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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

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety as determined by number of participants with post-surgical reactions
Secondary study objectives
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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,324 Previous Clinical Trials
3,059,385 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
~5 spots leftby Mar 2027
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