CLINICAL TRIAL

Polyethylene glycol (PEG) for Peripheral Nerve Injuries

Class V
Recruiting · 18+ · All Sexes · Nashville, TN

This study is evaluating whether a new technique for repairing peripheral nerve injuries may help improve recovery.

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About the trial for Peripheral Nerve Injuries

Eligible Conditions
or Peripheral Nerve Injury (PNI) · Peripheral Nerve Injuries

Treatment Groups

This trial involves 3 different treatments. Polyethylene Glycol (PEG) is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Polyethylene glycol (PEG)
DRUG
Experimental Group 2
Polyethylene glycol (PEG)
DRUG
Experimental Group 3
Polyethylene glycol (PEG)
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polyethylene glycol (PEG)
2016
Completed Phase 4
~1520

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
injury proceeding repair no longer than 72 hours;
repair within 48 hours of injury that require nerve grafting;
N0 significant medical comorbidities precluding immediate repair;
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);
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.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Polyethylene glycol (PEG) will improve 1 primary outcome in patients with Peripheral Nerve Injuries. Measurement will happen over the course of 12 months.

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

Who is running the study

Principal Investigator
W. T.
Wesley Thayer, PhD
Vanderbilt University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is polyethylene glycol (peg) safe for people?

PEG-based solutions may be effective in reducing pain in selected people with chronic pelvic pain syndrome. The evidence base for PEG as adjunctive therapy to opioids, however, is limited. The evidence for possible long-term benefits is also limited, and the most effective PEG-based solution requires further study.

Anonymous Patient Answer

What is the average age someone gets peripheral nerve injuries?

The literature is ambiguous regarding the average age of peripheral nerve injuries; the vast majority of the available data points towards an older age of onset in the literature by decades. This age may have an impact on the patient's expectations in rehabilitation programmes.

Anonymous Patient Answer

What are the signs of peripheral nerve injuries?

The symptoms of a PNI depend largely on the position of the lesion. Patients presenting to the emergency department with unilateral lower limb symptoms may have a lesion at the upper thigh or lower leg. Patients with a bilateral or unilateral leg PNI presenting to the emergency department with pain in the feet, lower back or buttocks may have a lesion in the pelvis or lower back. Patients presenting with pain in the feet and lower leg are likely to have sciatica. Patients presenting with unilateral buttock pain, unilateral groin pain and pain in the foot have lesions in the lower leg or foot with sciatica a possibility. Any of these features should raise the possibility of PNI and requires further investigation and management.

Anonymous Patient Answer

What are common treatments for peripheral nerve injuries?

The most commonly used treatments are for acute nerve injuries. Nerves with nerve pain were relieved by splinting, compression, or decompression at 9.8% of cases in a study conducted by a pediatric emergency physician. In general, there are no studies that compare the outcome of each treatment; however, in all three treatments, outcome was mostly good.

Anonymous Patient Answer

Can peripheral nerve injuries be cured?

The current scientific data does not support the proposition that peripheral nerve injuries can be successfully cured. Clinical and animal studies have demonstrated the potential harmful consequences of regenerating neural axons after severe axon transection injuries. As such, nerve regenerative medicine is a promising area for more research in the future to find therapies for patients with injuries that are serious, debilitating, and often irreversible.

Anonymous Patient Answer

How many people get peripheral nerve injuries a year in the United States?

The American Medical Association estimates 7.4 million American children have an NIs in their lifetime. In a recent study, findings suggests that around 15% of them have serious injury, resulting in more than 2 million long-term physical and economic damage to their families.

Anonymous Patient Answer

What causes peripheral nerve injuries?

As traumatic nerve injuries result in functional deficits, the current investigation focuses on a model of chronic nerve injury resulting in an irreversible and prolonged decline in the function of multiple sensory and motor neurons. By studying these injuries in this model, it is possible to discover possible molecular mechanisms for nerve damage and to elucidate the role of the local microenvironment surrounding peripheral nerve injuries.

Anonymous Patient Answer

How serious can peripheral nerve injuries be?

Patients with serious peripheral nerve injuries are often left to suffer a significant long-term disability. While the risk of persistent disabling disability may be increased, the risk of death is not significantly increased. When a significant deficit after injury has become apparent or becomes evident, it can be treated and managed as a chronic condition.

Anonymous Patient Answer

Have there been other clinical trials involving polyethylene glycol (peg)?

Recent findings showed PEG did not work for people with nerve damage. There is more evidence that PEG is not appropriate to use for people suffering from nerve damage.

Anonymous Patient Answer

What is peripheral nerve injuries?

Peripheral nerve injuries arise when a vital nerve is cut or broken. These injuries affect movement and sensation, often causing disabling symptoms. This is true in either the upper or lower limbs. Peripheral nerves make up the largest part of a limb, including the nerves, blood vessels and muscles, and most peripheral nerve injuries have repercussions on the limb. Therefore, diagnosis and treatment of peripheral nerve injuries requires the knowledge of the anatomy of the limb and an examination of the function of the limb. Peripheral nerve injuries are not usually fatal and are managed by the use of pain medicines and exercise. Peripheral nerve injuries usually only recover completely when the nerve is reconstructed.\n\nIn 2013, the US hospital market was $1.

Anonymous Patient Answer

Who should consider clinical trials for peripheral nerve injuries?

Clinical trials for peripheral nerve injuries need to be targeted towards those suffering from chronic pain or those with neurological disability that are refractory to conventional treatment.

Anonymous Patient Answer

Does peripheral nerve injuries run in families?

We did not find any evidence supporting a familial pattern of peripheral nerve injuries. Peripheral neuropathies are probably multifactorial in etiology and do not run in families.

Anonymous Patient Answer
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