Universitaire Ziekenhuizen KU Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
Location contact
Anna Tarasiuk
CONTACT
Ilse Degreef, Prof. Dr.
CONTACT
Ilse Degreef, Prof. Dr.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06956027
Dupuytren's disease (DD) is a benign and progressive condition that affects the palmar aponeurosis with a very high global incidence. It can result in significant loss of hand function or can inhibit an individual's daily activities or work. Current diagnostics rely on Range Of Motion (ROM) measurements and clinical expertise, where the decision for treatment is primarily based on patient preferences with little scientific research supporting different options in different cases.
With technological advancements new options arise to the possible diagnostic tools that can be used for evidence based medicine and shared decision making. One option comes to light for DD because of its cheap, non -invasive and no radiation load, namely ultrasound (US). The use of US for DD is not standard care, due to the lack of research surrounding this tool. This study will provide some insight into the use of US for DD and will primarily try to evaluate different parameters measurable with US that can be used as potential prognostic biomarkers.
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Interventional
Not applicable
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
Anna Tarasiuk
CONTACT
Ilse Degreef, Prof. Dr.
CONTACT
Ilse Degreef, Prof. Dr.
PRINCIPAL_INVESTIGATOR
Dupuytren's disease (DD) is a benign and progressive condition that affects the palmar aponeurosis with a very high global incidence. It can result in significant loss of hand function or can inhibit an individual's daily activities or work. The diagnostic tool that is currently used the most is the clinical evaluation of a hand surgeon, and also the use of a goniometer which measures the total Range of Motion (ROM) a patient still has in his finger, where the decision for treatment is primarily based on patient preferences with little scientific research supporting different options in different cases. Due to a lack of patient satisfaction and high recurrence rates among those who underwent surgery there is a clear need for more knowledge surrounding DD to better understand this disease. This will lead to new possibilities in the field of research and the potential for new treatments.
With technological advancements new options arise to the possible diagnostic tools that can be used for evidence based medicine and shared decision making. One option comes to light for DD because of its cheap, non -invasive and no radiation load, namely ultrasound (US). The use of US for DD is not standard care, due to the lack of research surrounding this tool. This study will provide some insight into the use of US for DD and will primarily try to evaluate different parameters measurable with US that can be used as potential prognostic biomarkers. Three different characteristics will be measured: echogenicity, skin involvement, the presence of microvascular structures. In summary, the mentioned parameters could possibly prove to be useful in the assessment of DD patients and could make US a standard in determining disease progression and could make the consideration between different treatment options more evidence based.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound image taken using MV-flow technique for measuring the distance skin-lesion and echogenicity measurement
Range Of Motion measurement of affected finger(s) where the ultrasound image will be taken from.
Time frame: At screening and at 6 month follow-up visit
A biomarker measured with an ultrasound device that shows high myofibroblast presence (=hypoechogenic) or high collagen in the extracellular matrix (mean gray value).
Time frame: At screening and at 6 month follow-up visit
This measurement shows skin involvement in the disease which will influence how it evolves (in millimeters).
Time frame: At screening and at 6 month follow-up visit
Determine the presence of microvascularisation inside the DD nodule. The presence of this vascularisation could be indicative of faster progression. (Answered with Yes or No)
Time frame: At screening and at 6 month follow-up visit
The Total Passive Extension Deficit (PED) will be measured using a digital goniometer (in degrees). Disease progression when increase is ≥ 5°
Time frame: At screening and at 6 month follow-up visit
The URAM questionnaire is used to determine progression for subject's own experience with the disease. Disease progression if URAM questionnaire score increases with 1 or more points (Minimum score = 0; Maximum score = 45)
Time frame: At screening and at 6 month follow-up visit
This score goes from 0 till 9. To investigate if a high score (≥ 4) correlates with faster disease progression.
Time frame: At screening and at 6 month follow-up visit
The amount of participants with microvascularisation (given in %)
Contact information is provided by the study sponsor or research team.
Anna Tarasiuk
CONTACT
Ilse Degreef, Prof. Dr.
CONTACT
Universitaire Ziekenhuizen KU Leuven
Other
Ultrasound Features of Dupuytren's Disease: Echogenicity, Skin Involvement and Microvascularisation
Acronym: Micro in DD
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