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Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide

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ClinicalTrials.gov Identifier: NCT03673449
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Silk Biomaterials srl

Brief 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).

Condition or disease Intervention/treatment Phase
Peripheral Nerve Injury Digital Nerve Hand Device: SilkBridge Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open Label Monocentre Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide
Actual Study Start Date : March 22, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SilkBridge treatment
Surgery for digital nerve reconstruction with SilkBridge
Device: SilkBridge
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Performance - assess at each study visit versus baseline [ Time Frame: 12 months ]
    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.)

  2. Performance - assess at V5 and at last visit versus opposite control finger [ Time Frame: 6 and 12 months ]
    Sensory recovery by static and moving 2-point discrimination and Semmes-Weinstein monofilament testing

  3. Performance - assess at the last visit [ Time Frame: 12 months ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673449


Contacts
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Contact: Gabriele Grecchi +393921751186 gabriele@silkbiomaterials.com
Contact: Antonio Alessandrino +393389945118 antonio@silkbiomaterials.com

Locations
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Switzerland
Klinik für Plastische Chirurgie und Handchirurgie - UniversitätsSpital Zürich Recruiting
Zürich, Switzerland, 8091
Contact: Sabine Kern    +41442554600    Sabine.Kern@usz.ch   
Principal Investigator: Maurizio Calcagni, MD         
Sponsors and Collaborators
Silk Biomaterials srl
Investigators
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Principal Investigator: Maurizio Calcagni, MD Klinik für Plastische Chirurgie und Handchirurgie - UniversitätsSpital Zürich

Publications:

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Responsible Party: Silk Biomaterials srl
ClinicalTrials.gov Identifier: NCT03673449     History of Changes
Other Study ID Numbers: SB_DND-01/2018
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Silk Biomaterials srl:
peripheral nerve injury
nerve guide
silk fibroin
silk
nerve regeneration

Additional relevant MeSH terms:
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Peripheral Nerve Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries