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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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

PEG 3350 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03236064 — Phase 1
Wrist and Hand Injury Research Study Groups: Nerve injury to palm and fingers
Wrist and Hand Injury Clinical Trial 2023: PEG 3350 Highlights & Side Effects. Trial Name: NCT03236064 — Phase 1
PEG 3350 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03236064 — Phase 1
~1 spots leftby Oct 2025
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