NCT07470684

Brief Summary

Palmar skin is often retracted in Dupuytren disease (DD), making surgical management challenging and skin-preserving surgery difficult. Based on clinical experience in DD surgery and outcome, it is suspected that recurrence may be associated with such retracted skin. Possibly, this is due to presence and persistence of aligned myofibroblasts (MF), fixed to the deepest dermal layers. This interventional study aims to investigate the pathophysiological involvement of palmar skin in Dupuytren disease, and its implications for prognostics and treatment.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Dec 2024Jan 2027

Study Start

First participant enrolled

December 10, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2025

Completed
11 months until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

2.1 years

First QC Date

April 18, 2025

Last Update Submit

July 9, 2026

Conditions

Dupuytren Disease

Outcome Measures

Primary Outcomes (1)

  • Total Passive Extension Deficit (TPED) 3 months post-operative

    The Extension capability at 3 months post-microfasciectomy. Extension deficit is measured with a goniometer, shown in degrees (°)

    From Baseline to 3 months post-operative

Secondary Outcomes (7)

  • Total Passive Extension Deficit (TPED) 12 months post-operative

    From Baseline to 12 months post-operative

  • Clinical recurrence

    At 1 moment during study (12 months post-operation)

  • Distal Pulpa Palmar Crease Distance (DPPCD) at 3 and 12 months

    From Baseline to 3 months post-operative and 12 months post-operative

  • Visual Analogue Scale (VAS) pain

    3 times during study (pre-operative, 3 months and 12 months post-operative)

  • Visual Analogue Scale (VAS) satisfaction

    3 times during study (pre-operative, 3 months and 12 months post-operative)

  • +2 more secondary outcomes

Study Arms (1)

Patients with Dupuytren disease

OTHER

50 patients scheduled for microfasciectomy will be enrolled.

Diagnostic Test: Suction cutometryDiagnostic Test: Ultrasound measurementProcedure: Microbiopsy for histological analysis

Interventions

Suction cutometryDIAGNOSTIC_TEST

Suction cutometry is a non-invasive evaluation tool which is used to assess skin elasticity objectively and quantitatively.

Patients with Dupuytren disease
Ultrasound measurementDIAGNOSTIC_TEST

Ultrasound measurement of distance between skin surface and underlying Dupuytren tissue

Patients with Dupuytren disease
Microbiopsy for histological analysisPROCEDURE

During microfasciectomy, the surgeon will perform a single-5mm microbiopsy of DD nodules with overlying skin in all patients. These biopsies will be preserved in the UZ/KU Leuven Biobank and immunohistochemical analyses will be performed.

Patients with Dupuytren disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
  • Patients ≥ 18 years old, diagnosed with primary Dupuytren disease.
  • Patients must be scheduled for microfasciectomy.

You may not qualify if:

  • Earlier Dupuytren surgery in the hand scheduled for microfasciectomy
  • Patient's unable to give a written participating consent.
  • Younger than 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaire Ziekenhuizen KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsContractureMuscular DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ilse Degreef, Prof. Dr.

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2025

First Posted

March 13, 2026

Study Start

December 10, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)