Condition: Peripheral Nerve Injuries · Sponsor: Major Extremity Trauma Research Consortium
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.
This description comes directly from the study's public registry record.
Elizabeth Wysocki, MA · 410-955-0396 · ewysock2@jhu.edu
Ala Elhelali, PhD · 443-220-2537 · aelhela1@jhmi.edu
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT04789044