Peripheral Nerve InjuryPhase 1/2NCT04270019
Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration
A Phase 1/2 study testing Polyethylene Glycol 3350 and Normal Saline in people with Peripheral Nerve Injury and Nerve Injury, run by Nova Scotia Health Authority.
Trial summary
PEG is a fusogen, a type of chemical that aids in mediating cell fusion. PEG helps nerve cells recover neuronal continuity by removing plasmalemmal-bound water which opens the axonal ends on both sides of the injury. Opening axonal ends permits the nerve ends to reconnect and begin regeneration. Read more about this study
- Who is it for?
- Ages 16 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Nerve Injury, Nerve Injury
- What is being tested?
- Polyethylene Glycol 3350 and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 26 Jun 2020to 15 Sep 2023
- Phase
- Phase 1/2
- 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 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- (1) surgery within twenty-four hours of injury (2) surgery completed in the minor procedures unit of the Halifax Infirmary.
Who cannot join
- (1) patients with cognitive impairment
About this study
Official title: The Use of Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration: A Randomized Controlled Trial
PEG is a fusogen, a type of chemical that aids in mediating cell fusion. PEG helps nerve cells recover neuronal continuity by removing plasmalemmal-bound water which opens the axonal ends on both sides of the injury. Opening axonal ends permits the nerve ends to reconnect and begin regeneration. PEG has been tested on animal models extensively and in earthworm models has been shown to induce fusion rates in 80-100% of neuronal cells. In crushed or severed mammalian sciatic nerves PEG has enhanced neuronal continuity to baseline functioning levels.
Human applications for PEG have been tested by Bamba and colleagues in a case series with encouraging results. No studies, to our knowledge, have prospectively examined the use of PEG in peripheral nerve injuries. We propose a placebo controlled, double-blinded randomized controlled trial to test the hypothesis that local PEG administration can enhance sensory nerve regeneration following digital nerve transection compared to surgery alone.
- Conditions
- Peripheral Nerve Injury, Nerve Injury
- Being tested
- Polyethylene Glycol 3350, Normal Saline
- 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 3350Drug
In order to prepare PEG 3350 50% weight/volume, 25 grams of the sterilized PEG 3350 will be measured out and placed into a sterilized glass bottle then 25 mL of sterile water will be added. The solution will be allowed to rest for 10 minutes so that dissolution may occur. More sterile water will then be added so the total volume is 50mL. This solution will then be sterilized by the Halifax Health Infirmary pharmacy department using a liquid autoclave cycle of 120 degrees Celsius for 20 minutes in a glass vial. The 50 mL solution will be portioned into 2mL sterilized glass vials using a standard aseptic technique. The solutions will be kept at a solid frozen state between negative 25 degrees Celsius and negative 10 degrees Celsius for a maximum of 45 days. The solutions will be removed from storage on the day of surgical utilization in order to ensure storage guidelines are kept to the highest standards.
Normal SalineDrug
Standard solution of sterile normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | This group will receive polyethylene glycol (50% weight/volume) applied to the nerve coaptation site during primary repair of peripheral nerve injury in the hand. Receives: Drug: Polyethylene Glycol 3350 |
| Control | Placebo comparator | This group will receive normal saline applied to the nerve coaptation site during primary repair of peripheral nerve injury in the hand. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sensory Recovery
Sensory recovery will be assessed by a blinded and trained OT through standardized testing with static two point discrimination (s2PD) and Semmes-Weinstein monofilament testing (SWMT). The end point will be composite in nature as both s2PD and SWMT are important to gauge and are the gold standards in determining sensory recovery.
Measured: Testing to be done at one month, three months, and six months post-operatively.
Secondary outcomes (1)
Functional Recovery
Functional recovery assessed by the Michigan Health Questionnaire (MHQ).
Measured: Administered six months post-operatively. Maximum score of 100, minimum score of 0. A higher score means better functional recovery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start26 Jun 2020
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Why it stopped: lack of staff, REB closed the file due to expired renewal
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 Nova Scotia Health AuthorityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This study will be a randomized, double-blind, placebo-controlled human clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270019
- Sponsor's protocol ID
- 0644
- Status last verified
- Jan 2024
- First submitted
- 12 Feb 2020
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04270019
- Acronym / sponsor ID
- 0644
- Conditions
- Peripheral Nerve Injury, Nerve Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of staff, REB closed the file due to expired renewal
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 17 Feb 2020 (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.
PEG is a fusogen, a type of chemical that aids in mediating cell fusion. PEG helps nerve cells recover neuronal continuity by removing plasmalemmal-bound water which opens the axonal ends on both sides of the injury. Opening axonal ends permits the nerve ends to reconnect and begin regeneration. PEG has been tested on animal models extensively and in earthworm models has been shown to induce fusion rates in 80-100% of neuronal cells. In crushed or severed mammalian sciatic nerves PEG has enhanced neuronal continuity to baseline functioning levels.
Human applications for PEG have been tested by Bamba and colleagues in a case series with encouraging results. No studies, to our knowledge, have prospectively examined the use of PEG in peripheral nerve injuries. We propose a placebo controlled, double-blinded randomized controlled trial to test the hypothesis that local PEG administration can enhance sensory nerve regeneration following digital nerve transection compared to surgery alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be a randomized, double-blind, placebo-controlled human clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Polyethylene Glycol 3350This group will receive polyethylene glycol (50% weight/volume) applied to the nerve coaptation site during primary repair of peripheral nerve injury in the hand. |
| Control | Placebo comparator | Drug: Normal SalineThis group will receive normal saline applied to the nerve coaptation site during primary repair of peripheral nerve injury in the hand. |
Who may qualify
- Ages
- 16 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- (1) surgery within twenty-four hours of injury (2) surgery completed in the minor procedures unit of the Halifax Infirmary.
Key exclusion criteria (1 listed)
- (1) patients with cognitive impairment
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 3350In order to prepare PEG 3350 50% weight/volume, 25 grams of the sterilized PEG 3350 will be measured out and placed into a sterilized glass bottle then 25 mL of sterile water will be added. The solution will be allowed to rest for 10 minutes so that dissolution may occur. More sterile water will then be added so the total volume is 50mL. This solution will then be sterilized by the Halifax Health Infirmary pharmacy department using a liquid autoclave cycle of 120 degrees Celsius for 20 minutes in a glass vial. The 50 mL solution will be portioned into 2mL sterilized glass vials using a standard aseptic technique. The solutions will be kept at a solid frozen state between negative 25 degrees Celsius and negative 10 degrees Celsius for a maximum of 45 days. The solutions will be removed from storage on the day of surgical utilization in order to ensure storage guidelines are kept to the highest standards. | Drug | Experimental |
| Normal SalineStandard solution of sterile normal saline. | Drug | Control |
Primary outcome
Change in Sensory Recovery
Time frame: Testing to be done at one month, three months, and six months post-operatively.
Sensory recovery will be assessed by a blinded and trained OT through standardized testing with static two point discrimination (s2PD) and Semmes-Weinstein monofilament testing (SWMT). The end point will be composite in nature as both s2PD and SWMT are important to gauge and are the gold standards in determining sensory recovery.
1 secondary outcome
Functional Recovery
Time frame: Administered six months post-operatively. Maximum score of 100, minimum score of 0. A higher score means better functional recovery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Polyethylene Glycol 3350 and Normal Saline in people with Peripheral Nerve Injury and Nerve Injury, run by Nova Scotia Health Authority.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Change in Sensory Recovery (time frame: Testing to be done at one month, three months, and six months post-operatively.). 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 5 Jan 2024.