Dupuytren ContractureDDNCT01923103
Natural Disease Progress of Dupuytren Disease
An observational study of Dupuytren Contracture and Disease Progression, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Dupuytren disease (DD) is a progressive fibromatosis of the palmar fascias of the hand and fingers, which may lead to extension deficits of the fingers. The disease can be very disabling in moderate and severe cases, whereby performing normal daily activities can become very problematic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren Contracture, Disease Progression
- How many people
- 261 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jun 2012to 20 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 with Dupuytren Disease who participated in prior studies and patients from the outpatient clinic
Who may be able to join
- Patients (> 18 years of age) with primary Dupuytren's disease in all Tubiana stages
- Operated hands of patients with primary Dupuytren's disease on the contra lateral hand
Who cannot join
- Patients who are incapable of giving consent
- Patients who are not able or not willing to visit the UMCG for follow-up
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Trial locations and contacts
1 site in 1 country.
About this study
Dupuytren disease (DD) is a progressive fibromatosis of the palmar fascias of the hand and fingers, which may lead to extension deficits of the fingers. The disease can be very disabling in moderate and severe cases, whereby performing normal daily activities can become very problematic. The aetiology and pathogenesis are not completely understood. There is a genetic disposition and it is influenced by environmental factors. The disease is especially prevalent in white males of Northern European descent above 50 years of age. There is paucity of knowledge about the natural progression of the disease. Several studies have been conducted on progression of disease and from these studies it becomes obvious that the disease is progressive over several years. However, in most studies only one moment of follow-up has taken place, so the course of the progression over time is unknown.
The aim of this study is to enhance our knowledge on the natural disease progression of DD at different stages.
Read the detailed description
Objective:
- Primary objective: To study natural disease progress of Dupuytren Disease (DD) in different stages of disease in males and females above 18 years of age.
- Secondary objectives:
- To study the effect of potential risk factors for DD on natural disease progress.
- To study at what stage of disease patients with DD experience problems in daily life.
- To study the incidence and course of recurrent disease. Primary Hypothesis: The natural course of disease is an exponential function of time.
- To study the intrarater reliability of the measurements
- To determine whether the echogenicity of the nodules can predict progression g. To determine whether extension deficit measurements can be replaced by measurements of extension, and whether this will facilitate the statistical analysis h. To determine the association between passive and active measurements of extension and extension deficit, and to see whether active measurements can be derived from passive measurements and vice versa.
- Study design: The study is designed as a prospective observational pilot study with a follow-up of 10 years.
- Study population: Males and females above 18 years of age with all stages of primary Dupuytren's disease in at least one hand
- Main study parameters/endpoints: The natural course of progression of DD measured as the increase or decrease in size of nodules and cords in millimetres and/or increase of total passive extension deficit in degrees, from baseline to endpoint.
- Secondary study parameters:
- Patient-reported hand function (Michigan Hand Outcomes Questionnaire (MHOQ), Patient-Rated Wrist/Hand Evaluation (PRWHE) and Unité Rhumatologique des Affections de la Main (URAM) scale
- incidence and course of recurrent disease
- disease activity (ultrasonography and tonometry)
- Procedure Patients visit the outpatient clinic every 6 months (first 5 years of follow-up) and later on every 12 months (last 5 years of follow-up) for an anamnestic interview, physical examination of the hands, ultrasonography, tonometry and for filling out the PROMs.
- Conditions
- Dupuytren Contracture, Disease Progression
- Medical subject headings
- Dupuytren Contracture, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
The course of DD: passive and active extension deficit and dimension of palpable nodules and cords
Active and passive extension deficit is measured with a goniometer at joint level Dimension of nodules and cords is measured using a tumorimeter
Measured: every 6-12 months
Secondary outcomes (2)
Disease activity: Echogenicity and nodule hardness
Activity of a nodule is determined by 1) echogenicity of the ultrasound image in sagittal and transversal plane, 2) hardness of the nodule determined by tonometry
Measured: every 12 months, starting from 2016 (ultrasound) and 2018 (tonometry)
Patient-reported hand function: MHQ, PRWHE and URAM
To study what problems patients with DD experience in daily life, PROMs are used. MHQ and PRWHE in the first 2 years, URAM later on
Measured: every 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study start22 Jun 2012
- Primary completionMar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren ContractureStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D.C. Broekstra, University Medical Center Groningen
- Investigators
- Paul MN Werker, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923103
- Sponsor's protocol ID
- NDPDD
- Acronym
- DD
- Status last verified
- Dec 2023
- First submitted
- 9 Aug 2013
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan available, but we are open for collaboration
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Disease Progress of Dupuytren Disease
- ClinicalTrials.gov ID
- NCT01923103
- Acronym / sponsor ID
- DD / NDPDD
- Conditions
- Dupuytren Contracture, Disease Progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 22 Jun 2012 (actual)
- Primary completion
- Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 14 Aug 2013 (estimated)
- 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 progressive fibromatosis of the palmar fascias of the hand and fingers, which may lead to extension deficits of the fingers. The disease can be very disabling in moderate and severe cases, whereby performing normal daily activities can become very problematic. The aetiology and pathogenesis are not completely understood. There is a genetic disposition and it is influenced by environmental factors. The disease is especially prevalent in white males of Northern European descent above 50 years of age. There is paucity of knowledge about the natural progression of the disease. Several studies have been conducted on progression of disease and from these studies it becomes obvious that the disease is progressive over several years. However, in most studies only one moment of follow-up has taken place, so the course of the progression over time is unknown.
The aim of this study is to enhance our knowledge on the natural disease progression of DD at different stages.
Detailed description
Objective:
- Primary objective: To study natural disease progress of Dupuytren Disease (DD) in different stages of disease in males and females above 18 years of age.
- Secondary objectives:
- To study the effect of potential risk factors for DD on natural disease progress.
- To study at what stage of disease patients with DD experience problems in daily life.
- To study the incidence and course of recurrent disease. Primary Hypothesis: The natural course of disease is an exponential function of time.
- To study the intrarater reliability of the measurements
- To determine whether the echogenicity of the nodules can predict progression g. To determine whether extension deficit measurements can be replaced by measurements of extension, and whether this will facilitate the statistical analysis h. To determine the association between passive and active measurements of extension and extension deficit, and to see whether active measurements can be derived from passive measurements and vice versa.
- Study design: The study is designed as a prospective observational pilot study with a follow-up of 10 years.
- Study population: Males and females above 18 years of age with all stages of primary Dupuytren's disease in at least one hand
- Main study parameters/endpoints: The natural course of progression of DD measured as the increase or decrease in size of nodules and cords in millimetres and/or increase of total passive extension deficit in degrees, from baseline to endpoint.
- Secondary study parameters:
- Patient-reported hand function (Michigan Hand Outcomes Questionnaire (MHOQ), Patient-Rated Wrist/Hand Evaluation (PRWHE) and Unité Rhumatologique des Affections de la Main (URAM) scale
- incidence and course of recurrent disease
- disease activity (ultrasonography and tonometry)
- Procedure Patients visit the outpatient clinic every 6 months (first 5 years of follow-up) and later on every 12 months (last 5 years of follow-up) for an anamnestic interview, physical examination of the hands, ultrasonography, tonometry and for filling out the PROMs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Dupuytren Disease who participated in prior studies and patients from the outpatient clinic
Key inclusion criteria (2 listed)
- Patients (> 18 years of age) with primary Dupuytren's disease in all Tubiana stages
- Operated hands of patients with primary Dupuytren's disease on the contra lateral hand
Key exclusion criteria (3 listed)
- Patients who are incapable of giving consent
- Patients who are not able or not willing to visit the UMCG for follow-up
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The course of DD: passive and active extension deficit and dimension of palpable nodules and cords
Time frame: every 6-12 months
Active and passive extension deficit is measured with a goniometer at joint level Dimension of nodules and cords is measured using a tumorimeter
2 secondary outcomes
Disease activity: Echogenicity and nodule hardness
Time frame: every 12 months, starting from 2016 (ultrasound) and 2018 (tonometry)
Patient-reported hand function: MHQ, PRWHE and URAM
Time frame: every 6-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No. There is no plan available, but we are open for collaboration
Related trials for Dupuytren Contracture
Not yet recruiting
Kinesitherapy Plus Osteopathy After Surgery for Dupuytren Disease
Dupuytren Disease
Not yet recruitingPhase 3
DEPART Study at Yale
Dupuytren's Contracture
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
Recruiting
Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release
Dupuytren Contracture
Not yet recruitingPhase 2
NAC-REPAIR for Post-surgical Pain
Carpal Tunnel Surgery, Trigger Finger Disorder
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. This study is not recruiting at the moment.
Paul MN Werker, PhD principal investigator
University Medical Center Groningen
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 Contracture and Disease Progression, run by University Medical Center Groningen at 1 site in Netherlands.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 5 Dec 2023. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The course of DD: passive and active extension deficit and dimension of palpable nodules and cords (time frame: every 6-12 months). 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 5 Dec 2023.