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Trial record 49 of 49 for:    Polyneuropathies | CIDP

Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

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ClinicalTrials.gov Identifier: NCT03584022
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Anthony J. Windebank, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Chronic Inflammatory Demyelinating Polyradiculoneuropathy Vasculitic Neuropathy (Disorder) Amyloidosis Hereditary Neuropathy Sarcoid Neuropathy Device: Biopsy + Nerve Repair Procedure: Biopsy Only Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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.
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.

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.
Procedure: Biopsy Only
Standard sural nerve biopsy only, without nerve repair.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. Neuroma formation [ Time Frame: 3 months & 12 months ]
    Non-invasive nerve ultrasound will be performed to determine neuroma formation

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03584022


Contacts
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Contact: Michelle Turner 507-284-1223 Turner.Michelle@mayo.edu
Contact: Jane Sultze 507-538-5523 Sultze.Jane@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Anthony J Windebank, MD Mayo Clinic

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Responsible Party: Anthony J. Windebank, Professor of Neurology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03584022     History of Changes
Other Study ID Numbers: 17-008763
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Polyneuropathies
Peripheral Nervous System Diseases
Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Amyloidosis
Neuromuscular Diseases
Nervous System Diseases
Proteostasis Deficiencies
Metabolic Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases