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CompletedNCT03331926Updated Apr 22, 2020

Collagenase is a Common Treatment of MCP and PIP Joint Contractures in Dupuytrens Disease

An observational study in Dupuytren Contracture, sponsored by Jeppe Lange. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-22.

Sponsored by Jeppe Lange · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
199
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the effect of collagenase clostridium histolyticum treatment at the Department of Orthopaedic surgery at Horsens Regional Hospital after minimum one-year follow-up (FU).

02

Conditions studied

  • Dupuytren Contracture

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03

In context

Dupuytren Contracture

78 studies on the registry are indexed under Dupuytren Contracture; 18 are open to participants now.

This study's enrollment of 199 is above the median of 80 across 19 observational studies indexed under Dupuytren Contracture.

Browse Dupuytren Contracture studies →

Lead sponsor

Jeppe Lange is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All patients who received Xiapex treatment in Horsens from 2013 to May 2016 with a least 1 years of followup.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • dupuytrens disease
  • xiapex treatment

Exclusion criteria

Exclusion Criteria:

  • demens/other psychiatric diseases
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
199 participants (actual)
Patient registry
No

Interventions

  • DrugXiapex

    Follow-up of effect of treatment

06

What researchers measure

Primary outcomes

  1. Change in extension deficit from baseline to FU in MCP and PIP joints after treatment

    Time frame: Minimum one year after treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Hartig-Andreasen C, Schroll L, Lange J. Clostridium histolyticum as first-line treatment of Dupuytren's disease. Dan Med J. 2019 Feb;66(2):A5527. PubMed 30722822 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in May 2017, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2017
First posted
Nov 6, 2017
StartActual
Jan 1, 2017
Primary completionActual
May 31, 2017
CompletionActual
Dec 31, 2019
Last update
Apr 22, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03331926
Lead sponsor
Jeppe Lange
Responsible party
Jeppe Lange (Research secretary, Horsens Hospital) — Sponsor-investigator
First posted
Nov 6, 2017
Start date
Jan 1, 2017
Primary completion
May 31, 2017
Completion
Dec 31, 2019
Last update
Apr 22, 2020

Study contacts

Charlotte Hartig-Andreasen, MD, PhD
principal investigator · Regionshospitalet Horsens

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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