Treatment of Dupuytrens contracture in metacarpophalangeal joints by needle treatment vs injection with collagenase enzyme.

Needle fasciotomi vs collagenase for treatment of Dupuytrens contracture in 2nd, 3rd, 4th and 5th metacarpophalangeal joint.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000494-67-DK

Enrollment

Registered

2013-09-09

Start date

2013-10-22

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Dupuytrens contracture MedDRA version: 16.0 Level: LLT Classification code 10065799 Term: Fibrosis deep connective tissue System Organ Class: 100000004859

Interventions

Trade Name: Xiapex Product Name: xiapex Pharmaceutical Form: Concentrate and solvent for suspension for injection INN or Proposed INN: clostridium histo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Dupuytrens disease with one cord in the hand pointing at 2nd, 3rd, 4th or 5th finger. 2) Lag of extension im metacarpophalangeal joint of at least 30 degrees. 3) age > 18 years 4) women and men Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: 1) Former treatment of Dupuytrens disease in the same hand. 2) Other signs of dupuytrens disease than a single cord. 3) lag of extension in proximal- and distal interphalangeal joint in the affected finger. 4) Other dibiliating disease in the affected hand. 5) Allergi or intollerance of collagenase enzyme 6) pregnant women 7) patient that cannot attend follow up 8) anticoagulant medicin other than ASA 150 mg daily 9) treatment with tetracyclin or ciprofloxacin within 2 weeks.

Design outcomes

Primary

Measure	Time frame
Main Objective: to evaluate difference in recurrence rate of dupuytrens contracture following needlefasciotomi or collagenase enzyme injection.; Secondary Objective: to evaluate the primary result after treatment of dupuytrens contracture with needle fascitomi or collagenase enzyme injection. to measure patientevaluated hand function (quick dash) during treatment of dupuytrens contracture with needlefasciotomo or collagenase enzyme injection. ;Primary end point(s): extensionlag in affected finger;Timepoint(s) of evaluation of this end point: after 1 y , 2 y , 3 y and 5 y	—

Measure

Time frame

Main Objective: to evaluate difference in recurrence rate of dupuytrens contracture following needlefasciotomi or collagenase enzyme injection.; Secondary Objective: to evaluate the primary result after treatment of dupuytrens contracture with needle fascitomi or collagenase enzyme injection. to measure patientevaluated hand function (quick dash) during treatment of dupuytrens contracture with needlefasciotomo or collagenase enzyme injection. ;Primary end point(s): extensionlag in affected finger;Timepoint(s) of evaluation of this end point: after 1 y , 2 y , 3 y and 5 y

—

Secondary

Measure	Time frame
Secondary end point(s): Extensionlag after primary treatment. quick-dash score before and after treatment (patientevaluated hand function) ; Timepoint(s) of evaluation of this end point: 1) after initial treatment. 2) before treatment and after 1y , 2y , 3y and 5 y	—

Countries

Denmark

Contacts

Public ContactDepartment Z

Klinik for Håndkirurgi, Gentofte Hospital

claus.hjorth.jensen@regionh.dk4539772436

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026