Peripheral Nerve Injury Digital Nerve HandNCT03673449
Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide
A study testing SilkBridge in people with Peripheral Nerve Injury Digital Nerve Hand, run by Silk Biomaterials srl at 1 site in Switzerland.
Trial summary
The goal of this study is to ascertain the feasibility and safety of the procedure using SilkBridge - a biocompatible silk fibroin-based scaffold - for the regeneration of sensory nerve fibres and follow it up together with the reinnervation of the target organs (sensory receptors in the skin). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Nerve Injury Digital Nerve Hand
- What is being tested?
- SilkBridge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Mar 2019to Mar 2021
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male \& female patients between 18 and 65 years of age
- a traumatic injury or a post-traumatic neuroma of a digital nerve on the palmar side of the hand, between the metacarpophalangeal joint and the distal interphalangeal joint
- single lesion per finger
- nerve defect of >5mm
- nerve treatment initiated within 24 months after nerve injury
- signed informed consent
Who cannot join
- disorders known to affect the peripheral nervous system, such as, but not only, diabetes mellitus, chronic heavy alcohol use, or toxic nerve lesions, or any polyneuropathy
- an additional injury that could compromise nerve regeneration
- clinically significant (as defined by the investigator) renal, hepatic, cardiac, endocrine, metabolic, hematologic, autoimmune, or any systemic disease, which may make implementation/interpretation of the protocol or results difficult
- previous conditions of the hand that could affect the healing of the actual nerve injury
- complete amputation injury
- extensive crush injury
Show all 15Show fewer
- grossly contaminated wound
- receiving immunosuppressive or antineoplastic agents within 30 days prior to the enrolment
- known to be HIV positive
- known pregnant and lactating females
- participated in another clinical investigation using an investigational new drug or device (or in the present study) within 30 days prior to enrolment into this investigation
- uncooperative or unsuitable, e.g. language problems or a suspicion to be unable to attend follow up appointments, for completion of the investigation
- absence of a healthy opposite finger
- suspected allergy to silk
- need of emergency surgery (within 24 hours from injury)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik für Plastische Chirurgie und Handchirurgie - UniversitätsSpital Zürich
Zurich, 8091
About this study
Official title: A Pilot Study to Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide
The goal of this study is to ascertain the feasibility and safety of the procedure using SilkBridge - a biocompatible silk fibroin-based scaffold - for the regeneration of sensory nerve fibres and follow it up together with the reinnervation of the target organs (sensory receptors in the skin).
Read the detailed description
This is a pre-market, monocentre, first-in-human pilot on adult patients with digital nerve defects. Category C clinical trial, medical devices. The study will be performed in Switzerland.
SilkBridge is a biocompatible silk fibroin-based scaffold, which recruits the patients' own cells to remodel or regenerate the nerve, without pre-seeding of the scaffold nor biological/chemical treatments.
SilkBridge will provide surgeons with an implant with unique features, such as easy suturability, full biocompatibility and specific biomimetic properties that enhance cells adhesion and integration of the device with the surrounding tissue.
The study will have a 12 months and 1 week duration per patient, including the follow-up period, and with an expected enrollment period of 15 months.
The study will evaluate 15 adult patients, aged 18-65 years, diagnosed with digital nerve defects (> 5 mm gap) in whom surgical repair may not allow direct suture.
- Being tested
- SilkBridge
- Keywords
- peripheral nerve injury, nerve guide, silk fibroin, silk, nerve regeneration
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilkBridgeDevice
SilkBridge is a biocompatible silk fibroin-based scaffold, which recruits the patients' own cells to remodel or regenerate the nerve, without pre-seeding of the scaffold nor biological/chemical treatments.
| Study group | Role | What they receive |
|---|---|---|
| SilkBridge treatment | Experimental | Surgery for digital nerve reconstruction with SilkBridge Receives: Device: SilkBridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of SilkBridge
Assess type and severity of adverse device effects related to SilkBridge and surgical procedure throughout the follow-up period
Measured: 12 months
Secondary outcomes (3)
Performance - assess at each study visit versus baseline
Sensory recovery after nerve reconstruction by static and moving 2-point discrimination and Semmes-Weinstein monofilament testing Pain evaluation via a visual analog scale (VAS: scale where patient has to specify level of pain by indicating a position along a continuous line between two end-points (0 - 10). 0 indicates no pain while 10 represents the highest level.)
Measured: 12 months
Performance - assess at V5 and at last visit versus opposite control finger
Sensory recovery by static and moving 2-point discrimination and Semmes-Weinstein monofilament testing
Measured: 6 and 12 months
Performance - assess at the last visit
Patient's satisfaction through the Patient Global Impression of Change (PGIC) questionnaire (Patient has to describe the change (if any) in activity limitations, symptoms, emotions and overall quality of life, in relation to its painful condition. 0 value represent no change, 7 a considerable improvement).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start22 Mar 2019
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Peripheral Nerve Injury Digital Nerve HandStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label Monocentre Study
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silk Biomaterials srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurizio Calcagni, MD, Principal investigator, Klinik für Plastische Chirurgie und Handchirurgie - UniversitätsSpital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673449
- Sponsor's protocol ID
- SB_DND-01/2018
- Status last verified
- Mar 2020
- First submitted
- 12 Sep 2018
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Faroni A, Mobasseri SA, Kingham PJ, Reid AJ. Peripheral nerve regeneration: experimental strategies and future perspectives. Adv Drug Deliv Rev. 2015 Mar;82-83:160-7. doi: 10.1016/j.addr.2014.11.010. Epub 2014 Nov 14.
PubMed 25446133Konofaos P, Ver Halen JP. Nerve repair by means of tubulization: past, present, future. J Reconstr Microsurg. 2013 Mar;29(3):149-64. doi: 10.1055/s-0032-1333316. Epub 2013 Jan 9.
PubMed 23303520Wieringa PA, Goncalves de Pinho AR, Micera S, van Wezel RJA, Moroni L. Biomimetic Architectures for Peripheral Nerve Repair: A Review of Biofabrication Strategies. Adv Healthc Mater. 2018 Apr;7(8):e1701164. doi: 10.1002/adhm.201701164. Epub 2018 Jan 19.
PubMed 29349931Ichihara S, Inada Y, Nakamura T. Artificial nerve tubes and their application for repair of peripheral nerve injury: an update of current concepts. Injury. 2008 Oct;39 Suppl 4:29-39. doi: 10.1016/j.injury.2008.08.029.
PubMed 18804584Pfister LA, Papaloizos M, Merkle HP, Gander B. Nerve conduits and growth factor delivery in peripheral nerve repair. J Peripher Nerv Syst. 2007 Jun;12(2):65-82. doi: 10.1111/j.1529-8027.2007.00125.x.
PubMed 17565531Daly W, Yao L, Zeugolis D, Windebank A, Pandit A. A biomaterials approach to peripheral nerve regeneration: bridging the peripheral nerve gap and enhancing functional recovery. J R Soc Interface. 2012 Feb 7;9(67):202-21. doi: 10.1098/rsif.2011.0438. Epub 2011 Nov 16.
PubMed 22090283Meek MF, Varejao AS, Geuna S. Use of skeletal muscle tissue in peripheral nerve repair: review of the literature. Tissue Eng. 2004 Jul-Aug;10(7-8):1027-36. doi: 10.1089/ten.2004.10.1027.
PubMed 15363160Vepari C, Kaplan DL. Silk as a Biomaterial. Prog Polym Sci. 2007;32(8-9):991-1007. doi: 10.1016/j.progpolymsci.2007.05.013.
PubMed 19543442Thurber AE, Omenetto FG, Kaplan DL. In vivo bioresponses to silk proteins. Biomaterials. 2015 Dec;71:145-157. doi: 10.1016/j.biomaterials.2015.08.039. Epub 2015 Aug 20.
PubMed 26322725De Vita R, Buccheri EM, Pozzi M, Zoccali G. Direct to implant breast reconstruction by using SERI, preliminary report. J Exp Clin Cancer Res. 2014 Nov 25;33(1):78. doi: 10.1186/s13046-014-0078-5.
PubMed 25422034Lee JH, Lee JS, Kim DK, Park CH, Lee HR. Clinical outcomes of silk patch in acute tympanic membrane perforation. Clin Exp Otorhinolaryngol. 2015 Jun;8(2):117-22. doi: 10.3342/ceo.2015.8.2.117. Epub 2015 May 13.
PubMed 26045909
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide
- ClinicalTrials.gov ID
- NCT03673449
- Acronym / sponsor ID
- SB_DND-01/2018
- Keywords
- peripheral nerve injury, nerve guide, silk fibroin, silk, nerve regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Silk Biomaterials srlIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 17 Sep 2018 (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.
The goal of this study is to ascertain the feasibility and safety of the procedure using SilkBridge - a biocompatible silk fibroin-based scaffold - for the regeneration of sensory nerve fibres and follow it up together with the reinnervation of the target organs (sensory receptors in the skin).
Detailed description
This is a pre-market, monocentre, first-in-human pilot on adult patients with digital nerve defects. Category C clinical trial, medical devices. The study will be performed in Switzerland.
SilkBridge is a biocompatible silk fibroin-based scaffold, which recruits the patients' own cells to remodel or regenerate the nerve, without pre-seeding of the scaffold nor biological/chemical treatments.
SilkBridge will provide surgeons with an implant with unique features, such as easy suturability, full biocompatibility and specific biomimetic properties that enhance cells adhesion and integration of the device with the surrounding tissue.
The study will have a 12 months and 1 week duration per patient, including the follow-up period, and with an expected enrollment period of 15 months.
The study will evaluate 15 adult patients, aged 18-65 years, diagnosed with digital nerve defects (> 5 mm gap) in whom surgical repair may not allow direct suture.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label Monocentre Study
| Arm | Type | Receives |
|---|---|---|
| SilkBridge treatment | Experimental | Device: SilkBridgeSurgery for digital nerve reconstruction with SilkBridge |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male \& female patients between 18 and 65 years of age
- a traumatic injury or a post-traumatic neuroma of a digital nerve on the palmar side of the hand, between the metacarpophalangeal joint and the distal interphalangeal joint
- single lesion per finger
- nerve defect of >5mm
- nerve treatment initiated within 24 months after nerve injury
Key exclusion criteria (15 listed)
- disorders known to affect the peripheral nervous system, such as, but not only, diabetes mellitus, chronic heavy alcohol use, or toxic nerve lesions, or any polyneuropathy
- an additional injury that could compromise nerve regeneration
- clinically significant (as defined by the investigator) renal, hepatic, cardiac, endocrine, metabolic, hematologic, autoimmune, or any systemic disease, which may make implementation/interpretation of the protocol or results difficult
- previous conditions of the hand that could affect the healing of the actual nerve injury
- complete amputation injury
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 |
|---|---|---|
| SilkBridgeSilkBridge is a biocompatible silk fibroin-based scaffold, which recruits the patients' own cells to remodel or regenerate the nerve, without pre-seeding of the scaffold nor biological/chemical treatments. | Device | SilkBridge treatment |
Primary outcome
Safety of SilkBridge
Time frame: 12 months
Assess type and severity of adverse device effects related to SilkBridge and surgical procedure throughout the follow-up period
3 secondary outcomes
Performance - assess at each study visit versus baseline
Time frame: 12 months
Performance - assess at V5 and at last visit versus opposite control finger
Time frame: 6 and 12 months
Performance - assess at the last visit
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Background: PubMed 25446133Faroni A, Mobasseri SA, Kingham PJ, Reid AJ. Peripheral nerve regeneration: experimental strategies and future perspectives. Adv Drug Deliv Rev. 2015 Mar;82-83:160-7. doi: 10.1016/j.addr.2014.11.010. Epub 2014 Nov 14.
- Background: PubMed 23303520Konofaos P, Ver Halen JP. Nerve repair by means of tubulization: past, present, future. J Reconstr Microsurg. 2013 Mar;29(3):149-64. doi: 10.1055/s-0032-1333316. Epub 2013 Jan 9.
- Background: PubMed 29349931Wieringa PA, Goncalves de Pinho AR, Micera S, van Wezel RJA, Moroni L. Biomimetic Architectures for Peripheral Nerve Repair: A Review of Biofabrication Strategies. Adv Healthc Mater. 2018 Apr;7(8):e1701164. doi: 10.1002/adhm.201701164. Epub 2018 Jan 19.
- Background: PubMed 18804584Ichihara S, Inada Y, Nakamura T. Artificial nerve tubes and their application for repair of peripheral nerve injury: an update of current concepts. Injury. 2008 Oct;39 Suppl 4:29-39. doi: 10.1016/j.injury.2008.08.029.
- Background: PubMed 17565531Pfister LA, Papaloizos M, Merkle HP, Gander B. Nerve conduits and growth factor delivery in peripheral nerve repair. J Peripher Nerv Syst. 2007 Jun;12(2):65-82. doi: 10.1111/j.1529-8027.2007.00125.x.
- Background: PubMed 22090283Daly W, Yao L, Zeugolis D, Windebank A, Pandit A. A biomaterials approach to peripheral nerve regeneration: bridging the peripheral nerve gap and enhancing functional recovery. J R Soc Interface. 2012 Feb 7;9(67):202-21. doi: 10.1098/rsif.2011.0438. Epub 2011 Nov 16.
- Background: PubMed 15363160Meek MF, Varejao AS, Geuna S. Use of skeletal muscle tissue in peripheral nerve repair: review of the literature. Tissue Eng. 2004 Jul-Aug;10(7-8):1027-36. doi: 10.1089/ten.2004.10.1027.
- Background: PubMed 19543442Vepari C, Kaplan DL. Silk as a Biomaterial. Prog Polym Sci. 2007;32(8-9):991-1007. doi: 10.1016/j.progpolymsci.2007.05.013.
- Background: PubMed 26322725Thurber AE, Omenetto FG, Kaplan DL. In vivo bioresponses to silk proteins. Biomaterials. 2015 Dec;71:145-157. doi: 10.1016/j.biomaterials.2015.08.039. Epub 2015 Aug 20.
- Background: PubMed 25422034De Vita R, Buccheri EM, Pozzi M, Zoccali G. Direct to implant breast reconstruction by using SERI, preliminary report. J Exp Clin Cancer Res. 2014 Nov 25;33(1):78. doi: 10.1186/s13046-014-0078-5.
- Background: PubMed 26045909Lee JH, Lee JS, Kim DK, Park CH, Lee HR. Clinical outcomes of silk patch in acute tympanic membrane perforation. Clin Exp Otorhinolaryngol. 2015 Jun;8(2):117-22. doi: 10.3342/ceo.2015.8.2.117. Epub 2015 May 13.
- Individual participant dataSharing planned: Undecided
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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.
Maurizio Calcagni, MD principal investigator
Klinik für Plastische Chirurgie und Handchirurgie - UniversitätsSpital Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SilkBridge in people with Peripheral Nerve Injury Digital Nerve Hand, run by Silk Biomaterials srl at 1 site in Switzerland.
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 6 inclusion and 15 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of SilkBridge (time frame: 12 months). 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 NCT03673449, which also lists 11 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 18 Mar 2020.