Digital Nerve InjuryPhase 3D3NERVNCT04115982
Vitamin D3 in Sensory Recovery After Digital NERVe Suture (D3NERV).
A Phase 3 study testing Cholecalciferol in people with Digital Nerve Injury, run by University Hospital, Caen at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 51 years
- Conditions the study is for
- Digital Nerve Injury
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Jan 2020to Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 12Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Caen University Hospital
Caen, 14000
Parienti Jean-Jacques, PHD
- Recruiting
Rouen University Hospital
Rouen, 76000
Auquit-Auckbur Isabelle, PHD
- Recruiting
Institut de la main Nantes Atlantique
Saint-Herblain, 44800
Lecoq Flore-Anne, MD, 0251844884
About this study
Official title: Vitamin D3 in Sensory Recovery After Digital NERVe Suture: a Randomized Controlled Trial.
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.
- Conditions
- Digital Nerve Injury
- Being tested
- Cholecalciferol, Placebos
- Keywords
- digital nerve injury, neuroma, cholecalciferol
- Medical subject headings
- Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
One vial every 15 days during 2 months
PlacebosDrug
One vial every 15 days during 2 months
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol | Experimental | Cholecalciferol (Vitamin D3) 100 000 IU/2 mL Receives: Drug: Cholecalciferol |
| Placebo | Placebo comparator | Placebo of Cholecalciferol (Vitamine D3) 100 000 IU/2 mL Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weber test (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.
Measured: Month 6
Secondary outcomes (10)
Weber test (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.
Measured: Month 12
Resting pain on the operated finger
VAS (Visual Analogic Scale)
Measured: Month 2, Month 6, Month 12
Neuropathic pain on the operated finger
DN 4 (Neuropathic pain)
Measured: Month 2, Month 6, Month 12
Global functional outcome measure
Quick DASH
Measured: Month 2, Month 6, Month 12
Cold Intolerance
CSS (Cold Sensitivity Severity Scale)
Measured: Month 2, Month 6, Month 12
Cold Intolerance at work
PWES (Potential Work Exposure Scale)
Measured: Month 2, Month 6, Month 12
Quality-of-life measure
SF-36 (Study Short form 36)
Measured: Month 2, Month 6, Month 12
Return-to-work time frames
Time before returning to work
Measured: Month 2
Vitamin D blood level
Measured: at inclusion, Month 2
Adverse event and complication
Existence of neuroma, existence of medical complication, existence of overdosage of Cholecalciferol and every other adverse event
Measured: Trough study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start20 Jan 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Digital Nerve InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115982
- Sponsor's protocol ID
- 17-237
- Other IDs
- 2018-001526-26, 2018
- Acronym
- D3NERV
- Status last verified
- Jul 2021
- First submitted
- 19 Aug 2019
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
al-Ghazal SK, McKiernan M, Khan K, McCann J. Results of clinical assessment after primary digital nerve repair. J Hand Surg Br. 1994 Apr;19(2):255-7. doi: 10.1016/0266-7681(94)90180-5.
PubMed 8014564Alligand-Perrin P, Rabarin F, Jeudy J, Cesari B, Saint-Cast Y, Fouque PA, Raimbeau G. Vein conduit associated with microsurgical suture for complete collateral digital nerve severance. Orthop Traumatol Surg Res. 2011 Jun;97(4 Suppl):S16-20. doi: 10.1016/j.otsr.2011.03.012. Epub 2011 Apr 30.
PubMed 21531189Arnaout A, Fontaine C, Chantelot C. Sensory recovery after primary repair of palmar digital nerves using a Revolnerv((R)) collagen conduit: a prospective series of 27 cases. Chir Main. 2014 Sep;33(4):279-85. doi: 10.1016/j.main.2014.05.002. Epub 2014 Jun 18.
PubMed 25169199Barrueto F Jr, Wang-Flores HH, Howland MA, Hoffman RS, Nelson LS. Acute vitamin D intoxication in a child. Pediatrics. 2005 Sep;116(3):e453-6. doi: 10.1542/peds.2004-2580.
PubMed 16140692Battiston B, Geuna S, Ferrero M, Tos P. Nerve repair by means of tubulization: literature review and personal clinical experience comparing biological and synthetic conduits for sensory nerve repair. Microsurgery. 2005;25(4):258-67. doi: 10.1002/micr.20127.
PubMed 15934044Bertleff MJ, Meek MF, Nicolai JP. A prospective clinical evaluation of biodegradable neurolac nerve guides for sensory nerve repair in the hand. J Hand Surg Am. 2005 May;30(3):513-8. doi: 10.1016/j.jhsa.2004.12.009.
PubMed 15925161Chabas JF, Stephan D, Marqueste T, Garcia S, Lavaut MN, Nguyen C, Legre R, Khrestchatisky M, Decherchi P, Feron F. Cholecalciferol (vitamin D(3)) improves myelination and recovery after nerve injury. PLoS One. 2013 May 31;8(5):e65034. doi: 10.1371/journal.pone.0065034. Print 2013.
PubMed 23741446Heaney RP, Davies KM, Chen TC, Holick MF, Barger-Lux MJ. Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol. Am J Clin Nutr. 2003 Jan;77(1):204-10. doi: 10.1093/ajcn/77.1.204.
PubMed 12499343Neubrech F, Heider S, Otte M, Hirche C, Kneser U, Kremer T. [Nerve Tubes for the Repair of Traumatic Sensory Nerve Lesions of the Hand: Review and Planning Study for a Randomised Controlled Multicentre Trial]. Handchir Mikrochir Plast Chir. 2016 Jun;48(3):148-54. doi: 10.1055/s-0042-104505. Epub 2016 Jun 16. German.
PubMed 27311073Finnell JT, Knopp R, Johnson P, Holland PC, Schubert W. A calibrated paper clip is a reliable measure of two-point discrimination. Acad Emerg Med. 2004 Jun;11(6):710-4.
PubMed 15175216Gueye Y, Marqueste T, Maurel F, Khrestchatisky M, Decherchi P, Feron F. Cholecalciferol (vitamin D(3)) improves functional recovery when delivered during the acute phase after a spinal cord trauma. J Steroid Biochem Mol Biol. 2015 Nov;154:23-31. doi: 10.1016/j.jsbmb.2015.06.007. Epub 2015 Jul 6.
PubMed 26159913Barger-Lux MJ, Heaney RP. Effects of above average summer sun exposure on serum 25-hydroxyvitamin D and calcium absorption. J Clin Endocrinol Metab. 2002 Nov;87(11):4952-6. doi: 10.1210/jc.2002-020636.
PubMed 12414856Lundborg G, Rosen B. The two-point discrimination test--time for a re-appraisal? J Hand Surg Br. 2004 Oct;29(5):418-22. doi: 10.1016/j.jhsb.2004.02.008.
PubMed 15336741Fakin RM, Calcagni M, Klein HJ, Giovanoli P. Long-term clinical outcome after epineural coaptation of digital nerves. J Hand Surg Eur Vol. 2016 Feb;41(2):148-54. doi: 10.1177/1753193415578986. Epub 2015 Mar 31.
PubMed 25827143Manoli T, Schiefer JL, Schulz L, Fuchsberger T, Schaller HE. Influence of immobilization and sensory re-education on the sensory recovery after reconstruction of digital nerves with direct suture or muscle-in-vein conduits. Neural Regen Res. 2016 Feb;11(2):338-44. doi: 10.4103/1673-5374.169638.
PubMed 27073390
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D3 in Sensory Recovery After Digital NERVe Suture: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04115982
- Acronym / sponsor ID
- D3NERV / 17-237
- Conditions
- Digital Nerve Injury
- Keywords
- digital nerve injury, neuroma, cholecalciferol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 4 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol | Experimental | Drug: CholecalciferolCholecalciferol (Vitamin D3) 100 000 IU/2 mL |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo of Cholecalciferol (Vitamine D3) 100 000 IU/2 mL |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecalciferolOne vial every 15 days during 2 months | Drug | Cholecalciferol |
| PlacebosOne vial every 15 days during 2 months | Drug | Placebo |
Primary outcome
Weber test (Month 6)
Time frame: 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.
10 secondary outcomes
Weber test (Month 12)
Time frame: Month 12
Resting pain on the operated finger
Time frame: Month 2, Month 6, Month 12
Neuropathic pain on the operated finger
Time frame: Month 2, Month 6, Month 12
Global functional outcome measure
Time frame: Month 2, Month 6, Month 12
Cold Intolerance
Time frame: Month 2, Month 6, Month 12
Cold Intolerance at work
Time frame: Month 2, Month 6, Month 12
Quality-of-life measure
Time frame: Month 2, Month 6, Month 12
Return-to-work time frames
Time frame: Month 2
Vitamin D blood level
Time frame: at inclusion, Month 2
Adverse event and complication
Time frame: Trough study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Background: PubMed 8014564al-Ghazal SK, McKiernan M, Khan K, McCann J. Results of clinical assessment after primary digital nerve repair. J Hand Surg Br. 1994 Apr;19(2):255-7. doi: 10.1016/0266-7681(94)90180-5.
- Background: PubMed 21531189Alligand-Perrin P, Rabarin F, Jeudy J, Cesari B, Saint-Cast Y, Fouque PA, Raimbeau G. Vein conduit associated with microsurgical suture for complete collateral digital nerve severance. Orthop Traumatol Surg Res. 2011 Jun;97(4 Suppl):S16-20. doi: 10.1016/j.otsr.2011.03.012. Epub 2011 Apr 30.
- Background: PubMed 25169199Arnaout A, Fontaine C, Chantelot C. Sensory recovery after primary repair of palmar digital nerves using a Revolnerv((R)) collagen conduit: a prospective series of 27 cases. Chir Main. 2014 Sep;33(4):279-85. doi: 10.1016/j.main.2014.05.002. Epub 2014 Jun 18.
- Background: PubMed 16140692Barrueto F Jr, Wang-Flores HH, Howland MA, Hoffman RS, Nelson LS. Acute vitamin D intoxication in a child. Pediatrics. 2005 Sep;116(3):e453-6. doi: 10.1542/peds.2004-2580.
- Background: PubMed 15934044Battiston B, Geuna S, Ferrero M, Tos P. Nerve repair by means of tubulization: literature review and personal clinical experience comparing biological and synthetic conduits for sensory nerve repair. Microsurgery. 2005;25(4):258-67. doi: 10.1002/micr.20127.
- Background: PubMed 15925161Bertleff MJ, Meek MF, Nicolai JP. A prospective clinical evaluation of biodegradable neurolac nerve guides for sensory nerve repair in the hand. J Hand Surg Am. 2005 May;30(3):513-8. doi: 10.1016/j.jhsa.2004.12.009.
- Background: PubMed 23741446Chabas JF, Stephan D, Marqueste T, Garcia S, Lavaut MN, Nguyen C, Legre R, Khrestchatisky M, Decherchi P, Feron F. Cholecalciferol (vitamin D(3)) improves myelination and recovery after nerve injury. PLoS One. 2013 May 31;8(5):e65034. doi: 10.1371/journal.pone.0065034. Print 2013.
- Background: PubMed 12499343Heaney RP, Davies KM, Chen TC, Holick MF, Barger-Lux MJ. Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol. Am J Clin Nutr. 2003 Jan;77(1):204-10. doi: 10.1093/ajcn/77.1.204.
- Background: PubMed 27311073Neubrech F, Heider S, Otte M, Hirche C, Kneser U, Kremer T. [Nerve Tubes for the Repair of Traumatic Sensory Nerve Lesions of the Hand: Review and Planning Study for a Randomised Controlled Multicentre Trial]. Handchir Mikrochir Plast Chir. 2016 Jun;48(3):148-54. doi: 10.1055/s-0042-104505. Epub 2016 Jun 16. German.
- Background: PubMed 15175216Finnell JT, Knopp R, Johnson P, Holland PC, Schubert W. A calibrated paper clip is a reliable measure of two-point discrimination. Acad Emerg Med. 2004 Jun;11(6):710-4.
- Background: PubMed 26159913Gueye Y, Marqueste T, Maurel F, Khrestchatisky M, Decherchi P, Feron F. Cholecalciferol (vitamin D(3)) improves functional recovery when delivered during the acute phase after a spinal cord trauma. J Steroid Biochem Mol Biol. 2015 Nov;154:23-31. doi: 10.1016/j.jsbmb.2015.06.007. Epub 2015 Jul 6.
- Background: PubMed 12414856Barger-Lux MJ, Heaney RP. Effects of above average summer sun exposure on serum 25-hydroxyvitamin D and calcium absorption. J Clin Endocrinol Metab. 2002 Nov;87(11):4952-6. doi: 10.1210/jc.2002-020636.
Related trials for Digital Nerve Injury
RecruitingObservational study
Sensory Neurography and S2PD After Digital Nerve Injury
Digital Nerve Injury, Sensory Neurography
RecruitingPhase 2
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain
Not yet recruiting
SECURE Post-Market Study
Digital Nerve Injury
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
Active, not recruiting
Rapid Entrainment and Signal-guided Neuromodulation for Behavioral Health
Anxiety, PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cholecalciferol in people with Digital Nerve Injury, run by University Hospital, Caen at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flore-Anne Lecoq, MD (+33251848884, flore.lecoq@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weber test (Month 6) (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04115982, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.