Evaluating PEG Fusion for Peripheral Nerve Injuries

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

This study is testing if a new method using polyethylene glycol can help people with recent nerve injuries in their arms heal better than the standard treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Major Extremity Trauma Research Consortium (other)
• Locations: 7 sites (Baltimore, Maryland and 6 other locations)
• Trial ID: NCT04789044 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of polyethylene glycol (PEG) mediated fusion in patients with acute upper extremity peripheral nerve injuries. It will enroll 40 patients who will be randomized to receive either PEG mediated reconstruction or conventional nerve reconstruction within 24 hours of their injury. The study will monitor complications, nerve regeneration, and recovery of sensory and motor function over a period of two years. The results will be validated against data from the DoD funded NERVE study to inform future larger efficacy trials.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who have sustained a complete peripheral nerve injury from upper extremity trauma within 48 hours.

Not a fit: Patients with injuries to the brachial plexus or those whose injuries are distal to the wrist may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved recovery outcomes for patients with peripheral nerve injuries.

How similar studies have performed: While PEG has been used in other medical applications, its use for nerve regeneration in humans is novel and has not been rigorously tested.

Eligibility criteria

Inclusion Criteria:

1. Ages 18-80
2. Sustained a complete peripheral nerve injury resulting from upper extremity trauma presenting within 48 hours of injury
3. Involves injury or dysfunction to motor and/or sensory function of the axillary, radial, median, ulnar, or musculocutaneous nerve with injury localized between the proximal humerus and the distal flexion crease of the wrist
4. Involves a "mixed" nerve segment (i.e., involves a location of any of the above specified nerves that can be expected to have both sensory and motor axons present).

Exclusion Criteria:

1. Patients beginning surgery within hours after injury.
2. Injury to the brachial plexus nerves
3. Injury to the nerves distal to the distal flexion crease of the wrist
4. Injury that involves a distal extension of the parent nerve that is considered sensory only (superficial radial nerve, lateral antebrachial cutaneous nerve, etc.) or the posterior interosseus or anterior interosseus nerve distal to the midpoint of the forearm (i.e., distal to what can be considered the main motor branches of the PIN and AIN).
5. Previous peripheral nerve injury resulting from trauma, stroke, muscular, neurologic, or neuromuscular disorder
6. Documented psychiatric disorder that is expected to result in high probability of self-harm or interfere with study follow-up.
7. Severe problems with maintaining follow up (e.g., patients who are prisoners or homeless at time of injury or who are intellectually challenged without adequate family support).
8. Not expected to survive the next 30 days due to their injuries/health condition.
9. The subject has a known allergy to polyethylene glycol (PEG).
10. If any of the assessments cannot be done on the contralateral side (CL) or the MRCC sensory 2PD value is \> 10 mm on the CL side during baseline period, the subject is a screen failure.
11. The subject is pregnant and/or is breastfeeding.
12. The subject has a significant medical comorbidity precluding immediate repair.
13. The subject is not able to strictly adhere to the rules of the current clinical protocol.

Where this trial is running

Baltimore, Maryland and 6 other locations

• University of Maryland Medical Center Shock Trauma Center — Baltimore, Maryland, United States (RECRUITING)
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (RECRUITING)
• Cooper Health — Camden, New Jersey, United States (RECRUITING)
• OrthoCarolina — Charlotte, North Carolina, United States (RECRUITING)
• Wellspan Health — York, Pennsylvania, United States (RECRUITING)
• San Antonio Military Medical Center (SAMMC) — San Antonio, Texas, United States (RECRUITING)
• Virginia Commonwealth University Medical Center — Richmond, Virginia, United States (RECRUITING)

Study contacts

• Principal investigator: Ala Elhelali, PhD — Johns Hopkins University
• Study coordinator: Elizabeth Wysocki, MA

Conditions: Peripheral Nerve Injuries