Registry of Dupuytren's Contracture Treatment Outcomes

NCT ID: NCT01567397

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Dupuytren's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* palpable cord due to Dupuytren's Disease (pretreated or untreated)
* satisfactory knowledge of German to be able to fill out questionnaires
* written informed consent

Exclusion Criteria

* contraindication to Microbial Collagenase (according to Prescription Information)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GWT-TUD GmbH

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Pittrow, MD, PhD

Role: STUDY_DIRECTOR

Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany

Wilhelm Kirch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Clinical Pharmacology (Director), Medical Faculty, Technical University, Dresden, Germany

Max Härle, MD

Role: STUDY_DIRECTOR

Orthopädische Klinik, Markgröningen, Germany

Jörg Witthaut, MD

Role: STUDY_DIRECTOR

Schön Klinik Vogtareuth

Riccardo Giunta, MD

Role: STUDY_DIRECTOR

Hand Surgery, Ludwig-Maximilian-University Munich, Germany

Locations

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Prof. Dr. Max Haerle

Markgröningen, , Germany

Site Status

Prof. Dr. Riccardo Giunta

Munich, , Germany

Site Status

Several undisclosed sites

Various Cities, , Germany

Site Status

Dr. Joerg Witthaut

Vogtareuth, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.egms.de/static/de/journals/gpras/2015-5/gpras000034.shtml

Publication of results in the German Mecial Science (GMS) database

Other Identifiers

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ReDuCTO ID 7090

Identifier Type: -

Identifier Source: org_study_id