Micronerves in Dupuytren and the Impact of Its Dissection on Recurrence

NCT06142929 | Recruiting

• 1 other identifier: S68137
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Dupuytren disease (DD) is a highly prevalent disabling hand disease. Spontaneous fibrosis nodules and strands in the palms of the hand cause finger contractures in disturbing positions and movement restrictions. Finger movement can be restored by surgery (removing the fibrosis tissue), but recurrence is a major problem and this is difficult to treat. Through microfasciectomy, the presence of small nerve bundles (micronerves) were observed. These nerves are possibly related to the hand fascia, which is the origin of Dupuytren disease. These micornerves and their dissection could play a role in the recurrence of DD. This study will investigate the role of these micronerves in DD, the impact of its dissection on formation of neuromas and on recurrence. Also, the presence of nerve growth factor (NGF) will be evaluated. The purpose is to provide information on potential neuro-induced fibrosis.

Conditions

Dupuytren's Disease

Outcome Measures

Primary Outcomes (1)

• Presence of neuromas, NGF, αSMA and S100

  Presence of neuromas, NGF, αSMA and S100 in Dupuytren nodules after resection.

  During surgery/microfasciectomy

Secondary Outcomes (2)

• Presence of micronerves

  During surgery/microfasciectomy

• Correlate clinical outcome (motion, pain, recurrence) with these findings (micronerve dissection, presence of neuromas, NGF and αSMA) in both groups

  pre-operative, post-operative (10 days, 3 months, 12 months)

Study Arms (2)

Primary Dupuytren disease

50 patients with primary Dupuytren disease that are selected for surgery and will undergo the resection of Dupuytren tissue with the microfasciectomy technique

Procedure: Microfasciectomy

Recurrence Dupuytren disease

30 patients with recurrence Dupuytren disease that are selected for surgery and will undergo the resection of Dupuytren tissue with the microfasciectomy technique

Procedure: Microfasciectomy

Interventions

Microfasciectomy PROCEDURE

Using the microscope in Dupuytren's surgery

Primary Dupuytren disease; Recurrence Dupuytren disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 18 years old that present with Dupuytren disease (primary or recurrence) and that are selected for surgery and will undergo the resection of Dupuytren tissue with the microfasciectomy technique.

You may qualify if:

• The participant or his/her legally authorized representative voluntary signed the informed consent prior to the first assessment
• Participants are ≥ 18 years and diagnosed with primary/recurrent Dupuytren disease
• Included patients are eligible for microfasciectomy

You may not qualify if:

• Participants eligible for this study must not meet any of the following criteria:
• Patients \< 18 years
• Patient included in an interventional trial with an investigational medicinal product
• Patients with cognitive impairments, severe rheumatic disease and neurological disorders leading to flexion deformities of the fingers

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

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

Study Officials

• Ilse Degreef, Prof. Dr.

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilse Degreef, Prof. Dr.

CONTACT

+32 16 33 88 43; ilse.degreef@uzleuven.be

Anna Tarasiuk

CONTACT

+32 16 33 88 18; orthopedie.research@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 22, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)