Registry of Dupuytren's Contracture Treatment Outcomes

Dupuytren's Disease Clinical Trial

— ReDuCTO  

Official title:

Registry of Dupuytren's Contracture Treatment Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01567397
• Other study ID #: ReDuCTO ID 7090
• Status: Completed
• Phase: N/A
• First received: March 28, 2012
• Last updated: December 20, 2016
• Start date: December 2011
• Est. completion date: April 2013

Study information

• Verified date: December 2016
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethikkommission an der TU Dresden
• Study type: Observational

Clinical 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytren's Disease

Locations

Country	Name	City	State
Germany	Prof. Dr. Max Haerle	Markgröningen
Germany	Prof. Dr. Riccardo Giunta	Munich
Germany	Several undisclosed sites	Various cities
Germany	Dr. Joerg Witthaut	Vogtareuth

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität Dresden	GWT-TUD GmbH, Pfizer

Country where clinical trial is conducted

Germany, 

External Links

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