NCT05067764 Efficacy of Aponeurectomy on the 2-year Recurrence Rate of Dupuytren's Disease
| NCT ID | NCT05067764 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Elsan |
| Condition | Dupuytren's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 172 participants |
| Start Date | 2022-09-29 |
| Primary Completion | 2027-03-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 172 participants in total. It began in 2022-09-29 with a primary completion date of 2027-03-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Dupuytren's disease is a frequent hereditary disease in Northern Europe. It is a degenerative disease affecting the palmar aponeurosis of the hand. It develops a progressive contractile fibrosis which cuts the hypodermic fatty tissue, adheres to the skin and the phalanges, gradually bending the affected rays, resulting in significant functional impotence. Various medical and surgical treatments are available.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Carrier of Tubiana stage II-IV Dupuytren's disease on at least one or more rays, not previously 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 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 coordinating center, not applicable for other centers)
Contact & Investigator
Elias SAWAYA, MD
PRINCIPAL INVESTIGATOR
Institut Aquitain de la Main
Frequently Asked Questions
Who can join the NCT05067764 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dupuytren's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05067764 currently recruiting?
Yes, NCT05067764 is actively recruiting participants. Contact the research team at esawaya.md@gmail.com for enrollment information.
Where is the NCT05067764 trial being conducted?
This trial is being conducted at Pessac, France, Saint-Herblain, France.
Who is sponsoring the NCT05067764 clinical trial?
NCT05067764 is sponsored by Elsan. The principal investigator is Elias SAWAYA, MD at Institut Aquitain de la Main. The trial plans to enroll 172 participants.