Post Approval Commitment Study

A Non-Interventional Post Approval Commitment Study To Evaluate The Outcomes Of The Various Treatment Options For Dupuytren's Contracture

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01444729

Enrollment

305

Registered

2011-10-03

Start date

2012-03-31

Completion date

2015-11-30

Last updated

2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytren's Contracture

Keywords

'Dupuytren's contracture', 'xiapex', 'surgery'

Brief summary

An agreement has been made to conduct a post-approval commitment study that provides supplementary information relating to the use of Xiapex® as well as other non-pharmacological treatments for Dupuytren's contracture by health care professionals in a real world clinical setting.

Detailed description

phase 4, open label, multi-center, prospective non-interventional descriptive

Interventions

DRUGXiapex

Xiapex administration will follow SMPC

PROCEDUREsurgery

Non-pharmacological treatment

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adults with a palpable cord eligible for the treatment of Dupuytren's contracture

Exclusion criteria

none

Design outcomes

Primary

Measure	Time frame
clinical treatment success as assessed by goniometry	an expected average of 5 weeks
treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires	an expected average of 5 weeks

Secondary

Measure	Time frame
Treatment option as determined by treating physician in consultation with patient	at day 1

Countries

Norway, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026