New nerve patch could ease pain after biopsy

NCT ID NCT03584022

Symptom relief Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a biodegradable tube that is placed over a cut nerve during a leg biopsy. The goal is to see if it is safe and reduces common side effects like pain, redness, and swelling. Twenty adults with various nerve conditions are taking part, and half will get the tube while the other half will not.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: biodegradable nerve tube (poly(caprolactone-fumarate))
What this could lead to: If safe, this could lead to a way to reduce pain and swelling after nerve biopsies.
What could go wrong: This is a very small early safety study, so it may not show clear benefit. The device might not work better than standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2018

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

amyloidosis chronic inflammatory demyelinating polyradiculoneuropathy hereditary peripheral neuropathy peripheral nervous system disorder peripheral neuropathy sarcoid neuropathy vasculitic neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyloidosis Chronic inflammatory demyelinating polyradiculoneuropathy Hereditary neuropathy Peripheral neuropathy Sarcoid neuropathy Vasculitic neuropathy (disorder)

New nerve patch could ease pain after biopsy

What the study statuses mean