Dupuytren DiseaseSkin in DDNCT07470684
Skin Involvement in Dupuytren Surgical Treatment Outcome
A study testing Suction cutometry, Ultrasound measurement and Microbiopsy for histological analysis in people with Dupuytren Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren Disease
- What is being tested?
- Suction cutometry, Ultrasound measurement and Microbiopsy for histological analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Dec 2024to 1 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Earlier Dupuytren surgery in the hand scheduled for microfasciectomy
- Patient's unable to give a written participating consent.
- Younger than 18 years of age.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Universitaire Ziekenhuizen KU Leuven
Leuven, Vlaams-Brabant, 3000
About this study
Official title: 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.
Read the 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.
- Conditions
- Dupuytren Disease
- Being tested
- Suction cutometry, Ultrasound measurement, Microbiopsy for histological analysis
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction cutometryDiagnostic test
Suction cutometry is a non-invasive evaluation tool which is used to assess skin elasticity objectively and quantitatively.
Ultrasound measurementDiagnostic test
Ultrasound measurement of distance between skin surface and underlying Dupuytren tissue
Microbiopsy for histological analysisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Dupuytren disease | Other | 50 patients scheduled for microfasciectomy will be enrolled. Receives: Diagnostic Test: Suction cutometry; Diagnostic Test: Ultrasound measurement; Procedure: Microbiopsy for histological analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (°)
Measured: From Baseline to 3 months post-operative
Secondary outcomes (7)
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 (°)
Measured: From Baseline to 12 months post-operative
Clinical recurrence
Clinical recurrence under scar at 12 months post-microfasciectomy (answered with yes or no)
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 3 times during study (pre-operative, 3 months and 12 months post-operative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start10 Dec 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilse Degreef, Prof. Dr., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470684
- Sponsor's protocol ID
- S69302
- Acronym
- Skin in DD
- Status last verified
- Jul 2026
- First submitted
- 18 Apr 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No