The primary aim of this study is to gain knowledge on the natural course of Dupuytren's disease, in adults with various Dupuytren disease stages. Secondary aims are: - Gain insight in course after treatment- Determine whether there are riskā¦
ID
Source
Brief title
Condition
- Connective tissue disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The natural course of progression of Dupuytren*s disease, defined as the
increase in size of nodules and cords in millimetres and/or increase of total
passive extension deficit in degrees and/or a change in echogenicity of the
nodules and/or a change in nodule hardness.
Secondary outcome
- Patient questionnaire on functional complaints (URAM-scale DLV)
- presence and course of recurrent disease, defined as the development or
change iof nodules and cords in millimetres and/or increase of total passive
extension deficit in degrees.
- Echogenicity of the nodules
- Hardness of the nodules
Background summary
Dupuytren's disease is a progressive fibroproliferative disease. It starts with
subcutaneous nodules and pitting in the palm. Later cords appear that connect
the nodules and contract the fingers into a flexed position. Usually the
deformities are located on the ulnar side of the hand and the fourth digit is
more often affected. It can develop and affect a single, but also in multiple
adjacent joints, whereby metacarpophalangeal (MP) joints, proximal
interphalangeal (PIP) joints and distal interphalangeal (DIP) joints can be
involved. It can also affect the subcutaneous tissue and skin.
Some people will only have small lumps, while others will develop a severe
contracture of the finger(s), so progression is unpredictable. There is paucity
of knowledge about the natural progression of the disease.
Study objective
The primary aim of this study is to gain knowledge on the natural course of
Dupuytren's disease, in adults with various Dupuytren disease stages.
Secondary aims are:
- Gain insight in course after treatment
- Determine whether there are risk factors for progression or recurrence
- Determine at what disease extent / contracture extent patients will report
functional complaints
- Determine inter- and intra-observer reliability of the measurements
- Determine whether different methods of measuring contractures yield similar
results, and whether this can be derived from each other
Study design
Observational pilot study (longitudinal prospective cohort).
Study burden and risks
This observational study investigates the natural disease progression of
Dupuytren*s disease, without interference in the treatment plan. The only
measurements are a physical examination of both hands, a short questionnaire at
every moment of follow-up and collection of 20 ml of blood once. The potential
benefit for participants is that a sudden increase of disease progression or
recurrent disease will be noted early and that treatment will not be delayed.
The benefit for patients with DD in general is that our knowledge about natural
disease progress enhances and that in the future treatment can be modified
based on this new knowledge.
The additional measurement of recurrent disease does not require extra time of
the participant, and there are no risks associated with this measurement.
The addition of an extra measurement to determine the intra-observer and
interobserver reliability, increases the burden for the patient. However, only
a random subsample of the total group will be asked to participate in this
additional measurement. They have the opportunity to deny participation. If the
patient is not willing to participate in this extra measurement, nothing will
change with respect to the standard research protocol.
The ultrasonography and tonometry are not harmful, but participants will have
the opportunity to refuse these additional measurements.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Presence of primary Dupuytren's disease
Exclusion criteria
Patients who are incapable of giving informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT01923103 |
CCMO | NL39188.042.11 |