Actively Recruiting
Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)
Led by Major Extremity Trauma Research Consortium · Updated on 2026-02-27
40
Participants Needed
7
Research Sites
278 weeks
Total Duration
On this page
Sponsors
M
Major Extremity Trauma Research Consortium
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 80 years
- Complete peripheral nerve injury from upper extremity trauma within 48 hours
- Injury affects motor and/or sensory function of axillary, radial, median, ulnar, or musculocutaneous nerve between proximal humerus and wrist crease
- Injury involves mixed nerve segments containing both sensory and motor axons
You will not qualify if you...
- Surgery beginning within hours after injury
- Injury to brachial plexus nerves
- Injury to nerves beyond the wrist crease
- Injury involving sensory-only nerve branches distal to the wrist crease
- Previous peripheral nerve injury from trauma, stroke, or neurological disorders
- Psychiatric disorders posing risk of self-harm or interfering with follow-up
- Severe difficulty maintaining follow-up (e.g., prisoners, homeless, intellectually challenged without support)
- Expected to survive less than 30 days due to injury or health
- Known allergy to polyethylene glycol (PEG)
- Inability to perform baseline assessments on the opposite side or abnormal sensory test results
- Pregnancy or breastfeeding
- Significant medical conditions preventing immediate repair
- Inability to follow the clinical protocol strictly
AI-Screening
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Trial Site Locations
Total: 7 locations
1
University of Maryland Medical Center Shock Trauma Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
2
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21213
Actively Recruiting
3
Cooper Health
Camden, New Jersey, United States, 08103
Actively Recruiting
4
OrthoCarolina
Charlotte, North Carolina, United States, 28207
Actively Recruiting
5
Wellspan Health
York, Pennsylvania, United States, 17403
Actively Recruiting
6
San Antonio Military Medical Center (SAMMC)
San Antonio, Texas, United States, 78234
Actively Recruiting
7
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23219
Actively Recruiting
Research Team
E
Elizabeth Wysocki, MA
CONTACT
A
Ala Elhelali, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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