Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Amyloidosis
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Hereditary Neuropathy
Peripheral Nervous System Diseases
Peripheral Neuropathy
Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Sarcoid Neuropathy
Vasculitic Neuropathy (Disorder)

Clinical Trial Details

NCT number	NCT03584022
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Active, not recruiting
Phase	N/A
Start date	November 9, 2018
Completion date	March 2027

View Details

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