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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biopsy + Nerve Repair | Experimental | Subjects will undergo standard sural nerve biopsy plus repair of the 6 cm nerve defect using a synthetic polymer (PCLF) nerve tube. |
|
| Biopsy Only | Sham Comparator | Subjects will undergo the same standard sural nerve biopsy procedure as the Experimental Group, but will not include the nerve repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy + Nerve Repair | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as determined by number of participants with post-surgical reactions | Post-surgical reactions will include evaluations of the following:
| up to 5 years post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months & 12 months |
| Neuropathic pain as measured by visual analogue pain scale |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Anthony J Windebank, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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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.
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|
| Biopsy Only | Procedure | Standard sural nerve biopsy only, without nerve repair. |
|
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. |
| weekly, monthly for first 3 months, then 12 months and yearly for 4 years |
| 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 | weekly, monthly for first 3 months, then 12 months and yearly for 4 years |
| Neuroma formation | Non-invasive nerve ultrasound will be performed to determine neuroma formation | 3 months & 12 months |
| Sensory nerve regeneration as measured by SNAP | The amplitude of sensory nerve action potential (SNAP) will be used to determine sensory nerve regeneration | 3 months & 12 months |
| Sensory nerve regeneration as measured by ultrasound | Non-invasive nerve ultrasound will be performed to determine sensory nerve regeneration | 3 months & 12 months |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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