Back to resultsClinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
Primary Purpose
Peripheral Neuropathy, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Vasculitic Neuropathy (Disorder)
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biopsy + Nerve Repair
Biopsy Only
Sponsored by
About this trial
This is an interventional other trial for Peripheral Neuropathy
Eligibility 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
- Current smoker.
- History of prior musculoskeletal (joint or soft tissue) infection.
- Pre-operative nares culture positive for methicillin-resistant Staphylococcus Aureus (MRSA) or methicillin-sensitive Staphylococcus Aureus (MSSA)
- 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.
- Unwilling to use adequate contraception.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Biopsy + Nerve Repair
Biopsy Only
Arm Description
Subjects will undergo standard sural nerve biopsy plus repair of the 6 cm nerve defect using a synthetic polymer (PCLF) nerve tube.
Subjects will undergo the same standard sural nerve biopsy procedure as the Experimental Group, but will not include the nerve repair.
Outcomes
Primary Outcome Measures
Safety as determined by number of participants with post-surgical reactions
Post-surgical reactions will include evaluations of the following:
Percussion tenderness at site of proximal stump or repair site;
Skin redness at the site of biopsy (length and width measured with calipers);
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.
Development of severe swelling or pustules or evidence of tube extrusion or wound dehiscence.
Secondary Outcome Measures
Neuropathic pain as measured by SNAP
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
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
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
Non-invasive nerve ultrasound will be performed to determine neuroma formation
Sensory nerve regeneration as measured by SNAP
The amplitude of sensory nerve action potential (SNAP) will be used to determine sensory nerve regeneration
Sensory nerve regeneration as measured by ultrasound
Non-invasive nerve ultrasound will be performed to determine sensory nerve regeneration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03584022
Brief Title
Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
Official Title
A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Vasculitic Neuropathy (Disorder), Amyloidosis, Hereditary Neuropathy, Sarcoid Neuropathy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biopsy + Nerve Repair
Arm Type
Experimental
Arm Description
Subjects will undergo standard sural nerve biopsy plus repair of the 6 cm nerve defect using a synthetic polymer (PCLF) nerve tube.
Arm Title
Biopsy Only
Arm Type
Sham Comparator
Arm Description
Subjects will undergo the same standard sural nerve biopsy procedure as the Experimental Group, but will not include the nerve repair.
Intervention Type
Device
Intervention Name(s)
Biopsy + Nerve Repair
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Biopsy Only
Intervention Description
Standard sural nerve biopsy only, without nerve repair.
Primary Outcome Measure Information:
Title
Safety as determined by number of participants with post-surgical reactions
Description
Post-surgical reactions will include evaluations of the following:
Percussion tenderness at site of proximal stump or repair site;
Skin redness at the site of biopsy (length and width measured with calipers);
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.
Development of severe swelling or pustules or evidence of tube extrusion or wound dehiscence.
Time Frame
up to 5 years post surgery
Secondary Outcome Measure Information:
Title
Neuropathic pain as measured by SNAP
Description
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.
Time Frame
3 months & 12 months
Title
Neuropathic pain as measured by visual analogue pain scale
Description
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.
Time Frame
weekly, monthly for first 3 months, then 12 months and yearly for 4 years
Title
Neuropathic pain as measured by visual analogue pain assessment questionnaire
Description
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
Time Frame
weekly, monthly for first 3 months, then 12 months and yearly for 4 years
Title
Neuroma formation
Description
Non-invasive nerve ultrasound will be performed to determine neuroma formation
Time Frame
3 months & 12 months
Title
Sensory nerve regeneration as measured by SNAP
Description
The amplitude of sensory nerve action potential (SNAP) will be used to determine sensory nerve regeneration
Time Frame
3 months & 12 months
Title
Sensory nerve regeneration as measured by ultrasound
Description
Non-invasive nerve ultrasound will be performed to determine sensory nerve regeneration
Time Frame
3 months & 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Current smoker.
History of prior musculoskeletal (joint or soft tissue) infection.
Pre-operative nares culture positive for methicillin-resistant Staphylococcus Aureus (MRSA) or methicillin-sensitive Staphylococcus Aureus (MSSA)
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.
Unwilling to use adequate contraception.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony J Windebank, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
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