Dupuytren's DiseaseMicronervesNCT06142929
Micronerves in Dupuytren and the Impact of Its Dissection on Recurrence
An observational study of Dupuytren's Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren's Disease
- What is being tested?
- Microfasciectomy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2024to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
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.
Who may be able to join
- Participants eligible for inclusion in this study must meet all of the following criteria:
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universitaire Ziekenhuizen KU Leuven
Leuven, Vlaams-Brabant, 3000
Ilse Degreef, Prof. Dr., +32 16 33 88 43, ilse.degreef@uzleuven.be
Anna Tarasiuk, +32 16 33 88 18, orthopedie.research@uzleuven.be
About this study
Official title: Observational Study on Small Nerve Bundles in Dupuytren Disease and the Impact of Its Dissection on Recurrence.
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.
Read the detailed description
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 restricitions. Finger movement can be restored by surgery (removing the fibrosis tissue), but recurrence is a major problem (reports of >70%) and this is difficult to treat.
Through microfasciectomy, the presence of small nerve bundles (micronerves) were observed in the finger (other than the digital nerves) through microsurgical enlargement. These nerves are possibly related to the hand fascia, which is the origin of DD. Palmaris fascia innervation was recently elucidated in 16 cadavers and recent research had demonstrated that the palmar aponeurosis is densely innervated and contains a variety of sensory corpuscles as wall as free nerve endings.
These micronerves and their dissection could play a role in the recurrence of DD. This thought is substantiated by the fact neuromas (formed by transection of nerves) were found in recurrence DD and nerve damage is generally known to cause fibrosis (as seen in chronic reactive pain syndrome). This study will investigate the role of these micronerves in DD, the impact of its dissection on formation of neuromas and on recurrence.
It's an observational study, investigation 2 groups of patients. Group 1 being patients with primary DD and group 2 patients with recurrence DD. The nerves and possible neuromas will be documented (presence, location, numbers and (unavoidable) micronerve transections) on a standard map and by digital photomicrography in both groups. The first aim is to confirm their presence and their proximity to the DD fibrosis tissue. Secondly, these allocations will be statistically correlated with clinical outcome and compared between the 2 groups. The ultimate goal of these mappings is to develop new surgical techniques that avoid cutting there nerves and/or cut them at preferable locations (away from recurrence, most likely more proximal at a distance to the proximal interphalangeal joints). Hereby an improved surgical technique (microfasciectomy) can possible reduce/avoid neuroma formation, pain and possibly recurrence.
Also, the presence of nerve growth factor (NGF) will be evaluated. The purpose is to provide information on potential neuro-induced fibrosis. NGF is a cell signalling cytokine that was demonstrated earlier to be associated with nerve tissue, neuromas and pain level. It is linked to the alpha-smooth actin expressing myofibroblast, 'activated' connective tissue cells with contractile properties producing collagen strands that cause the finger contractures. Therefore, the presence of NGF and myofibroblast cells crowd around NGF foci will be studied in a biopsy taken per-operatively. Focus will be on the direct environment of the neuromas. The presence of NGF will also be quantified and compared between both groups. It there is a higher amount of NGF in recurrence, there is a possible role for neuro-induced fibrosis and this creates opportunities to select this protein as a target of treatment to improve clinical outcome.
- Conditions
- Dupuytren's Disease
- Being tested
- Microfasciectomy
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrofasciectomyProcedure or surgery
Using the microscope in Dupuytren's surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Microfasciectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of neuromas, NGF, αSMA and S100
Presence of neuromas, NGF, αSMA and S100 in Dupuytren nodules after resection.
Measured: During surgery/microfasciectomy
Secondary outcomes (2)
Presence of micronerves
The presence of micronerves with micro-anatomical description in the digital palmar fascia and their relation to the Dupuytren tissue.
Measured: During surgery/microfasciectomy
Correlate clinical outcome (motion, pain, recurrence) with these findings (micronerve dissection, presence of neuromas, NGF and αSMA) in both groups
- Objective clinical outcome:
- Range of motion (by goniometry of Distal interphalangeal, Proximal Interphalangeal and metacarpophalangeal joints)
- Abe. diathesis scoring
- Patient reported outcome:
- QUICK Dash for functionality
- Visual Analogue Scale (VAS) questionnaire on satisfaction
- Visual Analogue Scale (VAS) questionnaire on pain
Measured: pre-operative, post-operative (10 days, 3 months, 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Jan 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren's 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 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
- NCT06142929
- Sponsor's protocol ID
- S68137
- Acronym
- Micronerves
- Status last verified
- Mar 2026
- First submitted
- 15 Nov 2023
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Small Nerve Bundles in Dupuytren Disease and the Impact of Its Dissection on Recurrence.
- ClinicalTrials.gov ID
- NCT06142929
- Acronym / sponsor ID
- Micronerves / S68137
- Conditions
- Dupuytren's Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 restricitions. Finger movement can be restored by surgery (removing the fibrosis tissue), but recurrence is a major problem (reports of >70%) and this is difficult to treat.
Through microfasciectomy, the presence of small nerve bundles (micronerves) were observed in the finger (other than the digital nerves) through microsurgical enlargement. These nerves are possibly related to the hand fascia, which is the origin of DD. Palmaris fascia innervation was recently elucidated in 16 cadavers and recent research had demonstrated that the palmar aponeurosis is densely innervated and contains a variety of sensory corpuscles as wall as free nerve endings.
These micronerves and their dissection could play a role in the recurrence of DD. This thought is substantiated by the fact neuromas (formed by transection of nerves) were found in recurrence DD and nerve damage is generally known to cause fibrosis (as seen in chronic reactive pain syndrome). This study will investigate the role of these micronerves in DD, the impact of its dissection on formation of neuromas and on recurrence.
It's an observational study, investigation 2 groups of patients. Group 1 being patients with primary DD and group 2 patients with recurrence DD. The nerves and possible neuromas will be documented (presence, location, numbers and (unavoidable) micronerve transections) on a standard map and by digital photomicrography in both groups. The first aim is to confirm their presence and their proximity to the DD fibrosis tissue. Secondly, these allocations will be statistically correlated with clinical outcome and compared between the 2 groups. The ultimate goal of these mappings is to develop new surgical techniques that avoid cutting there nerves and/or cut them at preferable locations (away from recurrence, most likely more proximal at a distance to the proximal interphalangeal joints). Hereby an improved surgical technique (microfasciectomy) can possible reduce/avoid neuroma formation, pain and possibly recurrence.
Also, the presence of nerve growth factor (NGF) will be evaluated. The purpose is to provide information on potential neuro-induced fibrosis. NGF is a cell signalling cytokine that was demonstrated earlier to be associated with nerve tissue, neuromas and pain level. It is linked to the alpha-smooth actin expressing myofibroblast, 'activated' connective tissue cells with contractile properties producing collagen strands that cause the finger contractures. Therefore, the presence of NGF and myofibroblast cells crowd around NGF foci will be studied in a biopsy taken per-operatively. Focus will be on the direct environment of the neuromas. The presence of NGF will also be quantified and compared between both groups. It there is a higher amount of NGF in recurrence, there is a possible role for neuro-induced fibrosis and this creates opportunities to select this protein as a target of treatment to improve clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Dupuytren disease | – | Procedure: Microfasciectomy50 patients with primary Dupuytren disease that are selected for surgery and will undergo the resection of Dupuytren tissue with the microfasciectomy technique |
| Recurrence Dupuytren disease | – | Procedure: Microfasciectomy30 patients with recurrence Dupuytren disease that are selected for surgery and will undergo the resection of Dupuytren tissue with the microfasciectomy technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Participants eligible for inclusion in this study must meet all of the following criteria:
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrofasciectomyUsing the microscope in Dupuytren's surgery | Procedure or surgery | Primary Dupuytren disease, Recurrence Dupuytren disease |
Primary outcome
Presence of neuromas, NGF, αSMA and S100
Time frame: During surgery/microfasciectomy
Presence of neuromas, NGF, αSMA and S100 in Dupuytren nodules after resection.
2 secondary outcomes
Presence of micronerves
Time frame: During surgery/microfasciectomy
Correlate clinical outcome (motion, pain, recurrence) with these findings (micronerve dissection, presence of neuromas, NGF and αSMA) in both groups
Time frame: pre-operative, post-operative (10 days, 3 months, 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilse Degreef, Prof. Dr. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dupuytren's Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilse Degreef, Prof. Dr. (+32 16 33 88 43, ilse.degreef@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of neuromas, NGF, αSMA and S100 (time frame: During surgery/microfasciectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.