Dupuytren's DiseasePRODUCTNCT07353060
Prognostic Profile of Dupuytren's Disease: a Cohort Study (PRODUCT)
A study testing Questionnaires and Clinical examination in people with Dupuytren's Disease, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Dupuytren's disease is characterized by retractile fibrosis of the superficial palmar aponeurosis, which can lead to irreversible flexion contractures of the fingers and lasting functional impairment. Widespread throughout the world, it has a particularly high prevalence in northern European countries. 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?
- Questionnaires and Clinical examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2026to 4 Feb 2031
- Phase
- Interventional
- 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
- Patient, male or female, over 18 years of age
- Patient with Dupuytren's disease confirmed by clinical examination: nodule or cord arising from the superficial palmar aponeurosis, visible or palpable
- Aponeurotic cord causing an MCP or PIP joint flexion contracture of at least 20°
- Indication for percutaneous needle ablation (flexion contracture of at least 20°, functionally impaired according to the patient)
- Acceptance of percutaneous needle ablation by the patient
- Patient affiliated with or covered by a social security scheme
- Patient having been informed and having signed a free and informed written consent
- Negative urine pregnancy test for women of childbearing age
Who cannot join
- Minor patient,
- Patient with another condition, infection, or wound of the hand,
- Patient participating in another clinical trial,
- Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision,
- Person unable to express their consent,
- Pregnant, breastfeeding, or parturient woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Lariboisière
Paris, 75010
Johann Beaudreuil, Pr, johann.beaudreuil@aphp.fr
About this study
Official title: Prognostic Profile of Dupuytren's Disease: a Cohort Study
Dupuytren's disease is characterized by retractile fibrosis of the superficial palmar aponeurosis, which can lead to irreversible flexion contractures of the fingers and lasting functional impairment. Widespread throughout the world, it has a particularly high prevalence in northern European countries. This has been estimated at between 3.5% and 11% in England and Denmark. This prevalence is expected to increase over time due to the aging population. Risk factors for the disease include age, male sex, heredity, diabetes, smoking, and alcohol consumption. The resulting disability is not spontaneously reversible. It affects various aspects of daily life, most notably personal care, nutrition, and social interaction.
Treatment for Dupuytren's disease, whether medical or surgical, remains symptomatic to date and does not preclude the possibility of recurrence. In France, it is based on percutaneous needle aponeurotomy and surgical aponeurectomy. Its objectives are to reduce the flexion contracture of the fingers and the functional disability caused by the disease. Enzymatic aponeurosis with collagenase is also possible, but it is less well tolerated than percutaneous needle aponeurotomy. It is more expensive and not covered by health insurance.
The widespread adoption of a medical-surgical strategy that positions percutaneous needle aponeurotomy as the first-line treatment could improve the acceptability of Dupuytren's disease treatment and significantly reduce its cost to healthcare systems. However, the impact of this strategy depends on the extent to which second-line surgery is required. This use has been little studied. The proportion of patients requiring surgical treatment after percutaneous needle aponeurotomy is estimated to be 10 to 18%. These data are based on small sample sizes observed over varying follow-up periods. They need to be verified in large populations using a prospective study. Moreover, the factors associated with the need for surgery after percutaneous needle ablation for Dupuytren's disease are currently poorly understood. Understanding these factors would be beneficial for optimizing medical and surgical management. It could allow for better tailoring of treatment options to the patient's individual profile.
Read the detailed description
Percutaneous needle aponeurotomy for Dupuytren's disease was developed by Jean-Luc Lermusiaux in 1972, in the Rheumatology Department of Lariboisière Hospital in Paris. Its efficacy, tolerability, simplicity, and low cost make it a standard treatment. For many, provided they are informed about the existence of this technique and master it, it is the first-line treatment for Dupuytren's disease. Within the framework of a graduated medical-surgical strategy, and in our practice, surgery for Dupuytren's disease therefore appears as a second-line treatment indicated in cases of failure after percutaneous treatment. This positioning is, however, not universally accepted. Surgery remains the most common treatment for Dupuytren's disease today.
The main objective of the study is to describe the proportion of patients requiring surgery within 3 years of treatment by percutaneous needle aponeurotomy for Dupuytren's disease
- Conditions
- Dupuytren's Disease
- Being tested
- Questionnaires, Clinical examination
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
The functional assessment of patients will be carried out using the Quick DASH, URAM and Southampton scores.
Clinical examinationOther
A clinical examination of the patient with assessment of the morphological impact by quantifying the deformity of the fingers in flexion using angular measurement and the Tubiana score
| Study group | Role | What they receive |
|---|---|---|
| Patient with Dupuytren's disease | Experimental | Treatment by percutaneous needle aponeurotomy Receives: Other: Questionnaires; Other: Clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of surgery (yes/no)
Use of surgery within 3 years following treatment by percutaneous needle aponeurotomy for Dupuytren's disease. the result is yes or not.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start4 Feb 2026 (estimated)
- Primary completion4 Dec 2030 (estimated)
- Study completion4 Feb 2031 (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 GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 305 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353060
- Sponsor's protocol ID
- 2024-A00473-44
- Acronym
- PRODUCT
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Profile of Dupuytren's Disease: a Cohort Study
- ClinicalTrials.gov ID
- NCT07353060
- Acronym / sponsor ID
- PRODUCT / 2024-A00473-44
- Conditions
- Dupuytren's Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 305 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 4 Feb 2026 (estimated)
- Primary completion
- 4 Dec 2030 (estimated)
- Study completion
- 4 Feb 2031 (estimated)
- First posted
- 20 Jan 2026 (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's disease is characterized by retractile fibrosis of the superficial palmar aponeurosis, which can lead to irreversible flexion contractures of the fingers and lasting functional impairment. Widespread throughout the world, it has a particularly high prevalence in northern European countries. This has been estimated at between 3.5% and 11% in England and Denmark. This prevalence is expected to increase over time due to the aging population. Risk factors for the disease include age, male sex, heredity, diabetes, smoking, and alcohol consumption. The resulting disability is not spontaneously reversible. It affects various aspects of daily life, most notably personal care, nutrition, and social interaction.
Treatment for Dupuytren's disease, whether medical or surgical, remains symptomatic to date and does not preclude the possibility of recurrence. In France, it is based on percutaneous needle aponeurotomy and surgical aponeurectomy. Its objectives are to reduce the flexion contracture of the fingers and the functional disability caused by the disease. Enzymatic aponeurosis with collagenase is also possible, but it is less well tolerated than percutaneous needle aponeurotomy. It is more expensive and not covered by health insurance.
The widespread adoption of a medical-surgical strategy that positions percutaneous needle aponeurotomy as the first-line treatment could improve the acceptability of Dupuytren's disease treatment and significantly reduce its cost to healthcare systems. However, the impact of this strategy depends on the extent to which second-line surgery is required. This use has been little studied. The proportion of patients requiring surgical treatment after percutaneous needle aponeurotomy is estimated to be 10 to 18%. These data are based on small sample sizes observed over varying follow-up periods. They need to be verified in large populations using a prospective study. Moreover, the factors associated with the need for surgery after percutaneous needle ablation for Dupuytren's disease are currently poorly understood. Understanding these factors would be beneficial for optimizing medical and surgical management. It could allow for better tailoring of treatment options to the patient's individual profile.
Detailed description
Percutaneous needle aponeurotomy for Dupuytren's disease was developed by Jean-Luc Lermusiaux in 1972, in the Rheumatology Department of Lariboisière Hospital in Paris. Its efficacy, tolerability, simplicity, and low cost make it a standard treatment. For many, provided they are informed about the existence of this technique and master it, it is the first-line treatment for Dupuytren's disease. Within the framework of a graduated medical-surgical strategy, and in our practice, surgery for Dupuytren's disease therefore appears as a second-line treatment indicated in cases of failure after percutaneous treatment. This positioning is, however, not universally accepted. Surgery remains the most common treatment for Dupuytren's disease today.
The main objective of the study is to describe the proportion of patients requiring surgery within 3 years of treatment by percutaneous needle aponeurotomy for Dupuytren's disease
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Dupuytren's disease | Experimental | Other: Questionnaires, Other: Clinical examinationTreatment by percutaneous needle aponeurotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient, male or female, over 18 years of age
- Patient with Dupuytren's disease confirmed by clinical examination: nodule or cord arising from the superficial palmar aponeurosis, visible or palpable
- Aponeurotic cord causing an MCP or PIP joint flexion contracture of at least 20°
- Indication for percutaneous needle ablation (flexion contracture of at least 20°, functionally impaired according to the patient)
- Acceptance of percutaneous needle ablation by the patient
Key exclusion criteria (6 listed)
- Minor patient,
- Patient with another condition, infection, or wound of the hand,
- Patient participating in another clinical trial,
- Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision,
- Person unable to express their consent,
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 |
|---|---|---|
| QuestionnairesThe functional assessment of patients will be carried out using the Quick DASH, URAM and Southampton scores. | Other | Patient with Dupuytren's disease |
| Clinical examinationA clinical examination of the patient with assessment of the morphological impact by quantifying the deformity of the fingers in flexion using angular measurement and the Tubiana score | Other | Patient with Dupuytren's disease |
Primary outcome
Use of surgery (yes/no)
Time frame: 3 years
Use of surgery within 3 years following treatment by percutaneous needle aponeurotomy for Dupuytren's disease. the result is yes or not.
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 20 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires and Clinical examination in people with Dupuytren's Disease, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 8 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: opening soon, as of the sponsor's last update on 20 Jan 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 France. 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 Jean-François Oudet, M (0033683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of surgery (yes/no) (time frame: 3 years). 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 20 Jan 2026.