Peripheral Nerve InjuryPhase 1NCT02359825
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
A Phase 1 study testing Polyethylene glycol (PEG) in people with Peripheral Nerve Injury, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Nerve Injury
- What is being tested?
- Polyethylene glycol (PEG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2019to 21 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
Read the detailed description
Our own preclinical animal studies have been designed to take advantage of PEG. We have used the fusogenic properties of PEG and this has allowed us to demonstrate a rapid and decisive electrophysiological recovery of either crushed or completely severed sciatic nerves in a commonly accepted mammalian model for peripheral nerve injury (Bittner et al JSR 2012).
Recently, we modified previously published mammalian techniques. Our goal was to eliminate laboratory solutions that have not been approved for use in humans and replace them with readily available reagents commonly used in clinical applications. PEG is commercially available in many molecular formulations and our earlier experiments with PEG having a molecular weight of 2 kD. Unfortunately, this molecular weight is not approved by the Food and Drug Administration (FDA) for human usage. In our more recent preclinical studies, we have demonstrated that PEG 3.35 kD, the main ingredient in the commonly used cathartic known as MiraLAX© (MERCK; Whitehouse Station, NJ), actually generates superior fusion over PEG 2KD in a cut nerve model. Thus the clinical trial that forms the basis of this proposal was developed with the FDA approved 3.35 kD PEG and these other two FDA approved solutions.
Additional studies in our complex nerve injury model have also demonstrated that the repair does not have to be performed immediately after nerve injury. Epineural repair with PEG 3.35 kD treatment can be performed up to 24hrs after injury and postoperative CAPs are obtained in all PEG 3.35 kD treated animals (n=3, data not shown). The remarkable finding is that in the 24-hour injury model, PEG significantly improves behavioral outcome measured at 72 hours postoperatively.
Based on the published reports and our own in vivo studies, we demonstrate that PEG based repair can restore CAPs immediately and improve functional recovery significantly post injury. These preclinical findings suggest that we can offer a novel therapy to test in humans who have experienced complete transection of a peripheral nerve. Patient risk is minimized as we have optimized the PEG facilitated fusion technique to utilize commonly used FDA approved drugs, solutions and electrolytes to augment standard neurorrhaphy techniques. The experimental protocol entails 100% transection injury to a peripheral nerve followed by a standard neurorrhaphy. The repair is then irrigated gently with PEG for two minutes and sterile water in standard fashion is used to wash away the PEG.
The most likely scenarios, that explain rapid compound action potential (CAP) restoration, are the rapid restoration of cytoplasmic flow within the nerves, the rapid ability of membranes to depolarize and possibly the prevention of Wallerian degeneration.
- Conditions
- Peripheral Nerve Injury
- Being tested
- Polyethylene glycol (PEG)
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycol (PEG)Drug
Also called PEG
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Polyethylene glycol (PEG) |
| epineural repair with autografting within 48 hours, using PEG | Experimental | epineural repair with auto grafting within 48 hours Receives: Drug: Polyethylene glycol (PEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
return of nerve function as measured by (Medical Research Council Classificatoin (MRCC)
Medical Research Council Classificatoin (MRCC)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study start19 Sep 2019
- Primary completion21 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuryStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wesley Thayer, Vanderbilt University
- Investigators
- Wesley Thayer, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359825
- Sponsor's protocol ID
- 191655
- Status last verified
- Oct 2025
- First submitted
- 4 Feb 2015
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
- ClinicalTrials.gov ID
- NCT02359825
- Acronym / sponsor ID
- 191655
- Conditions
- Peripheral Nerve Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Our own preclinical animal studies have been designed to take advantage of PEG. We have used the fusogenic properties of PEG and this has allowed us to demonstrate a rapid and decisive electrophysiological recovery of either crushed or completely severed sciatic nerves in a commonly accepted mammalian model for peripheral nerve injury (Bittner et al JSR 2012).
Recently, we modified previously published mammalian techniques. Our goal was to eliminate laboratory solutions that have not been approved for use in humans and replace them with readily available reagents commonly used in clinical applications. PEG is commercially available in many molecular formulations and our earlier experiments with PEG having a molecular weight of 2 kD. Unfortunately, this molecular weight is not approved by the Food and Drug Administration (FDA) for human usage. In our more recent preclinical studies, we have demonstrated that PEG 3.35 kD, the main ingredient in the commonly used cathartic known as MiraLAX© (MERCK; Whitehouse Station, NJ), actually generates superior fusion over PEG 2KD in a cut nerve model. Thus the clinical trial that forms the basis of this proposal was developed with the FDA approved 3.35 kD PEG and these other two FDA approved solutions.
Additional studies in our complex nerve injury model have also demonstrated that the repair does not have to be performed immediately after nerve injury. Epineural repair with PEG 3.35 kD treatment can be performed up to 24hrs after injury and postoperative CAPs are obtained in all PEG 3.35 kD treated animals (n=3, data not shown). The remarkable finding is that in the 24-hour injury model, PEG significantly improves behavioral outcome measured at 72 hours postoperatively.
Based on the published reports and our own in vivo studies, we demonstrate that PEG based repair can restore CAPs immediately and improve functional recovery significantly post injury. These preclinical findings suggest that we can offer a novel therapy to test in humans who have experienced complete transection of a peripheral nerve. Patient risk is minimized as we have optimized the PEG facilitated fusion technique to utilize commonly used FDA approved drugs, solutions and electrolytes to augment standard neurorrhaphy techniques. The experimental protocol entails 100% transection injury to a peripheral nerve followed by a standard neurorrhaphy. The repair is then irrigated gently with PEG for two minutes and sterile water in standard fashion is used to wash away the PEG.
The most likely scenarios, that explain rapid compound action potential (CAP) restoration, are the rapid restoration of cytoplasmic flow within the nerves, the rapid ability of membranes to depolarize and possibly the prevention of Wallerian degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Polyethylene glycol (PEG)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 |
| epineural repair >24 but <72 hours using PEG | Experimental | Drug: Polyethylene glycol (PEG)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 |
| epineural repair with autografting within 48 hours, using PEG | Experimental | Drug: Polyethylene glycol (PEG)epineural repair with auto grafting within 48 hours |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyethylene glycol (PEG)Also: PEGFor 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. | Drug | epineural repair <24 hours using PEG, epineural repair >24 but <72 hours using PEG, epineural repair with autografting within 48 hours, using PEG |
Primary outcome
return of nerve function as measured by (Medical Research Council Classificatoin (MRCC)
Time frame: 12 months
Medical Research Council Classificatoin (MRCC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wesley Thayer, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Polyethylene glycol (PEG) in people with Peripheral Nerve Injury, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
return of nerve function as measured by (Medical Research Council Classificatoin (MRCC) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.