RECRUITING

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

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Conditions

Peripheral Nerve Injuries

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Study Overview

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Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-01
Study Completion:2024-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04789044

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ages 18-80
  2. 2. Sustained a complete peripheral nerve injury resulting from upper extremity trauma presenting within 48 hours of injury
  3. 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. 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).
  1. 1. Patients beginning surgery within hours after injury.
  2. 2. Injury to the brachial plexus nerves
  3. 3. Injury to the nerves distal to the distal flexion crease of the wrist
  4. 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. 5. Previous peripheral nerve injury resulting from trauma, stroke, muscular, neurologic, or neuromuscular disorder
  6. 6. Documented psychiatric disorder that is expected to result in high probability of self-harm or interfere with study follow-up.
  7. 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. 8. Not expected to survive the next 30 days due to their injuries/health condition.
  9. 9. The subject has a known allergy to polyethylene glycol (PEG).
  10. 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. 11. The subject is pregnant and/or is breastfeeding.
  12. 12. The subject has a significant medical comorbidity precluding immediate repair.
  13. 13. The subject is not able to strictly adhere to the rules of the current clinical protocol.

Contacts and Locations

Study Contact

Elizabeth Wysocki, MS
CONTACT
410-955-0396
ewysock2@jhu.edu
Ala Elhelali, Ph.D
CONTACT
443-220-2537
aelhela1@jhmi.edu

Principal Investigator

Jaimie Shores, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

University of Maryland Medical Center Shock Trauma Center
Baltimore, Maryland, 21201
United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21213
United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
United States
OrthoCarolina
Charlotte, North Carolina, 28207
United States
Wellspan Health
York, Pennsylvania, 17403
United States
San Antonio Military Medical Center (SAMMC)
San Antonio, Texas, 78234
United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23219
United States

Collaborators and Investigators

Sponsor: Major Extremity Trauma Research Consortium

  • Jaimie Shores, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-06-01
Study Completion Date2024-10-01

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2024-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Peripheral Nerve Injuries