Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)

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

The overall objective of this study is to determine the safety of PEG fusion when used with primary repair or reconstruction in patients with an acute upper extremity peripheral nerve injury. PEG is safe and effective for extending the half-life of circulating pharmaceutical products, when used in conjunction with a topical hemostatic agent in surgical wounds, and when used as a colon cleanser for endoscopic surgical procedures. However, PEG fusion has not been rigorously tested as a safe reagent to promote nerve regeneration in humans. Therefore, the goal of this Phase 2a clinical trial is to establish safety data and to examine the effect of PEG fusion on clinical outcomes including recovery of sensory and motor function. Results will be externally validated using data collected in the DoD funded prospective NERVE study and will provide preliminary evidence to power a larger phase II efficacy trial.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Nerve Injuries
• Intervention / Treatment: Drug: NTX-001

Detailed Description

The study will enroll 40 patients receiving autograft reconstruction within 24 hours of injury. Patients will be randomized to either PEG mediated reconstruction (n=20); or conventional nerve reconstruction (n=20). The investigators hypothesize that (1) the rate of complications within 1 month of surgery in patients treated with PEG fusion will be comparable to that of patients treated with conventional autograft reconstruction, (2) there will be no detrimental effects from PEG fusion on nerve regeneration over 2 years compared to patients treated with conventional nerve reconstruction, ((3) recovery of sensory and motor function will occur earlier (within 6 months) among patients treated with PEG fusion compared to patients treated with conventional autograft reconstruction (4) patients treated with PEG fusion will have better range of motion, greater hand strength, less disability, less pain, and higher rates of treatment satisfaction compared with patients treated with conventional autograft reconstruction.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Elizabeth Wysocki, MA; Phone Number: 410-955-0396; Email: ewysock2@jhu.edu
• Study Contact Backup: Name: Ala Elhelali, PhD; Phone Number: 443-220-2537; Email: aelhela1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21213
      • Recruiting
      • Johns Hopkins University School of Medicine
      • Principal Investigator: Jaimie Shores, MD
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland Medical Center Shock Trauma Center
      • Principal Investigator: Ray Pensy, MD
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Cooper Health
      • Contact: Pietro Gentile
      • Contact: Email: gentile-pietro@CooperHealth.edu
      • Principal Investigator: David Fuller, MD
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • OrthoCarolina
      • Principal Investigator: Glenn Gaston, MD
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • Recruiting
      • WellSpan Health
      • Principal Investigator: Richard Trevino, MD
  • Texas
    • San Antonio, Texas, United States, 78234
      • Recruiting
      • San Antonio Military Medical Center (SAMMC)
      • Principal Investigator: Jason Alderete, MD
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Recruiting
      • Virginia Commonwealth University Medical Center
      • Principal Investigator: Jonathan Issacs, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEG mediated reconstruction; NTX-001 will be administered topically via isolation chamber medical device. Dose Unit: 2.5 mL NTX-001 is a single use surgical product intended for use as adjunct treatment in the repair of severed peripheral nerves in patients requiring standard suture neurorrhaphy.	Drug: NTX-001; • PEG fusion is the application of a polyethylene glycol (PEG) using a combination of sequenced reagents to a freshly performed nerve coaptation, or neurorrhaphy, to allow the axonal membranes of the proximal and distal axonal stumps to fuse back together and re-establish full axonal continuity.
No Intervention: Conventional nerve reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications or problems that occur with in the first 30 days.	Complications or problems include surgical site infections, wound dehiscence/breakdown, exposure of nerves and/or their repairs and reconstructions, breakdown of nerve repair or reconstruction, seroma/hematoma requiring an additional procedure to treat, and any other local wound complications related to the zone of nerve injury that require an additional surgical procedure	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory Function	Sensory function will be evaluated using the the touch test mono-filament hand evaluation kit.	Up to 2 years
Motor Function	Motor function will be evaluated using the British Medical Research Council motor grading scale. Motor is evaluated on a scale of M0 and M5, where M5 is the highest score and M0 is the lowest.	Up to 2 years
Range of Motion	ROM will be measured using a standard goniometer.	Up to 2 years
Grip Strength	Grip strength is assessed using a hand-held Jamar dynamometer.	Up to 2 years
Pain Score	Self reported outcomes using the Brief Pain Inventory.	Up to 2 years
Patient Satisfaction with Treatment	Patient Satisfaction with Treatment is measured using the Short Form Patient Satisfaction Questionnaire (PSQ-18) at 24 months following injury.	Up to 2 years

Collaborators and Investigators

• Sponsor: Major Extremity Trauma Research Consortium
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Ala Elhelali, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Peripheral Nerve Injuries
• Other Study ID Numbers: W81XWH2010825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No