Dupytren’s disease study A randomized controlled study comparing enzyme treatment (with clostridium histolyticum) with needle transection of Dupytren’s finger contracture.

Dupytren’s disease study A randomized controlled trial comparing clostridium histolyticum with needle aponeurotomy.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001221-13-NO

Enrollment

Registered

2013-07-30

Start date

2013-10-10

Completion date

Unknown

Last updated

2025-02-24

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

Conditions

Dupytren’s disease, primary MCP joint contractures of the third, forth and fifth finger of the hand. MedDRA version: 14.1 Level: LLT Classification code 10009904 Term: Collagen disorder NOS System Organ Class: 100000004859

Interventions

Trade Name: Clostridium Histolyticum (Xiapex) Product Name: Xiapex Pharmaceutical Form: Powder and solvent for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 30 ° or more contracture of one MCP-joint (3. -5. Finger) • Less than 20 ° contracture of adjacent PIP joint • Single hand involvement • Primary contracture (not operated or treated hand earlier for this condition) • Patients 18 years or older. 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 40

Exclusion criteria

Exclusion criteria: • Patients with under 30 ° MCP joint contracture or • 20 ° or more contracture of the adjacent PIP • Ongoing treatment with platelet inhibitors • Prior treatment with tetracycline, 2 weeks earlier to treatment • Patients who are pregnant • Patients with known allergic reaction to local anesthetic or Clostridium Histolyticum • Patients that have been treated for Dupuytren´s earlier on involved hand • Involvement with “need to treat” of both hands

Design outcomes

Primary

Measure	Time frame
Main Objective: A prospective randomized open label trial comparing the treatment results following injections of Clostridium Histolyticum with that of needle aponeurotomy for patients that have not been treated on the involved hand. With focus on the functional results and risks for complications and recurrence of the contracture.;Secondary Objective: Relapse of the symptoms represents a secondary endpoint and is defined by return to least 30 degrees recontracture of the treated MCP joint or more than 20 degrees of the adjacent PIP joint. In addition, we will evaluate hand function and patient satisfaction using quick DASH (Disabilities of the Arm, Shoulder and Hand), brief MHQ (Michigan Hand outcomes Questionnaire), EQ5D, URAM and a VAS (Visual Analogue Scale) pain scale. Strength is measured at follow-up by a Jamar dynamometer;Primary end point(s): Correction of the contracture in degrees constitutes the primary endpoint and will be measured by a manual finger goniometer at follow-up ;Timepoint(s) of evaluation of this end point: 1,4 week and 1,2 and 5 years	—

Measure

Time frame

Main Objective: A prospective randomized open label trial comparing the treatment results following injections of Clostridium Histolyticum with that of needle aponeurotomy for patients that have not been treated on the involved hand. With focus on the functional results and risks for complications and recurrence of the contracture.;Secondary Objective: Relapse of the symptoms represents a secondary endpoint and is defined by return to least 30 degrees recontracture of the treated MCP joint or more than 20 degrees of the adjacent PIP joint. In addition, we will evaluate hand function and patient satisfaction using quick DASH (Disabilities of the Arm, Shoulder and Hand), brief MHQ (Michigan Hand outcomes Questionnaire), EQ5D, URAM and a VAS (Visual Analogue Scale) pain scale. Strength is measured at follow-up by a Jamar dynamometer;Primary end point(s): Correction of the contracture in degrees constitutes the primary endpoint and will be measured by a manual finger goniometer at follow-up ;Timepoint(s) of evaluation of this end point: 1,4 week and 1,2 and 5 years

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Secondary

Measure	Time frame
Secondary end point(s): Relapse of the symptoms represents a secondary endpoint and is defined by return to least 30 degrees recontracture of the treated MCP joint or more than 20 degrees of the adjacent PIP joint. In addition, we will evaluate hand function and patient satisfaction using quick DASH (Disabilities of the Arm, Shoulder and Hand), brief MHQ (Michigan Hand outcomes Questionnaire), EQ5D, URAM and a VAS (Visual Analogue Scale) pain scale. Strength is measured at follow-up by a Jamar dynamometer ;Timepoint(s) of evaluation of this end point: 1,4 week and 1,2 and 5 years	—

Measure

Time frame

Secondary end point(s): Relapse of the symptoms represents a secondary endpoint and is defined by return to least 30 degrees recontracture of the treated MCP joint or more than 20 degrees of the adjacent PIP joint. In addition, we will evaluate hand function and patient satisfaction using quick DASH (Disabilities of the Arm, Shoulder and Hand), brief MHQ (Michigan Hand outcomes Questionnaire), EQ5D, URAM and a VAS (Visual Analogue Scale) pain scale. Strength is measured at follow-up by a Jamar dynamometer ;Timepoint(s) of evaluation of this end point: 1,4 week and 1,2 and 5 years

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Countries

Norway

Contacts

Public ContactOrtopedisk avdeling

Akershus universitetssykehus

postmottak@ahus.no4702900

Outcome results

None listed

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