Using PEG to repair severed nerves for faster recovery

Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function

This study is testing whether a special gel can help people with cut nerves heal faster and get their function back sooner.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT02359825 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of polyethylene glycol (PEG) to enhance the repair of severed peripheral nerves, aiming to promote immediate fusion of axons and a quicker return of function. The study builds on preclinical findings that demonstrated superior nerve recovery using PEG 3.35 kD, an FDA-approved formulation. Participants will undergo nerve repair within 48 hours of injury, and the trial will assess both the safety and efficacy of this innovative approach over a 12-month period.

Who should consider this trial

Good fit: Ideal candidates are individuals with a Sunderland Class 5 traumatic neuropathy of a digital nerve in the upper extremity, requiring immediate surgical repair.

Not a fit: Patients with grossly contaminated injuries, inadequate soft tissue coverage, or those with significant comorbidities such as diabetes or neuromuscular diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce recovery time for patients with peripheral nerve injuries.

How similar studies have performed: While this approach is based on promising preclinical results, it represents a novel application in human subjects and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

* Diagnosis of a Sunderland Class 5 traumatic neuropathy (transection injury) of a digital nerve in the upper extremity
* candidates for immediate operative repair (Arm 1);
* injury proceeding repair no longer than 72 hours; and
* repair within 48 hours of injury that require nerve grafting;
* N0 significant medical comorbidities precluding immediate repair;
* willing to comply with all aspects of the treatment and evaluation schedule over a 12 months period.

We plan to include subjects who have peripheral nerve injuries that are complicated by significant vascular or orthopedic damage.

Exclusion Criteria:

* Patients will be excluded from enrollment if their injuries exhibit gross contamination, in circumstances where soft tissue coverage is inadequate, or when staged repair is planned.
* We will also exclude patients that are diabetic, have been diagnosed with a neuromuscular disease, or are undergoing chemotherapy, radiation therapy, or other treatments known to affect the growth of the neural and vascular system.
* We will exclude all patients currently enrolled in another investigational study or those who are unlikely to complete the normal regime of occupational therapy. Individuals will be excluded from participation if their time of injury falls outside study parameters.

Where this trial is running

Nashville, Tennessee

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Wesley Thayer, MD — Vanderbilt University Medical Center
• Study coordinator: Wesley Thayer, MD

Conditions Peripheral Nerve Injury