Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)
Status:
Not yet recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
Summary
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.