Clinical trial NCT03584022: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Neuropathy
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Vasculitic Neuropathy (Disorder)
Amyloidosis
Hereditary Neuropathy
Sarcoid Neuropathy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Safety as determined by number of participants with post-surgical reactions
timeFrame: up to 5 years post surgery
Secondary outcomes:
measure: Neuropathic pain as measured by SNAP
timeFrame: 3 months & 12 months
measure: Neuropathic pain as measured by visual analogue pain scale
timeFrame: weekly, monthly for first 3 months, then 12 months and yearly for 4 years
measure: Neuropathic pain as measured by visual analogue pain assessment questionnaire
timeFrame: weekly, monthly for first 3 months, then 12 months and yearly for 4 years
measure: Neuroma formation
timeFrame: 3 months & 12 months
measure: Sensory nerve regeneration as measured by SNAP
timeFrame: 3 months & 12 months
measure: Sensory nerve regeneration as measured by ultrasound
timeFrame: 3 months & 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Anthony J Windebank, MD
role: PRINCIPAL_INVESTIGATOR
References: