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NCT Number: NCT07470684

Skin Involvement in Dupuytren Surgical Treatment Outcome

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.

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Key information

Conditions

Dupuytren Disease Connective Tissue Diseases Contracture Dupuytren Contracture Fibroma Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitaire Ziekenhuizen KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Suction cutometry

Diagnostic Test

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

Ultrasound measurement

Diagnostic Test

Ultrasound measurement of distance between skin surface and underlying Dupuytren tissue

Microbiopsy for histological analysis

Procedure

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.

Primary outcomes

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

    Time frame: From Baseline to 3 months post-operative

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

Secondary outcomes

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

    Time frame: From Baseline to 12 months post-operative

    The Extension capability at 12 months post-microfasciectomy. Extension deficit is measured with a goniometer, shown in degrees (°)

  2. Clinical recurrence

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

    Clinical recurrence under scar at 12 months post-microfasciectomy (answered with yes or no)

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

    Time frame: From Baseline to 3 months post-operative and 12 months post-operative

    The measurement (cm) from the tip of a finger to its distal palmar crease, for the index, long, ring and little fingers.

  4. Visual Analogue Scale (VAS) pain

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

    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".

  5. Visual Analogue Scale (VAS) satisfaction

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

    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".

  6. Brief Michigan Hand Questionnaire

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

    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.

  7. Rheumatological Unit for Hand Disorders (URAM) scale

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

    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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: Skin in DD

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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