Dupuytren's DiseasePhase 2EchoNCT06321991
Nodular Shrinking in Dupuytren Disease
A Phase 2 study testing Ultrasound measurement in people with Dupuytren's Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Dupuytren disease (DD) is a common hand disorder with disabling finger contractures that may require surgery to restore function. In the early stages of the disease, the nodules (Tubiana stage 0) are usually painless, but a reason for concern to many patients. 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?
- Ultrasound measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Feb 2024to 1 Mar 2027
- Phase
- Phase 2
- 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
Who may be able to join
- 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 Dupuytren disease.
- Included patients have a stage 0 DD (nodule of at least 5 mm in the involved hand without contracture).
- The participant has well distinguished noduli that are clearly visible on US (ultrasound)
Who cannot join
- 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.
- Patients with prior Dupuytren surgery in the involved hand.
- Patients with a higher Tubiana grading than nodular stage 0.
- Open wound in the palm of the treated hand.
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
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Ilse Degreef, Prof. Dr., +3216338843, ilse.degreef@uzleuven.be
Anna Tarasiuk, +3216338818, orthopedie.research@uzleuven.be
About this study
Official title: Nodular Shrinking in Stage 0 Dupuytren Disease: an Evidence-based Approach for Early Stage Treatment to Prevent Progression to Advanced Finger Contractures
Dupuytren disease (DD) is a common hand disorder with disabling finger contractures that may require surgery to restore function. In the early stages of the disease, the nodules (Tubiana stage 0) are usually painless, but a reason for concern to many patients. Not rarely, lifestyle measures and even risky treatment options as radiotherapy are advised, yet no therapy to prevent disease evolution has a solid proven effect. Furthermore, reliable non-invasive measurement of early stage DD is not validated.
Evidence was found that pharmacotherapy may influence DD evolution, but valuable clinical trials are limited. Case series and non-published explorative follow-up suggested local treatment with antioxidant vitamin E to possibly interfere with an evolution of DD nodules to contracting strands. This study aims to provide evidence on efficiency of this non-invasive treatment option.
Secure measurement of nodule evolution is a clinical challenge. To measure this evolution, ultrasound and MRI scanning are currently being performed. Stage 0 (nodules) is more challenging to quantify. A strict individual follow-up by the treating clinician is needed to standardize measurement of selected (treated) nodules. Therefore, simple ultrasound by the treating clinician may provide an good tool to collect data. This study aims to introduce and validate this non-invasive scan method and provide a prospective double blind investigation of a measurable effect of non-invasive preventive treatment for stage 0 DD to improve clinical outcome.
Read the detailed description
Dupuytren disease (DD) is a common hand disorder with disabling finger contractures that may require surgery to restore function. The contractures are caused by progressive fibroproliferative tissue forming nodules and strands in the palmar fascia that eventually cause loss of finger extension. In the early stages of the disease, the nodules (Tubiana stage 0) are usually painless, but a reason for concern to many patients. They often seek the hand surgeon's advice and worry about losing hand function the coming years, commonly requesting for precautionary measures to stop evolution towards contractures (Tubiana stage 1-4). Not rarely, lifestyle measures and even risky treatment options as radiotherapy are advised, yet no therapy to prevent disease evolution has a solid proven effect. Furthermore, reliable non-invasive measurement of early stage DD is not validated.
However, this is needed to explore any efficient preventive treatment that may be cost-efficient for patients and healthcare.
Evidence was found that pharmacotherapy may influence DD evolution, but valuable clinical trials are limited. Case series and non-published explorative follow-up suggested local treatment with antioxidant vitamin E to possibly interfere with an evolution of DD nodules to contracting strands. Therefore, it is recommended to consider local creams to the palms in such situation.
This study aims to provide evidence on efficiency of this non-invasive treatment option. Secure measurement of nodule evolution is a clinical challenge. To measure this evolution, ultrasound and MRI scanning are currently being performed. In clinical practice, although clinical staging of contractures is reliable, stage 0 (nodules) is more challenging to quantify. If observed, nodules (evolution) are often measured by clinical yardstick assessment. However, this technique is unvalidated and unreliable with inevitable significant inter- and intra-observer unreliability, which may improve with sonography. A strict individual follow-up by the treating clinician is needed to standardize measurement of selected (treated) nodules. Therefore, simple ultrasound by the treating clinician may provide an good tool to collect data. The V-Scan (simple office-based Bluetooth ultrasonography) may aid to achieve this and its use is successfully implemented since 1 year at the hand Surgery department at Université Catholique de Louvain (UCL) by and under supervision of Prof Dr X. Libouton.
This study aims to introduce and validate this non-invasive scan method and provide a prospective double blind investigation of a measurable effect of non-invasive preventive treatment for stage 0 DD to improve clinical outcome.
Rationale: Application of antioxidant creme cause V-scan measurable arrest or even shrinking of the nodules in stage 0 of DD.
- Conditions
- Dupuytren's Disease
- Being tested
- Vitamin E-creme (Remederm®) vs Vaseline (Placebo), Ultrasound measurement
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin E-creme (Remederm®) vs Vaseline (Placebo)Drug
Louis Widmer Remederm® Face Cream Without Perfume 50 ml is a skin care product that contains vitamin E as an active ingredient. Before applying Remederm®, the following are advised: On dry clean skin thoroughly before applying Remederm®, apply a layer of cream cutaneous to the hand palm, twice a day: morning and evening, massage cream into skin until absorbed. This procedure is applied by the patient treated with Vaseline or Remederm®.
Ultrasound measurementProcedure or surgery
Nodule evolution will be measured with ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Dupuytren Disease patients receiving Vasiline (Placebo) | Placebo comparator | 40 patients with Dupuytren Disease (primary DD nodules: stage 0, no contracture in the involved hand) will be randomized into the group where they will receive Vasiline Receives: Drug: Vitamin E-creme (Remederm®) vs Vaseline (Placebo); Procedure: Ultrasound measurement |
| Dupuytren Disease patients receiving Remederm® (Vitamine E creme) | Active comparator | 40 patients with Dupuytren Disease (primary DD nodules: stage 0, no contracture in the involved hand) will be randomized into the group where they will receive Remederm® (Vitamine E creme) Receives: Drug: Vitamin E-creme (Remederm®) vs Vaseline (Placebo); Procedure: Ultrasound measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Downsizing of the largest nodule diameter
A significant downsize (>1mm because V-scan (ultrasonography) is accurate to 1mm) of the largest nodule diameter in the palm of the hand.
Measured: 1 year
Secondary outcomes (6)
VAS questionnaire on pain
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The patient is asked to rate their current level of pain by placing a mark on the line.
Measured: 1 year
VAS questionnaire on satisfaction
The Visual Analogue Scale (VAS) measures satisfaction. The VAS consists of a 10cm line, with two end points representing 0 ('complete dissatisfaction') and 10 ('full satisfaction'). The patient is asked to rate their current level of satisfaction by placing a mark on the line.
Measured: 1 year
QUICK Dash for functionality
This questionnaire asks the patient about the symptoms as well as the ability to perform certain activities. It consists of 11 items ranging from 1 ('not at all/no difficulty') to 5 ('extremely/unable').
Measured: 1 year
Abe Diathesis scoring
An objective method to evaluate the risk of recurrence and extension of Dupuytren's disease. This scoring counts 1 point for each for bilateral, small finger surgery and if onset < 50 y. The scoring counts 2 points each for Ledderhose, knuckle pads, thumb / index disease. Diathesis score = sum of points. Increased risk for score > 4.
Measured: Baseline
Range of motion
By using goniometry of Distal interphalangeal, Proximal Interphalangeal and metacarpophalangeal joints
Measured: 1 year
Recurrence rate
Recurrence is defined as the clinical re-appearance of the treated nodules or a significant increase of diameter (>1mm) or evolution to a higher stage (Tubiana stage 1-4) of the disease than 0 at intake.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start15 Feb 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Simple random allocation will be ensured by the principal investigators' designated staff (study nurse of IORT), who will not be involved in recruiting trial participants, medical care, drug administration or follow-up, through the generation of a random numbers table with computer software program. A randomization list will be prepared by the Sponsor's designated staff, not involved in recruiting Trial participants, medical care, drug administration or follow-up.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- 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
- NCT06321991
- Sponsor's protocol ID
- S68382
- Acronym
- Echo
- Status last verified
- May 2026
- First submitted
- 13 Mar 2024
- Last updated
- 11 May 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nodular Shrinking in Stage 0 Dupuytren Disease: an Evidence-based Approach for Early Stage Treatment to Prevent Progression to Advanced Finger Contractures
- ClinicalTrials.gov ID
- NCT06321991
- Acronym / sponsor ID
- Echo / S68382
- Conditions
- Dupuytren's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 20 Mar 2024 (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 common hand disorder with disabling finger contractures that may require surgery to restore function. In the early stages of the disease, the nodules (Tubiana stage 0) are usually painless, but a reason for concern to many patients. Not rarely, lifestyle measures and even risky treatment options as radiotherapy are advised, yet no therapy to prevent disease evolution has a solid proven effect. Furthermore, reliable non-invasive measurement of early stage DD is not validated.
Evidence was found that pharmacotherapy may influence DD evolution, but valuable clinical trials are limited. Case series and non-published explorative follow-up suggested local treatment with antioxidant vitamin E to possibly interfere with an evolution of DD nodules to contracting strands. This study aims to provide evidence on efficiency of this non-invasive treatment option.
Secure measurement of nodule evolution is a clinical challenge. To measure this evolution, ultrasound and MRI scanning are currently being performed. Stage 0 (nodules) is more challenging to quantify. A strict individual follow-up by the treating clinician is needed to standardize measurement of selected (treated) nodules. Therefore, simple ultrasound by the treating clinician may provide an good tool to collect data. This study aims to introduce and validate this non-invasive scan method and provide a prospective double blind investigation of a measurable effect of non-invasive preventive treatment for stage 0 DD to improve clinical outcome.
Detailed description
Dupuytren disease (DD) is a common hand disorder with disabling finger contractures that may require surgery to restore function. The contractures are caused by progressive fibroproliferative tissue forming nodules and strands in the palmar fascia that eventually cause loss of finger extension. In the early stages of the disease, the nodules (Tubiana stage 0) are usually painless, but a reason for concern to many patients. They often seek the hand surgeon's advice and worry about losing hand function the coming years, commonly requesting for precautionary measures to stop evolution towards contractures (Tubiana stage 1-4). Not rarely, lifestyle measures and even risky treatment options as radiotherapy are advised, yet no therapy to prevent disease evolution has a solid proven effect. Furthermore, reliable non-invasive measurement of early stage DD is not validated.
However, this is needed to explore any efficient preventive treatment that may be cost-efficient for patients and healthcare.
Evidence was found that pharmacotherapy may influence DD evolution, but valuable clinical trials are limited. Case series and non-published explorative follow-up suggested local treatment with antioxidant vitamin E to possibly interfere with an evolution of DD nodules to contracting strands. Therefore, it is recommended to consider local creams to the palms in such situation.
This study aims to provide evidence on efficiency of this non-invasive treatment option. Secure measurement of nodule evolution is a clinical challenge. To measure this evolution, ultrasound and MRI scanning are currently being performed. In clinical practice, although clinical staging of contractures is reliable, stage 0 (nodules) is more challenging to quantify. If observed, nodules (evolution) are often measured by clinical yardstick assessment. However, this technique is unvalidated and unreliable with inevitable significant inter- and intra-observer unreliability, which may improve with sonography. A strict individual follow-up by the treating clinician is needed to standardize measurement of selected (treated) nodules. Therefore, simple ultrasound by the treating clinician may provide an good tool to collect data. The V-Scan (simple office-based Bluetooth ultrasonography) may aid to achieve this and its use is successfully implemented since 1 year at the hand Surgery department at Université Catholique de Louvain (UCL) by and under supervision of Prof Dr X. Libouton.
This study aims to introduce and validate this non-invasive scan method and provide a prospective double blind investigation of a measurable effect of non-invasive preventive treatment for stage 0 DD to improve clinical outcome.
Rationale: Application of antioxidant creme cause V-scan measurable arrest or even shrinking of the nodules in stage 0 of DD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Simple random allocation will be ensured by the principal investigators' designated staff (study nurse of IORT), who will not be involved in recruiting trial participants, medical care, drug administration or follow-up, through the generation of a random numbers table with computer software program. A randomization list will be prepared by the Sponsor's designated staff, not involved in recruiting Trial participants, medical care, drug administration or follow-up.
| Arm | Type | Receives |
|---|---|---|
| Dupuytren Disease patients receiving Vasiline (Placebo) | Placebo comparator | Drug: Vitamin E-creme (Remederm®) vs Vaseline (Placebo), Procedure: Ultrasound measurement40 patients with Dupuytren Disease (primary DD nodules: stage 0, no contracture in the involved hand) will be randomized into the group where they will receive Vasiline |
| Dupuytren Disease patients receiving Remederm® (Vitamine E creme) | Active comparator | Drug: Vitamin E-creme (Remederm®) vs Vaseline (Placebo), Procedure: Ultrasound measurement40 patients with Dupuytren Disease (primary DD nodules: stage 0, no contracture in the involved hand) will be randomized into the group where they will receive Remederm® (Vitamine E creme) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 Dupuytren disease.
- Included patients have a stage 0 DD (nodule of at least 5 mm in the involved hand without contracture).
- The participant has well distinguished noduli that are clearly visible on US (ultrasound)
Key exclusion criteria (6 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.
- Patients with prior Dupuytren surgery in the involved hand.
- Patients with a higher Tubiana grading than nodular stage 0.
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 |
|---|---|---|
| Vitamin E-creme (Remederm®) vs Vaseline (Placebo)Louis Widmer Remederm® Face Cream Without Perfume 50 ml is a skin care product that contains vitamin E as an active ingredient. Before applying Remederm®, the following are advised: On dry clean skin thoroughly before applying Remederm®, apply a layer of cream cutaneous to the hand palm, twice a day: morning and evening, massage cream into skin until absorbed. This procedure is applied by the patient treated with Vaseline or Remederm®. | Drug | Dupuytren Disease patients receiving Remederm® (Vitamine E creme), Dupuytren Disease patients receiving Vasiline (Placebo) |
| Ultrasound measurementNodule evolution will be measured with ultrasound. | Procedure or surgery | Dupuytren Disease patients receiving Remederm® (Vitamine E creme), Dupuytren Disease patients receiving Vasiline (Placebo) |
Primary outcome
Downsizing of the largest nodule diameter
Time frame: 1 year
A significant downsize (>1mm because V-scan (ultrasonography) is accurate to 1mm) of the largest nodule diameter in the palm of the hand.
6 secondary outcomes
VAS questionnaire on pain
Time frame: 1 year
VAS questionnaire on satisfaction
Time frame: 1 year
QUICK Dash for functionality
Time frame: 1 year
Abe Diathesis scoring
Time frame: Baseline
Range of motion
Time frame: 1 year
Recurrence rate
Time frame: 1 year
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 11 May 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?
A Phase 2 study testing Ultrasound measurement in people with 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 6 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 11 May 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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. (+3216338843, ilse.degreef@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Downsizing of the largest nodule diameter (time frame: 1 year). 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 11 May 2026.