Nodular Shrinking in Dupuytren Disease

Dupuytren's Disease Clinical Trial

— Echo  

Official title:

Nodular Shrinking in Stage 0 Dupuytren Disease: an Evidence-based Approach for Early Stage Treatment to Prevent Progression to Advanced Finger Contractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321991
• Other study ID #: S68382
• Status: Recruiting
• Phase: Phase 2
• Start date: February 15, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Ilse Degreef, Prof. Dr.
• Phone: +3216338843
• Email: ilse.degreef[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The participant or his/her legally authorized representative voluntary signed the informed consent prior to the first assessment.
• Participants are = 18 years and diagnosed with primary Dupuytren disease.
• Included patients have a stage 0 DD (nodule of at least 5 mm in the involved hand without contracture).
• The participant has well distinguished noduli that are clearly visible on US (ultrasound)

Exclusion Criteria:

• Patients < 18 years.
• Patient included in an interventional trial with an investigational medicinal product.
• Patients with cognitive impairments, severe rheumatic disease and neurological disorders leading to flexion deformities of the fingers.
• Patients with prior Dupuytren surgery in the involved hand.
• Patients with a higher Tubiana grading than nodular stage 0.
• Open wound in the palm of the treated hand.

Related Conditions & MeSH terms

• Dupuytren Contracture
• Dupuytren's Disease

Intervention

Drug:
• Vitamin E-creme (Remederm®) vs Vaseline (Placebo)
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®.

Procedure:
• Ultrasound measurement
Nodule evolution will be measured with ultrasound.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Downsizing of the largest nodule diameter	A significant downsize (>1mm because V-scan (ultrasonography) is accurate to 1mm) of the largest nodule diameter in the palm of the hand.	1 year
Secondary	VAS questionnaire on pain	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.	1 year
Secondary	VAS questionnaire on satisfaction	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.	1 year
Secondary	QUICK Dash for functionality	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').	1 year
Secondary	Abe Diathesis scoring	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.	Baseline
Secondary	Range of motion	By using goniometry of Distal interphalangeal, Proximal Interphalangeal and metacarpophalangeal joints	1 year
Secondary	Recurrence rate	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.	1 year