Actively Recruiting
A Phase 2a Multicenter Randomized Controlled Trial Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion) Compared to Standard of Care in the Repair of Mixed Motor-sensory Acute Peripheral Nerve Injuries (PNI) for Rapid and Immediate Improvement in Outcome
Led by Major Extremity Trauma Research Consortium · Updated on 2026-02-27
40
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Major Extremity Trauma Research Consortium
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effects of polyethylene glycol (PEG) fusion in patients with acute upper extremity peripheral nerve injuries. This Phase 2a randomized controlled trial aims to compare PEG fusion combined with primary nerve repair or reconstruction to conventional nerve reconstruction. The study seeks to establish safety data and assess clinical outcomes such as recovery of sensory and motor function, range of motion, hand strength, disability, pain, and patient satisfaction over up to two years. The trial will enroll 40 patients who have sustained complete peripheral nerve injuries in the upper extremity within 48 hours. Participants will be randomly assigned to receive either PEG-mediated nerve reconstruction using NTX-001 applied topically via a surgical device or conventional nerve reconstruction without PEG. NTX-001 is used as an adjunct during nerve repair surgery to promote axonal membrane fusion. The study hypothesizes that PEG fusion will have comparable short-term complication rates and may lead to earlier and improved functional recovery compared to standard surgery. Participants will be monitored for complications within the first 30 days and followed for up to two years to evaluate nerve regeneration and functional outcomes. Assessments include sensory and motor function recovery, range of motion, hand strength, pain levels, disability, and treatment satisfaction. The trial involves regular clinical evaluations to track progress and safety, with data also compared to an external prospective study for validation. Total participation duration spans up to two years post-surgery.
CONDITIONS
Brief Title
Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 80 years
- Sustained a complete peripheral nerve injury from upper extremity trauma within 48 hours
- Injury involves motor and/or sensory function of axillary, radial, median, ulnar, or musculocutaneous nerves between the proximal humerus and wrist crease
- Injury involves a mixed nerve segment containing both sensory and motor axons
You will not qualify if you...
- Surgery beginning within hours after injury
- Injury to brachial plexus nerves
- Injury distal to the wrist crease
- Injury involving sensory-only distal nerve extensions or specific motor branches distal to the forearm midpoint
- Previous peripheral nerve injury from trauma, stroke, or neurologic disorders
- Documented psychiatric disorder likely to cause self-harm or interfere with follow-up
- Severe problems maintaining follow-up (e.g., prisoners, homeless without support)
- Not expected to survive 30 days due to injuries or health
- Known allergy to polyethylene glycol (PEG)
- Inability to perform required assessments on the contralateral side or abnormal baseline sensory values
- Pregnant or breastfeeding
- Significant medical conditions preventing immediate repair
- Inability to adhere strictly to the clinical protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Surgery within 24 hours of injury
Participants receive either PEG mediated nerve reconstruction using NTX-001 applied topically during surgery or conventional nerve reconstruction.
1 surgical visit (in-person)
Duration - Up to 2 years
Participants are monitored for complications within the first 30 days and for nerve regeneration and functional recovery over 2 years.
Multiple follow-up visits over 2 years
Trial Site Locations
Total: 7 locations
1
University of Maryland Medical Center Shock Trauma Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
2
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21213
Actively Recruiting
3
Cooper Health
Camden, New Jersey, United States, 08103
Actively Recruiting
4
OrthoCarolina
Charlotte, North Carolina, United States, 28207
Actively Recruiting
5
Wellspan Health
York, Pennsylvania, United States, 17403
Actively Recruiting
6
San Antonio Military Medical Center (SAMMC)
San Antonio, Texas, United States, 78234
Actively Recruiting
7
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23219
Actively Recruiting
Research Team
E
Elizabeth Wysocki, MA
A
Ala Elhelali, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here