Dupuytren's DiseaseReDuCTONCT01567397
Registry of Dupuytren's Contracture Treatment Outcomes
An observational study of Dupuytren's Disease, run by Technische Universität Dresden at 4 sites in Germany.
Trial summary
Experience with Microbial Collagenase (trade name Xiapex) in Europe currently is limited to randomised controlled studies.While such studies are essential to determine efficacy and safety of the product (usually compared to placebo), they provide no information on the effectiveness of the drug and further aspects of… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dupuytren's Disease
- How many people
- 87 participants
- Where
- 4 sitesGermany
- Study dates
- Dec 2011to Apr 2013
- Phase
- Observational
- 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
Study population: Patients with Dupuytren's Disease
Who may be able to join
- palpable cord due to Dupuytren's Disease (pretreated or untreated)
- satisfactory knowledge of German to be able to fill out questionnaires
- written informed consent
Who cannot join
- contraindication to Microbial Collagenase (according to Prescription Information)
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Prof. Dr. Max Haerle
Markgröningen
Prof. Dr. Riccardo Giunta
Munich
Several undisclosed sites
Various Cities
Dr. Joerg Witthaut
Vogtareuth
About this study
Experience with Microbial Collagenase (trade name Xiapex) in Europe currently is limited to randomised controlled studies.While such studies are essential to determine efficacy and safety of the product (usually compared to placebo), they provide no information on the effectiveness of the drug and further aspects of its use (feasibility, tolerability, quality of life and other patient-related outcomes) in the typical "real-life" setting under clinical practice conditions.Thus, the present study aims to collect data on the
- Drug utilization of Microbial Collagenase in the hand of physicians, with focus on feasibility, treatment patterns, and effectiveness in clinical practice
- Context of Microbial Collagenase therapy (setting, patient characteristics, concomitant treatment, follow-up therapy)
- Effectiveness (with focus on functionality)
- Tolerability
- Patient-related outcomes: patient satisfaction, health-related quality of life
- Physician satisfaction with therapy
- Resource utilization (hospital stays, drug consumption, concomitant medication etc.)
- Long-term outcomes
- Conditions
- Dupuytren's Disease
- Medical subject headings
- Dupuytren Contracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren's DiseaseStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- GWT-TUD GmbH, Pfizer
- Responsible party
- Sponsor
- Investigators
- David Pittrow, MD, PhD, Study director, Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, GermanyWilhelm Kirch, MD, PhD, Principal investigator, Institute for Clinical Pharmacology (Director), Medical Faculty, Technical University, Dresden, GermanyMax Härle, MD, Study director, Orthopädische Klinik, Markgröningen, GermanyJörg Witthaut, MD, Study director, Schön Klinik VogtareuthRiccardo Giunta, MD, Study director, Hand Surgery, Ludwig-Maximilian-University Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567397
- Sponsor's protocol ID
- ReDuCTO ID 7090
- Acronym
- ReDuCTO
- Status last verified
- Dec 2016
- First submitted
- 28 Mar 2012
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Dupuytren's Contracture Treatment Outcomes
- ClinicalTrials.gov ID
- NCT01567397
- Acronym / sponsor ID
- ReDuCTO / ReDuCTO ID 7090
- Conditions
- Dupuytren's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- GWT-TUD GmbH, Pfizer
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 30 Mar 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.
Experience with Microbial Collagenase (trade name Xiapex) in Europe currently is limited to randomised controlled studies.While such studies are essential to determine efficacy and safety of the product (usually compared to placebo), they provide no information on the effectiveness of the drug and further aspects of its use (feasibility, tolerability, quality of life and other patient-related outcomes) in the typical "real-life" setting under clinical practice conditions.Thus, the present study aims to collect data on the
- Drug utilization of Microbial Collagenase in the hand of physicians, with focus on feasibility, treatment patterns, and effectiveness in clinical practice
- Context of Microbial Collagenase therapy (setting, patient characteristics, concomitant treatment, follow-up therapy)
- Effectiveness (with focus on functionality)
- Tolerability
- Patient-related outcomes: patient satisfaction, health-related quality of life
- Physician satisfaction with therapy
- Resource utilization (hospital stays, drug consumption, concomitant medication etc.)
- Long-term outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Dupuytren's Disease
Key inclusion criteria (3 listed)
- palpable cord due to Dupuytren's Disease (pretreated or untreated)
- satisfactory knowledge of German to be able to fill out questionnaires
- written informed consent
Key exclusion criteria (1 listed)
- contraindication to Microbial Collagenase (according to Prescription Information)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 22 Dec 2016.
- Publication of results in the German Mecial Science (GMS) databaseLink provided by the sponsor.
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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.
David Pittrow, MD, PhD study director
Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany
Wilhelm Kirch, MD, PhD principal investigator
Institute for Clinical Pharmacology (Director), Medical Faculty, Technical University, Dresden, Germany
Max Härle, MD study director
Orthopädische Klinik, Markgröningen, Germany
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dupuytren's Disease, run by Technische Universität Dresden at 4 sites in Germany.
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 3 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 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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.
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 22 Dec 2016.