Proximal Interphalangeal Joints (PIP). A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01538017
- Acronym / sponsor ID
- M-20110233
- Conditions
- Dupuytrens Contracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jeppe Lange, MDUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Feb 2012 (estimated)
- 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.
Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's contracture affecting proximal interphalangeal joints. An open label, medico-independent randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagenase injection | Active comparator | Drug: XiapexInjection of collagenase obtained from Clostridium Histolyticum in contracture string |
| Percutaneous needle fasciotomy | Active comparator | Procedure: Percutaneous needle fasciotomyPNF ad modum Lermusiaux and Debeyre |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DC affecting PIP joint with Passive Extension Deficit (PED) more than 20 degrees
- Clearly defined strings
Key exclusion criteria (7 listed)
- Allergies to used medication
- International Normalised Ratio more than 2.0
- Pregnancy and breastfeeding
- Previous treatment for DC in affected finger
- Former inclusion in the study with another string
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 |
|---|---|---|
| XiapexAlso: XIAPEX® - Pfizer UKCollagenase Clostridium Histolyticum | Drug | Collagenase injection |
| Percutaneous needle fasciotomyPercutaneous needle fasciotomy ad modum Lermusiaux and Debeyre | Procedure or surgery | Percutaneous needle fasciotomy |
Primary outcome
Clinical improvement
Time frame: 2 years
Clinical improvement is defined as a contracture reduction 50% or more from baseline.
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 4 Oct 2016.
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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.
Jeppe Lange, M.D. study director
Regionshospitalet Silkeborg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xiapex and Percutaneous needle fasciotomy in people with Dupuytrens Contracture, run by Jeppe Lange, MD 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 7 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 4 Oct 2016. 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?
Clinical improvement (time frame: 2 years). 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 4 Oct 2016.