Last updated: August 23, 2023
Sponsor: Elsan
Overall Status: Active - Recruiting
Phase
N/A
Condition
Dupuytren's Disease
Treatment
Aponeurectomy alone
Aponeurectomy with grafting
Clinical Study ID
NCT05067764
REMEDY
2020-A03214-35
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years
- Carrier of Tubiana stage II-IV Dupuytren's disease on at least one or more rays, notpreviously operated
- Indication of a surgery by aponeurectomy
- Skin pinch of the posterior aspect of the arm of more than 1cm
- Affiliation to a social security system
- Patient informed of the study and having given informed consent
Exclusion
Exclusion Criteria:
- Previous surgery of any kind for Dupuytren's disease
- Involvement on the thumb only
- Need for a total skin graft or a pedicle flap on all the rays to be treated
- Active autoimmune disease
- Previous treatment with collagenase
- Pregnant and breastfeeding women
- Patient under legal protection
- Contraindications to MRI (criteria applicable only for patients from the coordinatingcenter, not applicable for other centers)
Study Design
Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Aponeurectomy alone
Phase:
Study Start date:
June 13, 2022
Estimated Completion Date:
June 01, 2029
Study Description
Connect with a study center
Clinique du Diaconat
Mulhouse, 68100
FranceSite Not Available
Institut Aquitain de la Main
Pessac, 33600
FranceActive - Recruiting


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