Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
- Conditions
- Peripheral NeuropathySarcoid NeuropathyChronic Inflammatory Demyelinating PolyradiculoneuropathyAmyloidosisVasculitic Neuropathy (Disorder)Hereditary Neuropathy
- Interventions
- Procedure: Biopsy OnlyDevice: Biopsy + Nerve Repair
- Registration Number
- NCT03584022
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Biopsy Only Biopsy Only Subjects will undergo the same standard sural nerve biopsy procedure as the Experimental Group, but will not include the nerve repair. Biopsy + Nerve Repair 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.
- Primary Outcome Measures
Name Time Method Safety as determined by number of participants with post-surgical reactions up to 5 years 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
Name Time Method Neuroma formation 3 months & 12 months Non-invasive nerve ultrasound will be performed to determine neuroma formation
Neuropathic pain as measured by visual analogue pain scale weekly, monthly for first 3 months, then 12 months and yearly for 4 years 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 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.
Sensory nerve regeneration as measured by ultrasound 3 months & 12 months Non-invasive nerve ultrasound will be performed to determine sensory nerve regeneration
Neuropathic pain as measured by visual analogue pain assessment questionnaire weekly, monthly for first 3 months, then 12 months and yearly for 4 years 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
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
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States