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Registry of Dupuytren's Contracture Treatment Outcomes (ReDuCTO)

T

Technische Universität Dresden

Status

Completed

Conditions

Dupuytren's Disease

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01567397
ReDuCTO ID 7090

Details and patient eligibility

About

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

Enrollment

87 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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