Skin Involvement in Dupuytren Surgical Treatment Outcome (Skin in DD)

Skin Involvement in Dupuytren Surgical Treatment Outcome: Interventional Study on Prognostic Value of Cutometry, Ultrasound and Histopathology

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.

Study Overview

• Status: Recruiting
• Conditions: Dupuytren Disease
• Intervention / Treatment: Diagnostic test: Suction cutometry; Diagnostic test: Ultrasound measurement; Procedure: Microbiopsy for histological analysis

Detailed Description

Dupuytren disease (DD) is a common hand disorder, in which a spontaneous fibro-proliferative process (fibrosis) forms strands and nodules in the fascia palmaris of the hand. Normal fibroblasts develop into nodules of myofibroblasts (MF), forming collagen strands which retract skin and cause painless, yet disabling finger contractures. Although numerous conservative treatment options are being explored for these invalidating contractures, surgical removal of DD strands and nodules (through microfasciectomy) remains the standard of care. Retracted skin often makes surgical management challenging and skin-preserving surgery difficult, some patients even requiring full thickness skin grafting (FTG). The disease is very persistent, with reports of recurrent contractures of over 70%. However, in DD patients undergoing FTG less disease recurrence is noticed. This raises a question about pathophysiological skin involvement and its prognostic and therapeutic implications.

The aim of this prospective, interventional study is to further increase insights in the microscopic role of the skin in DD. In earlier research, retracted skin was associated with myofibroblasts (MF) attached to the deepest skin layers. DD recurrence may thus be associated with such retracted skin, possibly due to presence and persistence of aligned MF, fixed to the deepest dermal layers (finding based on own research). Therefore, this study evaluates MF relation to overlying skin and its impact on clinical outcome of microfasciectomy.

In addition, a pilot study has demonstrated that retracted palmar skin in DD loses elasticity, which can be measured by suction cutometry. Based on these findings, the aim is to assess a potential prognostic value of palmar skin involvement in DD and a possible impact on surgery outcome, by simple suction cutometry.

Third, secure measurement of nodule evolution is a clinical challenge. Ultrasound (US) and MRI scanning have been performed. If observed, nodules are often measured by clinical yardstick assessment. However, this technique is unvalidated and unreliable with inevitable significant inter and intra observer unreliability, which improves with sonography. Therefore, simple ultrasound by the treating clinician provides a good tool to collect data. The V Scan is a user-friendly tool to achieve this and with this study the aim is to introduce this non-invasive scan method to provide a prospective investigation of a measurable prognostic value on surgical treatment outcome in DD, focussing on skin involvement by measuring the distance of the nodule/strand to the skin surface.

Integrating all findings of this interventional study will further increase insights in DD pathophysiology, prognostics, and treatment.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilse Degreef, Prof. Dr.; Phone Number: +32 16 33 88 43; Email: ilse.degreef@uzleuven.be
• Study Contact Backup: Name: Anna Tarasiuk; Phone Number: +32 16 33 88 18; Email: orthopedie.research@uzleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • Universitaire Ziekenhuizen KU Leuven
      • Contact: Ilse Degreef, Prof. Dr.; Phone Number: +32 16 33 88 43; Email: ilse.degreef@uzleuven.be
      • Contact: Anna Tarasiuk; Phone Number: +32 16 33 88 18; Email: orthopedie.research@uzleuven.be
      • Principal Investigator: Ilse Degreef, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patients with Dupuytren disease; 50 patients scheduled for microfasciectomy will be enrolled.

Diagnostic test: Suction cutometry; Suction cutometry is a non-invasive evaluation tool which is used to assess skin elasticity objectively and quantitatively.; Diagnostic test: Ultrasound measurement; Ultrasound measurement of distance between skin surface and underlying Dupuytren tissue; Procedure: Microbiopsy for histological analysis; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Passive Extension Deficit (TPED) 12 months post-operative	The Extension capability at 12 months post-microfasciectomy. Extension deficit is measured with a goniometer, shown in degrees (°)	From Baseline to 12 months post-operative
Clinical recurrence	Clinical recurrence under scar at 12 months post-microfasciectomy (answered with yes or no)	At 1 moment during study (12 months post-operation)
Distal Pulpa Palmar Crease Distance (DPPCD) at 3 and 12 months	The measurement (cm) from the tip of a finger to its distal palmar crease, for the index, long, ring and little fingers.	From Baseline to 3 months post-operative and 12 months post-operative
Visual Analogue Scale (VAS) pain	Patients Reported Outcome Measures to quantify the pain of a patient. The VAS pain score runs from 10 to 0, where 10 is "Worst possible pain" and 0 is "No pain".	3 times during study (pre-operative, 3 months and 12 months post-operative)
Visual Analogue Scale (VAS) satisfaction	Patients Reported Outcome Measures to quantify the satisfaction of a patient. The VAS satisfaction score runs from 10 to 0, where 10 is "Very satisfied" and 0 is "unsatisfied".	3 times during study (pre-operative, 3 months and 12 months post-operative)
Brief Michigan Hand Questionnaire	A hand-specific outcomes instrument. It contains 12 items with responses on a 1 through 5 Likert scale regarding several aspects of hand function. The 12 items are totaled and then normalized to yield a summary score on a scale of 0-100. Higher scores indicate better overall functioning and satisfaction.	3 times during study (pre-operative, 3 months and 12 months post-operative)
Rheumatological Unit for Hand Disorders (URAM) scale	A disease-specific questionnaire for Dupuytren contracture, a 9-item scale where each question can be answered with "Without difficulty (0)", "With very little difficulty (1)", "With some difficulty (2)", "With much difficulty (3)", "Almost impossible (4)" or "Impossible (5). The total score lies between 0 and 45.	3 times during study (pre-operative, 3 months and 12 months post-operative)

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Ilse Degreef, Prof. Dr., Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 18, 2025
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Neoplasms; Connective Tissue Diseases; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Contracture; Skin and Connective Tissue Diseases; Dupuytren Contracture
• Other Study ID Numbers: S69302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No