New gel fusion technique aims to speed nerve repair after traumatic arm injuries
NCT ID NCT04789044
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This study tests whether a substance called polyethylene glycol (PEG) can help reconnect severed nerves in the arm more effectively than standard surgery. About 40 adults with a recent, complete nerve injury from trauma will receive either PEG plus standard repair or standard repair alone. The main goal is to check safety and see if PEG improves recovery of movement and feeling.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Ages 18-80 2. Sustained a complete peripheral nerve injury resulting from upper extremity trauma presenting within 48 hours of injury 3. Involves injury or dysfunction to motor and/or sensory function of the axillary, radial, median, ulnar, or musculocutaneous nerve with injury localized between the proximal humerus and the distal flexion crease of the wrist 4. Involves a "mixed" nerve segment (i.e., involves a location of any of the above specified nerves that can be expected to have both sensory and motor axons present). Exclusion Criteria: 1. Patients beginning surgery within hours after injury. 2. Injury to the brachial plexus nerves 3. Injury to the nerves distal to the distal flexion crease of the wrist 4. Injury that involves a distal extension of the parent nerve that is considered sensory only (superficial radial nerve, lateral antebrachial cutaneous nerve, etc.) or the posterior interosseus or anterior interosseus nerve distal to the midpoint of the forearm (i.e., distal to what can be considered the main motor branches of the PIN and AIN). 5. Previous peripheral nerve injury resulting from trauma, stroke, muscular, neurologic, or neuromuscular disorder 6. Documented psychiatric disorder that is expected to result in high probability of self-harm or interfere with study follow-up. 7. Severe problems with maintaining follow up (e.g., patients who are prisoners or homeless at time of injury or who are intellectually challenged without adequate family support). 8. Not expected to survive the next 30 days due to their injuries/health condition. 9. The subject has a known allergy to polyethylene glycol (PEG). 10. If any of the assessments cannot be done on the contralateral side (CL) or the MRCC sensory 2PD value is \> 10 mm on the CL side during baseline period, the subject is a screen failure. 11. The subject is pregnant and/or is breastfeeding. 12. The subject has a significant medical comorbidity precluding immediate repair. 13. The subject is not able to strictly adhere to the rules of the current clinical protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cooper Health
Camden, New Jersey, 08103, United States
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Johns Hopkins University School of Medicine
Baltimore, Maryland, 21213, United States
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OrthoCarolina
Charlotte, North Carolina, 28207, United States
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San Antonio Military Medical Center (SAMMC)
San Antonio, Texas, 78234, United States
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University of Maryland Medical Center Shock Trauma Center
Baltimore, Maryland, 21201, United States
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Virginia Commonwealth University Medical Center
Richmond, Virginia, 23219, United States
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Wellspan Health
York, Pennsylvania, 17403, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A 10-minute electric pulse during nerve surgery may speed up arm recovery
- Magnetic pulses aim to ease nerve pain without drugs
- Could a One-Hour shock boost nerve repair after severe arm injury?
- Hand rehab revolution? early data may predict recovery months ahead
- Electric zaps to wrist muscles may speed hand recovery after nerve surgery
- Brain training with mirrors and zaps: new hope for nerve injury recovery?