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Trial Title:
Nodular Shrinking in Dupuytren Disease
NCT ID:
NCT06321991
Condition:
Dupuytren's Disease
Conditions: Official terms:
Dupuytren Contracture
Vitamin E
Petrolatum
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Simple random allocation will be ensured by the principal investigators' designated staff
(study nurse of IORT), who will not be involved in recruiting trial participants, medical
care, drug administration or follow-up, through the generation of a random numbers table
with computer software program. A randomization list will be prepared by the Sponsor's
designated staff, not involved in recruiting Trial participants, medical care, drug
administration or follow-up.
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking description:
To avoid bias, treatment arms will be blinded to Investigators, Trial staff,
participants,.. as follows: vitamin E creme will be packaged and labelled in such a way
that the visual appearance, nor the smell and/or touch of the creme can be distinguished
from placebo (Vaseline).
Intervention:
Intervention type:
Drug
Intervention name:
Vitamin E-creme (Remederm®) vs Vaseline (Placebo)
Description:
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®.
Arm group label:
Dupuytren Disease patients receiving Remederm® (Vitamine E creme)
Arm group label:
Dupuytren Disease patients receiving Vasiline (Placebo)
Intervention type:
Procedure
Intervention name:
Ultrasound measurement
Description:
Nodule evolution will be measured with ultrasound.
Arm group label:
Dupuytren Disease patients receiving Remederm® (Vitamine E creme)
Arm group label:
Dupuytren Disease patients receiving Vasiline (Placebo)
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Ilse Degreef, Prof. Dr.
Phone:
+3216338843
Email:
ilse.degreef@uzleuven.be
Contact backup:
Last name:
Anna Tarasiuk
Phone:
+3216338818
Email:
orthopedie.research@uzleuven.be
Start date:
February 15, 2024
Completion date:
March 1, 2026
Lead sponsor:
Agency:
Universitaire Ziekenhuizen KU Leuven
Agency class:
Other
Source:
Universitaire Ziekenhuizen KU Leuven
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06321991