Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

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.

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.