Injury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial EncounterPhase 1NCT03236064
Conversion of Seddon III Nerve Injury to Seddon I/II Nerve Injury
A Phase 1 study testing Polyethylene Glycols in people with Injury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial Encounter, run by WellSpan Health at 1 site in United States.
Trial summary
This study will evaluate the safety and efficacy of PEG 3350 for use in nerve repair. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Injury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial Encounter
- What is being tested?
- Polyethylene Glycols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Nov 2022
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Isolated nerve transections of the digits, forearm, wrist, and palm will be included.
- Class III nerve injury (Sunderland's 4th or 5th degree injury)
- Nerve injuries that can be prepared using minimal or acceptable tension (according to surgeon discretion).
- Pregnant and breastfeeding women cannot participate because of possible unknown and unpredictable risks to the unborn child.
- Injuries beyond 24 hours will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the safety and efficacy of PEG 3350 for use in nerve repair.
Read the detailed description
To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques. Neurorrhaphy is not new, being performed now for over 150 years much research has been performed. PEG-Axon fusion on the other hand is relatively new in mammals. Success has already been obtained by two institutions in the rat sciatic nerve transections, demonstrating rapid return of behavioral function4. These however are very controlled injuries and unclear how well these will translate into human studies. For this reason 3 separate clinical studies in increasing order of complexity are proposed.
The first study proposed will be PEG fusion in digital nerve lacerations. Two goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure.
- Being tested
- Polyethylene Glycols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene GlycolsDrug
Demonstrate more rapid and increased return of function by PEG-fusion compared to best current nerve repair techniques
| Study group | Role | What they receive |
|---|---|---|
| Nerve injury to palm and fingers | Experimental | Adult patients with acute clean nerve transections of the higher arm injuries in the forearm, wrist, palm and digits of the hand will be recruited Receives: Drug: Polyethylene Glycols |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques
Three goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, rapid return of motor function and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure
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 posted1 Aug 2017
- Study startMay 2016
- Primary completionNov 2022
- Study completionNov 2022
Why it stopped: opening a new study with sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial EncounterStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- WellSpan Health
- Sponsor type
- University, hospital or other
- Collaborators
- Neuraptive Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Richard C Trevino, MD, Principal investigator, WellSpan York Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236064
- Sponsor's protocol ID
- 696230-1
- Status last verified
- Mar 2023
- First submitted
- 25 Jul 2016
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion of Seddon III Nerve Injury to Seddon I/II Nerve Injury
- ClinicalTrials.gov ID
- NCT03236064
- Acronym / sponsor ID
- 696230-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: opening a new study with sponsor
- Enrolment
- 4 participants (actual)
- Lead sponsor
- WellSpan HealthUniversity, hospital or other
- Collaborators
- Neuraptive Therapeutics Inc.
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2022 (actual)
- Study completion
- Nov 2022 (actual)
- First posted
- 1 Aug 2017 (actual)
- 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.
This study will evaluate the safety and efficacy of PEG 3350 for use in nerve repair.
Detailed description
To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques. Neurorrhaphy is not new, being performed now for over 150 years much research has been performed. PEG-Axon fusion on the other hand is relatively new in mammals. Success has already been obtained by two institutions in the rat sciatic nerve transections, demonstrating rapid return of behavioral function4. These however are very controlled injuries and unclear how well these will translate into human studies. For this reason 3 separate clinical studies in increasing order of complexity are proposed.
The first study proposed will be PEG fusion in digital nerve lacerations. Two goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerve injury to palm and fingers | Experimental | Drug: Polyethylene GlycolsAdult patients with acute clean nerve transections of the higher arm injuries in the forearm, wrist, palm and digits of the hand will be recruited |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 GlycolsDemonstrate more rapid and increased return of function by PEG-fusion compared to best current nerve repair techniques | Drug | Nerve injury to palm and fingers |
Primary outcome
To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques
Time frame: 12 months
Three goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, rapid return of motor function and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure
Results and safety
The study was stopped early (reason given: opening a new study with sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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.
Richard C Trevino, MD principal investigator
WellSpan York Hospital
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 Glycols in people with Injury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial Encounter, run by WellSpan Health 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?
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: stopped early, as of the sponsor's last update on 19 Aug 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 was stopped early (reason given: opening a new study with sponsor). Results are not available in the source record.
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?
To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques (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 19 Aug 2026.