Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusio
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 to
| Condition(s) | Peripheral Nerve Injuries |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 D |
| Who can participate | 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 n |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Major Extremity Trauma Research Consortium |
| Locations | Baltimore, Maryland, United States; Baltimore, Maryland, United States; Camden, New Jersey, United States; Charlotte, North Carolina, United States; York, Pennsylvania, United States; San Antonio, Texas, United States (+1 more sites) |
| Start date | 2023-06-01 |
| NCT ID | NCT04789044 |
| Official listing | https://clinicaltrials.gov/study/NCT04789044 |