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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 belowSelect...
I need a biopsy of my sural nerve.
Select...
I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had an infection in my joints or soft tissues before.
Select...
I have diabetes.
Select...
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
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 moreTrial 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
3,255 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an infection in my joints or soft tissues before.I have an immune disorder like Crohn's, rheumatoid arthritis, or psoriasis, but not thyroid issues.I need a biopsy of my sural nerve.You have had an injury at the place where a tissue sample was taken before.You are currently smoking cigarettes.I have diabetes.Your sural nerve SNAP has an amplitude of 2 microvolts or more.I tested positive for MRSA or MSSA in a nose culture.I am between 18 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Biopsy + Nerve Repair
- Group 2: Biopsy Only
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Peripheral Neuropathy Patient Testimony for trial: Trial Name: NCT03584022 — N/A
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