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

February 25, 2026 updated by: Major Extremity Trauma Research Consortium

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Elizabeth Wysocki, MA
  • Phone Number: 410-955-0396
  • Email: ewysock2@jhu.edu

Study Contact Backup

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
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complications or problems that occur with in the first 30 days.
Time Frame: Up to 2 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensory Function
Time Frame: Up to 2 years
Sensory function will be evaluated using the the touch test mono-filament hand evaluation kit.
Up to 2 years
Motor Function
Time Frame: Up to 2 years
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
Time Frame: Up to 2 years
ROM will be measured using a standard goniometer.
Up to 2 years
Grip Strength
Time Frame: Up to 2 years
Grip strength is assessed using a hand-held Jamar dynamometer.
Up to 2 years
Pain Score
Time Frame: Up to 2 years
Self reported outcomes using the Brief Pain Inventory.
Up to 2 years
Patient Satisfaction with Treatment
Time Frame: Up to 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Major Extremity Trauma Research Consortium

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ala Elhelali, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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