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Peripheral NeuropathyNCT03584022

Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

A study testing Biopsy + Nerve Repair and Biopsy Only in people with Peripheral Neuropathy and Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by Mayo Clinic at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Biopsy + Nerve Repair and Biopsy Only
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
9 Nov 2018to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A 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.

Read the 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.

Being tested
Biopsy + Nerve Repair, Biopsy Only
Medical subject headings
Peripheral Nervous System Diseases, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy + Nerve RepairDevice

    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 OnlyProcedure or surgery

    Standard sural nerve biopsy only, without nerve repair.

Study groups in NCT03584022
Study groupRoleWhat they receive
Biopsy + Nerve RepairExperimentalSubjects will undergo standard sural nerve biopsy plus repair of the 6 cm nerve defect using a synthetic polymer (PCLF) nerve tube.
Receives: Device: Biopsy + Nerve Repair
Biopsy OnlySham comparatorSubjects will undergo the same standard sural nerve biopsy procedure as the Experimental Group, but will not include the nerve repair.
Receives: Procedure: Biopsy Only

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Post-surgical reactions will include evaluations of the following:

    1. Percussion tenderness at site of proximal stump or repair site;
    2. Skin redness at the site of biopsy (length and width measured with calipers);
    3. 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.
    4. Development of severe swelling or pustules or evidence of tube extrusion or wound dehiscence.

    Measured: up to 5 years post surgery

Secondary outcomes (6)

  1. Neuropathic pain as measured by SNAP

    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.

    Measured: 3 months & 12 months

  2. Neuropathic pain as measured by visual analogue pain scale

    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.

    Measured: weekly, monthly for first 3 months, then 12 months and yearly for 4 years

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

    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

    Measured: weekly, monthly for first 3 months, then 12 months and yearly for 4 years

  4. Neuroma formation

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

    Measured: 3 months & 12 months

  5. Sensory nerve regeneration as measured by SNAP

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

    Measured: 3 months & 12 months

  6. Sensory nerve regeneration as measured by ultrasound

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

    Measured: 3 months & 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2018
  2. Study start9 Nov 2018
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03584022
Sponsor's protocol ID
17-008763
Status last verified
Apr 2026
First submitted
11 May 2018
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Biopsy + Nerve Repair and Biopsy Only in people with Peripheral Neuropathy and Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety as determined by number of participants with post-surgical reactions (time frame: up to 5 years post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03584022.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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