Status:
UNKNOWN
Vitamin D3 in Sensory Recovery After Digital NERVe Suture (D3NERV).
Lead Sponsor:
University Hospital, Caen
Conditions:
Digital Nerve Injury
Eligibility:
All Genders
18-51 years
Phase:
PHASE3
Brief Summary
Digital nerve injuries are frequent in a FESUM center (Federation Européenne des Services d'Urgences Mains), and they need to be repaired in order to reduce the risk of hypoesthesia and to prevent pai...
Eligibility Criteria
Inclusion
- Affiliated to social security scheme,
- Wound of the palmar hand with isolated digital nerve section, requiring digital nerve microsurgical suture in the operating room by a senior surgeon,
- Signing a free and informed consent and well-informed of the study and procedure.
Exclusion
- Ischemia,
- Multiple lesion of the same nerve,
- Pregnant or nursing women,
- Contraindication of Cholecalciferol : known hypersensitivity, any history of hypercalcemia, hypercalciuria or renal lithiasis,
- Cholecalciferol supplementation in the past 6 months,
- Lesion of the same controlateral finger,
- History of nerve lesion or hypoesthesia on the same finger,
- History of previous neurological disorders with upper limb sensitivity disorder,
- Impossibility to undergo the medical follow-up because of geographical, social or psychological reason,
- Participation in another clinical trial that does not allow simultaneous participation in several clinical trials,
- Orlistat® Treatment,
- History of celiac disease.
Key Trial Info
Start Date :
January 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04115982
Start Date
January 20 2020
End Date
December 1 2022
Last Update
August 31 2021
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Caen University Hospital
Caen, France, 14000
2
Rouen University Hospital
Rouen, France, 76000
3
Institut de la main Nantes Atlantique
Saint-Herblain, France, 44800