Registry of Dupuytren's Contracture Treatment Outcomes

NCT01567397 | Completed

• 1 other identifier: ReDuCTO ID 7090
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 4

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

Conditions

Dupuytren's Disease

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Dupuytren's Disease

You may qualify if:

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

You may not qualify if:

• contraindication to Microbial Collagenase (according to Prescription Information)

Sponsors & Collaborators

• Technische Universität Dresden: lead
• GWT-TUD GmbH: collaborator
• Pfizer: collaborator

Study Sites (4)

Prof. Dr. Max Haerle

Markgröningen, Germany

Location

Prof. Dr. Riccardo Giunta

Munich, Germany

Location

Several undisclosed sites

Various Cities, Germany

Location

Dr. Joerg Witthaut

Vogtareuth, Germany

Location

Related Links

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

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Pittrow, MD, PhD

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

  STUDY DIRECTOR

• Wilhelm Kirch, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Max Härle, MD

  Orthopädische Klinik, Markgröningen, Germany

  STUDY DIRECTOR

• Jörg Witthaut, MD

  Schön Klinik Vogtareuth

  STUDY DIRECTOR

• Riccardo Giunta, MD

  Hand Surgery, Ludwig-Maximilian-University Munich, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: March 30, 2012
• Study Start: December 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

DE (4)