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Polyethylene Glycol for Nerve Injury

Phase 1
Recruiting
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).
Nerve injuries that can be prepared using minimal or acceptable tension (according to surgeon discretion).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
My nerve injury can be fixed with little to acceptable tension, as per my surgeon.
Select...
I have a cut nerve in my fingers, forearm, wrist, or palm.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques

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
28 Previous Clinical Trials
2,004,628 Total Patients Enrolled
Neuraptive Therapeutics Inc.Industry Sponsor
3 Previous Clinical Trials
53 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current sample size of this trial's participants?

"Affirmative. Clinicaltrials.gov indicates that this investigation is currently recruiting participants, having first been created on May 1st 2016 and its details most recently updated in January 2021. The study seeks to admit 10 volunteers at a single centre."

Answered by AI

Are there any available openings to join this medical experiment?

"Affirmative, the clinicaltrials.gov listing proves that this trial is still in search of volunteers. The study was initially advertised on May 1st 2016 and revised just recently on January 22nd 2021. It requires 10 participants from one medical site."

Answered by AI

Has the Food and Drug Administration sanctioned Polyethylene Glycols?

"Due to the limited safety data and efficacy evidence, Polyethylene Glycols is given a score of 1."

Answered by AI

Is the age minimum for this trial 18 years and above?

"This trial abides by an age range which begins at 16 and concludes at 65, thus satisfying the inclusion criteria."

Answered by AI

What is the eligibility criteria to participate in this trial?

"This clinical trial necessitates 10 test subjects who are between 16 and 65 years old, with current wounds. In addition to this criterion, prospective participants must not be pregnant or breastfeeding due to possible risks posed to the fetus. Isolated nerve transections of digits, forearm, wrist and palm within a Sunderland's 4th or 5th degree injury score fall into the scope of inclusion. The study will also accept cases where minimal tension can be used during preparation that occur in less than 24 hours; beyond that window is excluded from consideration."

Answered by AI
~0 spots leftby May 2024