Digital Nerve Injury
Conditions
Keywords
digital nerve injury, neuroma, cholecalciferol
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 painful neuroma. Several animal studies have shown that Cholecalciferol improves axonal nerve regeneration and myelination. No study has ever been done on human subjects to evaluate the nerve regeneration after Cholecalciferol supplementation. Our hypothesis is that Cholecalciferol supplementation could improve axonal nerve regeneration and myelination after traumatic digital nerve injuries treated by microsurgical sutures and reduce the risk of hypoesthesia and neuroma.
Interventions
DRUGCholecalciferol
One vial every 15 days during 2 months
DRUGPlacebos
One vial every 15 days during 2 months
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 51 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weber test (Month 6) | Month 6 | 2 point discrimination test of Weber on the side of the fingertip concerned by the wound, comparing to the controlateral arm, after 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event and complication | Trough study completion | Existence of neuroma, existence of medical complication, existence of overdosage of Cholecalciferol and every other adverse event |
| Weber test (Month 12) | Month 12 | 2 point discrimination test of Weber on the side of the fingertip concerned by the wound, comparing to the controlateral arm, after 12 months. |
| Resting pain on the operated finger | Month 2, Month 6, Month 12 | VAS (Visual Analogic Scale) |
| Neuropathic pain on the operated finger | Month 2, Month 6, Month 12 | DN 4 (Neuropathic pain) |
| Vitamin D blood level | at inclusion, Month 2 | — |
| Cold Intolerance | Month 2, Month 6, Month 12 | CSS (Cold Sensitivity Severity Scale) |
| Cold Intolerance at work | Month 2, Month 6, Month 12 | PWES (Potential Work Exposure Scale) |
| Quality-of-life measure | Month 2, Month 6, Month 12 | SF-36 (Study Short form 36) |
| Return-to-work time frames | Month 2 | Time before returning to work |
| Global functional outcome measure | Month 2, Month 6, Month 12 | Quick DASH |
Countries
France
Contacts
Primary ContactFlore-Anne Lecoq, MD
Outcome results
None listed