Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-09

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Neuropathy Chronic Inflammatory Demyelinating Polyradiculoneuropathy Vasculitic Neuropathy (Disorder) Amyloidosis Hereditary Neuropathy Sarcoid Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Biopsy + Nerve Repair

Intervention Type DEVICE

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.

Biopsy Only

Subjects will undergo the same standard sural nerve biopsy procedure as the Experimental Group, but will not include the nerve repair.

Group Type SHAM_COMPARATOR

Biopsy Only

Intervention Type PROCEDURE

Standard sural nerve biopsy only, without nerve repair.

Interventions

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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.

Intervention Type DEVICE

Biopsy Only

Standard sural nerve biopsy only, without nerve repair.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No