Registry of Dupuytren's Contracture Treatment Outcomes

Completed

• Conditions: Dupuytren's Disease

• Registration Number: NCT01567397
• Lead Sponsor: Technische Universität Dresden

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-03-28
• Study First Submitted QC: 2012-03-29
• Study First Posted: 2012-03-30
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Several undisclosed sites; 🇩🇪 Various cities, Germany

Prof. Dr. Max Haerle; 🇩🇪 Markgröningen, Germany

Prof. Dr. Riccardo Giunta; 🇩🇪 Munich, Germany

Dr. Joerg Witthaut; 🇩🇪 Vogtareuth, Germany