UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
Location contact
Anna Tarasiuk
CONTACT
Ilse Degreef, Prof. Dr.
CONTACT
NCT Number: NCT06321991
Dupuytren disease (DD) is a common hand disorder with disabling finger contractures that may require surgery to restore function. In the early stages of the disease, the nodules (Tubiana stage 0) are usually painless, but a reason for concern to many patients. Not rarely, lifestyle measures and even risky treatment options as radiotherapy are advised, yet no therapy to prevent disease evolution has a solid proven effect. Furthermore, reliable non-invasive measurement of early stage DD is not validated.
Evidence was found that pharmacotherapy may influence DD evolution, but valuable clinical trials are limited. Case series and non-published explorative follow-up suggested local treatment with antioxidant vitamin E to possibly interfere with an evolution of DD nodules to contracting strands. This study aims to provide evidence on efficiency of this non-invasive treatment option.
Secure measurement of nodule evolution is a clinical challenge. To measure this evolution, ultrasound and MRI scanning are currently being performed. Stage 0 (nodules) is more challenging to quantify. A strict individual follow-up by the treating clinician is needed to standardize measurement of selected (treated) nodules. Therefore, simple ultrasound by the treating clinician may provide an good tool to collect data. This study aims to introduce and validate this non-invasive scan method and provide a prospective double blind investigation of a measurable effect of non-invasive preventive treatment for stage 0 DD to improve clinical outcome.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
Anna Tarasiuk
CONTACT
Ilse Degreef, Prof. Dr.
CONTACT
Dupuytren disease (DD) is a common hand disorder with disabling finger contractures that may require surgery to restore function. The contractures are caused by progressive fibroproliferative tissue forming nodules and strands in the palmar fascia that eventually cause loss of finger extension. In the early stages of the disease, the nodules (Tubiana stage 0) are usually painless, but a reason for concern to many patients. They often seek the hand surgeon's advice and worry about losing hand function the coming years, commonly requesting for precautionary measures to stop evolution towards contractures (Tubiana stage 1-4). Not rarely, lifestyle measures and even risky treatment options as radiotherapy are advised, yet no therapy to prevent disease evolution has a solid proven effect. Furthermore, reliable non-invasive measurement of early stage DD is not validated.
However, this is needed to explore any efficient preventive treatment that may be cost-efficient for patients and healthcare.
Evidence was found that pharmacotherapy may influence DD evolution, but valuable clinical trials are limited. Case series and non-published explorative follow-up suggested local treatment with antioxidant vitamin E to possibly interfere with an evolution of DD nodules to contracting strands. Therefore, it is recommended to consider local creams to the palms in such situation.
This study aims to provide evidence on efficiency of this non-invasive treatment option. Secure measurement of nodule evolution is a clinical challenge. To measure this evolution, ultrasound and MRI scanning are currently being performed. In clinical practice, although clinical staging of contractures is reliable, stage 0 (nodules) is more challenging to quantify. If observed, nodules (evolution) are often measured by clinical yardstick assessment. However, this technique is unvalidated and unreliable with inevitable significant inter- and intra-observer unreliability, which may improve with sonography. A strict individual follow-up by the treating clinician is needed to standardize measurement of selected (treated) nodules. Therefore, simple ultrasound by the treating clinician may provide an good tool to collect data. The V-Scan (simple office-based Bluetooth ultrasonography) may aid to achieve this and its use is successfully implemented since 1 year at the hand Surgery department at Université Catholique de Louvain (UCL) by and under supervision of Prof Dr X. Libouton.
This study aims to introduce and validate this non-invasive scan method and provide a prospective double blind investigation of a measurable effect of non-invasive preventive treatment for stage 0 DD to improve clinical outcome.
Rationale: Application of antioxidant creme cause V-scan measurable arrest or even shrinking of the nodules in stage 0 of DD.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Louis Widmer Remederm® Face Cream Without Perfume 50 ml is a skin care product that contains vitamin E as an active ingredient. Before applying Remederm®, the following are advised: On dry clean skin thoroughly before applying Remederm®, apply a layer of cream cutaneous to the hand palm, twice a day: morning and evening, massage cream into skin until absorbed. This procedure is applied by the patient treated with Vaseline or Remederm®.
Nodule evolution will be measured with ultrasound.
Time frame: 1 year
A significant downsize (>1mm because V-scan (ultrasonography) is accurate to 1mm) of the largest nodule diameter in the palm of the hand.
Time frame: 1 year
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The patient is asked to rate their current level of pain by placing a mark on the line.
Time frame: 1 year
The Visual Analogue Scale (VAS) measures satisfaction. The VAS consists of a 10cm line, with two end points representing 0 ('complete dissatisfaction') and 10 ('full satisfaction'). The patient is asked to rate their current level of satisfaction by placing a mark on the line.
Time frame: 1 year
This questionnaire asks the patient about the symptoms as well as the ability to perform certain activities. It consists of 11 items ranging from 1 ('not at all/no difficulty') to 5 ('extremely/unable').
Time frame: Baseline
An objective method to evaluate the risk of recurrence and extension of Dupuytren's disease. This scoring counts 1 point for each for bilateral, small finger surgery and if onset < 50 y. The scoring counts 2 points each for Ledderhose, knuckle pads, thumb / index disease. Diathesis score = sum of points. Increased risk for score > 4.
Time frame: 1 year
By using goniometry of Distal interphalangeal, Proximal Interphalangeal and metacarpophalangeal joints
Time frame: 1 year
Recurrence is defined as the clinical re-appearance of the treated nodules or a significant increase of diameter (>1mm) or evolution to a higher stage (Tubiana stage 1-4) of the disease than 0 at intake.
Contact information is provided by the study sponsor or research team.
Anna Tarasiuk
CONTACT
Ilse Degreef, Prof. Dr.
CONTACT
Universitaire Ziekenhuizen KU Leuven
Other
Nodular Shrinking in Stage 0 Dupuytren Disease: an Evidence-based Approach for Early Stage Treatment to Prevent Progression to Advanced Finger Contractures
Acronym: Echo
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05067764
Connective Tissue Diseases, Contracture
Pessac, France
View Trial DetailsNCT04122313
Connective Tissue Diseases, Contracture
Minneapolis, Minnesota, United States
View Trial DetailsNCT06142929
Connective Tissue Diseases, Contracture
Leuven, Vlaams-Brabant, Belgium
View Trial DetailsNCT05300893
Connective Tissue Diseases, Contracture
Falun, Dalarna County, Sweden
View Trial Details