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

NCT02359825 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 191655
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Peripheral Nerve Injury

Outcome Measures

Primary Outcomes (1)

• return of nerve function as measured by (Medical Research Council Classificatoin (MRCC)

  Medical Research Council Classificatoin (MRCC)

  12 months

Study Arms (6)

standard epineural repair <24 hours

NO INTERVENTION

epineural repair following treatment with standard epineural repair alone in sensory nerve injuries in the upper extremity in short-term acute injuries (repaired \<24 hours after injury); no medication used

standard epineural repair >24 - 72 hours

NO INTERVENTION

epineural repair following irrigation with standard epineural repair alone in sensory nerve injuries in the upper extremity in short-term chronic injuries (\>24-\<72 hours after injury); no medication used

epineural repair with autografting within 48 hours

NO INTERVENTION

epineural repair with auto grafting within 48 hours; no medication used

epineural repair <24 hours using PEG

EXPERIMENTAL

epineural repair following treatment with standard epineural repair using PEG in sensory nerve injuries in the upper extremity in short-term acute injuries (repaired \<24 hours after injury); PEG is used during the surgical procedure

Drug: Polyethylene glycol (PEG)

epineural repair >24 but <72 hours using PEG

EXPERIMENTAL

epineural repair following treatment with standard epineural repair using PEG in sensory nerve injuries in the upper extremity in short-term acute injuries (repaired \>24 hours but \< 72 hours after injury); PEG is used during the surgical procedure

Drug: Polyethylene glycol (PEG)

epineural repair with autografting within 48 hours, using PEG

EXPERIMENTAL

epineural repair with auto grafting within 48 hours

Drug: Polyethylene glycol (PEG)

Interventions

Polyethylene glycol (PEG) DRUG

For the control groups, epineural repair or interposition grafting will be undertaken in the standard end-to-end fashion using interrupted nylon suture after irrigation of the wound with normal saline as deemed necessary by the operating surgeon. For the experimental group, the nerve(s) will be repaired using standard suture neurorrhaphy techniques and a 149.25 mM (50%) solution of PEG 3.35 kD in sterile water will then be irrigated onto the neurorrhaphy site for one minute. Following this, the approximated nerve ends will be irrigated with sterile water gently for 2 minutes. All wounds will be closed in the fashion deemed appropriate by the operating surgeon.

Also known as: PEG

epineural repair <24 hours using PEG; epineural repair >24 but <72 hours using PEG; epineural repair with autografting within 48 hours, using PEG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Nerve Injuries

Interventions

Polyethylene Glycols

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Wesley Thayer, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wesley Thayer, MD

CONTACT

615-936-0160; wesley.thayer@vanderbilt.edu

Julia Yao, BSN

CONTACT

615-343-8426; jun.yao@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHD

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 10, 2015
• Study Start: September 19, 2019
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)