Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Safety as determined by number of participants with post-surgical reactions [up to 12 months post surgery]
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 [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 [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 [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 [3 months & 12 months]
Non-invasive nerve ultrasound will be performed to determine neuroma formation
- Sensory nerve regeneration as measured by SNAP [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 [3 months & 12 months]
Non-invasive nerve ultrasound will be performed to determine sensory nerve regeneration
Eligibility Criteria
Criteria
Inclusion Criteria
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Are between the ages of 18-75 years
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Have clinical indications for whole sural nerve biopsy
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Have a sural nerve SNAP with amplitude > or = 2 microvolt (μV)
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Are able to comply with protocol requirements
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Can provide written informed consent
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Willingness to complete study procedures
Exclusion Criteria
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Current smoker.
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History of prior musculoskeletal (joint or soft tissue) infection.
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Pre-operative nares culture positive for methicillin-resistant Staphylococcus Aureus (MRSA) or methicillin-sensitive Staphylococcus Aureus (MSSA)
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Have systemic immune disorders, such as Crohn's Disease, rheumatoid arthritis, or psoriasis with the exception of hyper/hypothyroidism.
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Have diabetes mellitus.
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Have previous trauma to the biopsy site.
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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.
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Are pregnant or breast-feeding.
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Unwilling to use adequate contraception.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Anthony J Windebank, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 17-008763