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Polyethylene Glycol for Nerve Injury
Phase 1
Waitlist Available
Led By Richard C Trevino, MD
Research Sponsored by WellSpan Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Class III nerve injury (Sunderland's 4th or 5th degree injury).
Must not have
Injuries beyond 24 hours will be excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if PEG 3350 is safe and effective for repairing nerves.
Who is the study for?
This trial is for individuals with specific nerve injuries in their fingers, forearm, wrist, or palm. These should be fresh injuries (within 24 hours) and classified as severe (Sunderland's 4th or 5th degree). The injury must be repairable without too much tension at the surgeon's discretion. Pregnant or breastfeeding women are not eligible.
What is being tested?
The study is testing the safety and effectiveness of a substance called PEG 3350 when used to repair severely damaged nerves. It aims to see if this treatment can improve outcomes by converting more serious nerve damage to less severe forms.
What are the potential side effects?
While the side effects of PEG 3350 in nerve repair aren't detailed here, common reactions might include local irritation at the site of application, allergic reactions, or no improvement in nerve function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a severe nerve injury.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My injury occurred within the last 24 hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nerve injury to palm and fingersExperimental Treatment1 Intervention
Adult patients with acute clean nerve transections of the higher arm injuries in the forearm, wrist, palm and digits of the hand will be recruited
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polyethylene Glycols
2015
Completed Phase 4
~1650
Find a Location
Who is running the clinical trial?
WellSpan HealthLead Sponsor
30 Previous Clinical Trials
2,004,850 Total Patients Enrolled
Neuraptive Therapeutics Inc.Industry Sponsor
4 Previous Clinical Trials
151 Total Patients Enrolled
Richard C Trevino, MDPrincipal InvestigatorWellSpan York Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a severe nerve injury.My nerve injury can be fixed with little to acceptable tension, as per my surgeon.My injury occurred within the last 24 hours.I have a cut nerve in my fingers, forearm, wrist, or palm.
Research Study Groups:
This trial has the following groups:- Group 1: Nerve injury to palm and fingers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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