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New treatment option for Dupuytren Disease
Official title Ultrasound Features of Dupuytren's Disease
ClinicalTrials.gov ID: NCT06956027
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Clinical diagnosis of DD and a Tubiana staging not exceeding stage II, TPED does not exceed 90°; this is chosen because to great of a contracture...
- In the clinical assessment the subject has rather soft DD nodules, more firm nodules are more fibrotic and are less likely to contain blood vessels...
- Participant has self reported rapid progression. In the anamnesis the subject reports one of the following: The DD lesion has changed in degree of...
- Participant agrees to not undergo any form of surgical treatment for DD during the duration of their participation, being 6 months.
You likely can't join if
- Participant has any other disorder or pathology of the hand/fingers that could affect the quality of US measurements. This list is exhaustive...
- Participant has received prior treatment for Dupuytren's disease (needle fasciotomy, (micro)fasciectomy) in the hand under investigation.
- Participant's affected finger exceeds a TPED over 90° (= Tubiana stage III) (this will affect the value of any US images taken)
- Participant undergoes treatment for DD during the course of their participation in this study: exhaustive list: fasciectomy/fasciotomy/stretching...
See the full eligibility criteria
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Clinical diagnosis of DD and a Tubiana staging not exceeding stage II, TPED does not exceed 90°; this is chosen because to great of a contracture will pose problems with taking the US measurement.
- In the clinical assessment the subject has rather soft DD nodules, more firm nodules are more fibrotic and are less likely to contain blood vessels. This will be confirmed by a hand surgeon at the screening phase.
- Participant has self reported rapid progression. In the anamnesis the subject reports one of the following: The DD lesion has changed in degree of contracture/nodule size recently; the patient is worried about the...
- Participant agrees to not undergo any form of surgical treatment for DD during the duration of their participation, being 6 months.
- Participant agrees to return to the clinic after 6 months voluntarily for follow-up measurements.
- Participant has any other disorder or pathology of the hand/fingers that could affect the quality of US measurements. This list is exhaustive: trigger finger, fracture, hematoma, tenosynovitis, tendon ruptures...
- Participant has received prior treatment for Dupuytren's disease (needle fasciotomy, (micro)fasciectomy) in the hand under investigation.
- Participant's affected finger exceeds a TPED over 90° (= Tubiana stage III) (this will affect the value of any US images taken)
- Participant undergoes treatment for DD during the course of their participation in this study: exhaustive list: fasciectomy/fasciotomy/stretching braces/collagenase injections
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Vlaams-Brabant, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Vlaams-Brabant, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.