NCT07470684

Skin Involvement in Dupuytren Surgical Treatment Outcome

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-10
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: Belgium