Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT02359825

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

Led by Vanderbilt University Medical Center · Updated on 2025-10-20

18

Participants Needed

1

Research Sites

458 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Current strategies for peripheral nerve repair are severely limited. Even with current techniques, it can take months for regenerating axons to reach denervated target tissues when injuries are proximally located. This inability to rapidly restore the loss of function after axonal injury continues to produce poor clinical outcomes. The investigators propose testing the efficacy and safety of a combination therapy: polyethylene glycol (PEG) assisted axonal fusion technique to repair peripheral nerve injuries in humans.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of a Sunderland Class 5 traumatic neuropathy (complete transection) of a digital nerve in the upper extremity
  • Candidate for immediate operative repair
  • Injury occurred no longer than 72 hours before repair
  • Repair within 48 hours of injury requiring nerve grafting
  • No significant medical conditions that prevent immediate repair
  • Willingness to follow all treatment and evaluation schedules for 12 months
  • Includes patients with peripheral nerve injuries complicated by vascular or orthopedic damage
Not Eligible

You will not qualify if you...

  • Injuries with gross contamination or inadequate soft tissue coverage
  • Planned staged nerve repair
  • Diagnosis of diabetes or neuromuscular disease
  • Undergoing chemotherapy, radiation, or treatments affecting nerve or blood vessel growth
  • Currently enrolled in another investigational study
  • Unlikely to complete required occupational therapy
  • Injury occurred outside the study time limits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

W

Wesley Thayer, MD

CONTACT

J

Julia Yao, BSN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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