Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321991
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-13
Brief Title:
Nodular Shrinking in Dupuytren Disease
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Nodular Shrinking in Stage 0 Dupuytren Disease an Evidence-based Approach for Early Stage Treatment to Prevent Progression to Advanced Finger Contractures
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Echo
Brief 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
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 surgeons 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None