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Scaffold Biomaterial

Scaffold Biomaterial for Neuropathy

N/A

Waitlist Available

Led By Anthony J Windebank, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have clinical indications for whole sural nerve biopsy

Are between the ages of 18-75 years

Must not have

History of prior musculoskeletal (joint or soft tissue) infection

Have diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post surgery

Awards & highlights

Summary

This trial is testing whether it is safe to do nerve surgery with or without grafting.

Who is the study for?

This trial is for adults aged 18-75 with certain nerve conditions who need a sural nerve biopsy and can follow the study plan. They must have a specific level of nerve signal strength, not smoke, and not be pregnant or breastfeeding. People with recent major heart issues, immune disorders (except thyroid conditions), previous trauma at the biopsy site, or infections like MRSA are excluded.

What is being tested?

The study is testing the safety of a new biomaterial used in repairing nerves after a biopsy compared to no repair. Participants will either receive this novel scaffold biomaterial during their routine surgery or just undergo the biopsy without any nerve repair.

What are the potential side effects?

After surgery, patients might experience swelling, redness, tenderness at the surgical site and dysesthesia—a kind of abnormal sensation like prickling. The side effects related to grafting versus non-grafting will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need a biopsy of my sural nerve.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an infection in my joints or soft tissues before.

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I have diabetes.

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I tested positive for MRSA or MSSA in a nose culture.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Neuroma formation

Neuropathic pain as measured by SNAP

Neuropathic pain as measured by visual analogue pain assessment questionnaire

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Biopsy + Nerve RepairExperimental Treatment1 Intervention

Subjects will undergo standard sural nerve biopsy plus repair of the 6 cm nerve defect using a synthetic polymer (PCLF) nerve tube.

Group II: Biopsy OnlyPlacebo Group1 Intervention

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,255 Previous Clinical Trials

3,835,386 Total Patients Enrolled

5 Trials studying Peripheral Neuropathy

334 Patients Enrolled for Peripheral Neuropathy

Anthony J Windebank, MDPrincipal InvestigatorMayo Clinic

1 Previous Clinical Trials

75 Total Patients Enrolled

Media Library

Biopsy + Nerve Repair (Scaffold Biomaterial) Clinical Trial Eligibility Overview. Trial Name: NCT03584022 — N/A

Peripheral Neuropathy Research Study Groups: Biopsy + Nerve Repair, Biopsy Only

Peripheral Neuropathy Clinical Trial 2023: Biopsy + Nerve Repair Highlights & Side Effects. Trial Name: NCT03584022 — N/A

Biopsy + Nerve Repair (Scaffold Biomaterial) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03584022 — N/A

Peripheral Neuropathy Patient Testimony for trial: Trial Name: NCT03584022 — N/A

~6 spots leftby Mar 2027

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