Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03584022
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Anthony J. Windebank, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE May 11, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date December 10, 2019
Actual Study Start Date  ICMJE November 9, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
Safety as determined by number of participants with post-surgical reactions [ Time Frame: up to 12 months post surgery ]
Post-surgical reactions will include evaluations of the following:
  1. Percussion tenderness at site of proximal stump or repair site;
  2. Skin redness at the site of biopsy (length and width measured with calipers);
  3. Development of mild or moderate swelling along the site (yes or no). It is anticipated that this will resolve to a lower grade or progress to grade 4.
  4. Development of severe swelling or pustules or evidence of tube extrusion or wound dehiscence.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • Neuropathic pain as measured by SNAP [ Time Frame: 3 months & 12 months ]
    Sensory nerve action potential (SNAP) will be measured at the ankle using small electric shocks and recording pads on the skin. This will be done by an experienced and board-certified electrophysiologist.
  • Neuropathic pain as measured by visual analogue pain scale [ Time Frame: weekly, monthly for first 3 months, then 12 months ]
    The Visual Analogue Scale (VAS) consists of a straight line with the endpoints of 'No pain' and 'Pain as bad as it could possibly be'. The subject is asked to mark his or her pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark defines the subject's pain.
  • Neuropathic pain as measured by visual analogue pain assessment questionnaire [ Time Frame: weekly, monthly for first 3 months, then 12 months ]
    Subjects will be asked to check all of the following that apply: 1) fever, 2) unexplained or new joint aches and pain, 3) increased skin redness at or near the site of the biopsy, 4) increased swelling at or near the site of the biopsy, 5) some degree of pain or discomfort at or near the site of the biopsy
  • Neuroma formation [ Time Frame: 3 months & 12 months ]
    Non-invasive nerve ultrasound will be performed to determine neuroma formation
  • Sensory nerve regeneration as measured by SNAP [ Time Frame: 3 months & 12 months ]
    The amplitude of sensory nerve action potential (SNAP) will be used to determine sensory nerve regeneration
  • Sensory nerve regeneration as measured by ultrasound [ Time Frame: 3 months & 12 months ]
    Non-invasive nerve ultrasound will be performed to determine sensory nerve regeneration
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
Official Title  ICMJE A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
Brief Summary This is safety study. Subjects will be undergoing the surgical procedure of nerve biopsy. After routine surgery without grafting, patients develop swelling, redness, tenderness and dysesthesia at the biopsy site. In order to determine whether grafting is safe compared to not repairing the nerve, it is necessary to compare treated vs. untreated patients using systematic, sensitive and reproducible criteria.
Detailed Description

Patients will be evaluated for eligibility and then, after gaining informed consent, the surgical procedure will be scheduled. Baseline evaluations include physical/neurological examination, nerve conduction study and ultrasonography of the sural nerve, and testing for erythrocyte sedimentation rate, C-reactive protein and complete blood counts (with white blood cell differential). Surgery is done in an operating room under local or monitored anesthesia, depending on patient preference. An incision will be made above the ankle. Immediately after the surgery, the patient will repeat the baseline physical/neurological exams, and sural nerve ultrasonography.

Participants will be evaluated either in the clinic or by phone on a regular basis and will be required to keep a journal and fill out symptom questionnaires for up to 12 months post-procedure.

Development of a grade 4 local reaction at any time will fulfill criteria for review by the Data and Safety Monitoring Board (DSMB) for implant removal and definition as a failure.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients planned for diagnostic sural nerve biopsy will be screened. Nerve conduction study of the sural nerve is part of standard of care for patients who are screened for the study. If the amplitude of sensory nerve action potential (SNAP) is equal to or greater than 2 μV and the patient meets the other inclusive criteria, the patient will be recruited to enter the study. Ultrasonography of the sural nerve will be conducted. If the diameter of the sural nerve is greater than 2.75mm, the patient will be assigned to the control group. If sural nerve diameter is equal to or smaller than 2.75mm, the patient will be randomized to either the control or study group. A study team member (clinical coordinator) will draw a number from an envelope that holds equal amount of odd and even numbers. If the number drawn is an odd number, the patient will be assigned to the control group. If the number drawn is an even number, the patient will be assigned to the intervention group.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Peripheral Neuropathy
  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy
  • Vasculitic Neuropathy (Disorder)
  • Amyloidosis
  • Hereditary Neuropathy
  • Sarcoid Neuropathy
Intervention  ICMJE
  • Device: Biopsy + Nerve Repair
    During the standard sural nerve biopsy procedure, a single-use, biodegradable implant designed to repair damaged peripheral nerves will be used to repair the nerve. The MCNS1 is a hollow nerve tube made of poly(caprolactone-fumarate) (PCLF), to connect severed nerve ends and promote the growth of regenerating axons.
  • Procedure: Biopsy Only
    Standard sural nerve biopsy only, without nerve repair.
Study Arms  ICMJE
  • Experimental: Biopsy + Nerve Repair
    Subjects will undergo standard sural nerve biopsy plus repair of the 6 cm nerve defect using a synthetic polymer (PCLF) nerve tube.
    Intervention: Device: Biopsy + Nerve Repair
  • Sham Comparator: Biopsy Only
    Subjects will undergo the same standard sural nerve biopsy procedure as the Experimental Group, but will not include the nerve repair.
    Intervention: Procedure: Biopsy Only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Are between the ages of 18-75 years
  • Have clinical indications for whole sural nerve biopsy
  • Have a sural nerve SNAP with amplitude > or = 2 microvolt (μV)
  • Are able to comply with protocol requirements
  • Can provide written informed consent
  • Willingness to complete study procedures

Exclusion Criteria

  • Have systemic immune disorders, such as Crohn's Disease, rheumatoid arthritis, or psoriasis with the exception of hyper/hypothyroidism.
  • Have diabetes mellitus.
  • Have previous trauma to the biopsy site.
  • Have any major, clinically significant medical condition (e.g., within six months of baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure) that, in the opinion of the investigator, would compromise the safety of patient.
  • Are pregnant or breast-feeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michelle Turner 507-284-1223 Turner.Michelle@mayo.edu
Contact: Jane Sultze 507-538-5523 Sultze.Jane@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584022
Other Study ID Numbers  ICMJE 17-008763
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anthony J. Windebank, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anthony J Windebank, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP