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Active, Not Recruiting

NCT Number: NCT03584022

Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Peripheral Neuropathy Amyloidosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Chronic Inflammatory Demyelinating Polyradiculoneuropathy Demyelinating Diseases Disease Attributes Hereditary Neuropathy Immune System Diseases Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Proteostasis Deficiencies Sarcoid Neuropathy Vasculitic Neuropathy (Disorder)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biopsy + Nerve Repair

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

Procedure

Standard sural nerve biopsy only, without nerve repair.

Primary outcomes

  1. Safety as determined by number of participants with post-surgical reactions

    Time frame: up to 5 years post surgery

    Post-surgical reactions will include evaluations of the following:

    • Percussion tenderness at site of proximal stump or repair site;
    • Skin redness at the site of biopsy (length and width measured with calipers);
    • 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.
    • Development of severe swelling or pustules or evidence of tube extrusion or wound dehiscence.

Secondary outcomes

  1. Neuropathic pain as measured by SNAP

    Time frame: 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.

  2. Neuropathic pain as measured by visual analogue pain scale

    Time frame: 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.

  3. Neuropathic pain as measured by visual analogue pain assessment questionnaire

    Time frame: 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

  4. Neuroma formation

    Time frame: 3 months & 12 months

    Non-invasive nerve ultrasound will be performed to determine neuroma formation

  5. Sensory nerve regeneration as measured by SNAP

    Time frame: 3 months & 12 months

    The amplitude of sensory nerve action potential (SNAP) will be used to determine sensory nerve regeneration

  6. Sensory nerve regeneration as measured by ultrasound

    Time frame: 3 months & 12 months

    Non-invasive nerve ultrasound will be performed to determine sensory nerve regeneration

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Jul 12, 2018
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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