Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

  • STATUS
    Recruiting
  • End date
    Jun 26, 2022
  • participants needed
    20
  • sponsor
    Mayo Clinic
Updated on 26 January 2021
swelling
nerve biopsy
redness
sural
sural nerve biopsy

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.

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.

Details
Condition Peripheral Neuropathy, Amyloidosis, Amyloid, Chronic inflammatory demyelinating polyradiculoneuropathy, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Inherited Neuropathies, Vasculitic Neuropathy (Disorder), Hereditary Neuropathy, Sarcoid Neuropathy, peripheral nerve disease, peripheral nerve damage, Vasculitic Neuropathy (Disorder), Vasculitic Neuropathy (Disorder), Vasculitic Neuropathy (Disorder)
Treatment Biopsy + Nerve Repair, Biopsy Only
Clinical Study IdentifierNCT03584022
SponsorMayo Clinic
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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 (V)
Are able to comply with protocol requirements
Can provide written informed consent
Willingness to complete study procedures

Exclusion Criteria

Have systemic immune disorders, such as Crohn's Disease, rheumatoid arthritis, or psoriasis with the exception of hyper/hypothyroidism
Current smoker
Have diabetes mellitus
History of prior musculoskeletal (joint or soft tissue) infection
Have previous trauma to the biopsy site
Pre-operative nares culture positive for methicillin-resistant Staphylococcus Aureus (MRSA) or methicillin-sensitive Staphylococcus Aureus (MSSA)
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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