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Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)

Primary Purpose

Peripheral Nerve Injuries

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

NTX-001

About this trial

This is an interventional treatment trial for Peripheral Nerve Injuries

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ages 18-80
Sustained a complete peripheral nerve injury resulting from upper extremity trauma presenting within 48 hours of injury
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
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:

Patients beginning surgery within hours after injury.
Injury to the brachial plexus nerves
Injury to the nerves distal to the distal flexion crease of the wrist
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).
Previous peripheral nerve injury resulting from trauma, stroke, muscular, neurologic, or neuromuscular disorder
Documented psychiatric disorder that is expected to result in high probability of self-harm or interfere with study follow-up.
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).
Not expected to survive the next 30 days due to their injuries/health condition.
The subject has a known allergy to polyethylene glycol (PEG).
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.
The subject is pregnant and/or is breastfeeding.
The subject has a significant medical comorbidity precluding immediate repair.
The subject is not able to strictly adhere to the rules of the current clinical protocol.

Sites / Locations

University of Maryland Medical Center Shock Trauma Center
Johns Hopkins University School of MedicineRecruiting
Walter Reed National Military Medical Center
OrthoCarolina
Wellspan Health
San Antonio Military Medical Center (SAMMC)
Virginia Commonwealth University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PEG mediated reconstruction

Conventional nerve reconstruction

Arm Description

NTX-001 will be administered topically via isolation chamber medical device. Dose Unit: 2.5 mL NTX-001 is a single use surgical product intended for use as adjunct treatment in the repair of severed peripheral nerves in patients requiring standard suture neurorrhaphy.

Conventional nerve reconstruction

Outcomes

Primary Outcome Measures

Complications or problems that occur with in the first 30 days.

Complications or problems include surgical site infections, wound dehiscence/breakdown, exposure of nerves and/or their repairs and reconstructions, breakdown of nerve repair or reconstruction, seroma/hematoma requiring an additional procedure to treat, and any other local wound complications related to the zone of nerve injury that require an additional surgical procedure

Secondary Outcome Measures

Sensory Function

Sensory function will be evaluated using the the touch test mono-filament hand evaluation kit.

Motor Function

Motor function will be evaluated using the British Medical Research Council motor grading scale. Motor is evaluated on a scale of M0 and M5, where M5 is the highest score and M0 is the lowest.

Range of Motion

ROM will be measured using a standard goniometer.

Grip Strength

Grip strength is assessed using a hand-held Jamar dynamometer.

Pain Score

Self reported outcomes using the Brief Pain Inventory.

Patient Satisfaction with Treatment

Patient Satisfaction with Treatment is measured using the Short Form Patient Satisfaction Questionnaire (PSQ-18) at 24 months following injury.

Full Information

NCT ID

NCT04789044

First Posted

February 22, 2021

Last Updated

August 10, 2023

Sponsor

Major Extremity Trauma Research Consortium

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT04789044

Brief Title

Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)

Official Title

A Phase 2a Multicenter Randomized Controlled Trial Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion) Compared to Standard of Care in the Repair of Mixed Motor-sensory Acute Peripheral Nerve Injuries (PNI) for Rapid and Immediate Improvement in Outcome

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2023 (Actual)

Primary Completion Date

October 1, 2024 (Anticipated)

Study Completion Date

October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Major Extremity Trauma Research Consortium

Collaborators

United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The overall objective of this study is to determine the safety of PEG fusion when used with primary repair or reconstruction in patients with an acute upper extremity peripheral nerve injury. PEG is safe and effective for extending the half-life of circulating pharmaceutical products, when used in conjunction with a topical hemostatic agent in surgical wounds, and when used as a colon cleanser for endoscopic surgical procedures. However, PEG fusion has not been rigorously tested as a safe reagent to promote nerve regeneration in humans. Therefore, the goal of this Phase 2a clinical trial is to establish safety data and to examine the effect of PEG fusion on clinical outcomes including recovery of sensory and motor function. Results will be externally validated using data collected in the DoD funded prospective NERVE study and will provide preliminary evidence to power a larger phase II efficacy trial.

Detailed Description

The study will enroll 40 patients receiving autograft reconstruction within 24 hours of injury. Patients will be randomized to either PEG mediated reconstruction (n=20); or conventional nerve reconstruction (n=20). The investigators hypothesize that (1) the rate of complications within 1 month of surgery in patients treated with PEG fusion will be comparable to that of patients treated with conventional autograft reconstruction, (2) there will be no detrimental effects from PEG fusion on nerve regeneration over 2 years compared to patients treated with conventional nerve reconstruction, ((3) recovery of sensory and motor function will occur earlier (within 6 months) among patients treated with PEG fusion compared to patients treated with conventional autograft reconstruction (4) patients treated with PEG fusion will have better range of motion, greater hand strength, less disability, less pain, and higher rates of treatment satisfaction compared with patients treated with conventional autograft reconstruction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Nerve Injuries

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

The study will enroll 40 patients receiving autograft reconstruction within 24 hours of injury. Patients within each group will be randomized to either PEG mediated reconstruction (n=20); or conventional nerve reconstruction (n=20).

Masking

Participant

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PEG mediated reconstruction

Arm Type

Experimental

Arm Description

Arm Title

Conventional nerve reconstruction

Arm Type

No Intervention

Arm Description

Conventional nerve reconstruction

Intervention Type

Drug

Intervention Name(s)

NTX-001

Intervention Description

• PEG fusion is the application of a polyethylene glycol (PEG) using a combination of sequenced reagents to a freshly performed nerve coaptation, or neurorrhaphy, to allow the axonal membranes of the proximal and distal axonal stumps to fuse back together and re-establish full axonal continuity.

Primary Outcome Measure Information:

Title

Complications or problems that occur with in the first 30 days.

Description

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

Sensory Function

Description

Sensory function will be evaluated using the the touch test mono-filament hand evaluation kit.

Time Frame

Up to 2 years

Title

Motor Function

Description

Motor function will be evaluated using the British Medical Research Council motor grading scale. Motor is evaluated on a scale of M0 and M5, where M5 is the highest score and M0 is the lowest.

Time Frame

Up to 2 years

Title

Range of Motion

Description

ROM will be measured using a standard goniometer.

Time Frame

Up to 2 years

Title

Grip Strength

Description

Grip strength is assessed using a hand-held Jamar dynamometer.

Time Frame

Up to 2 years

Title

Pain Score

Description

Self reported outcomes using the Brief Pain Inventory.

Time Frame

Up to 2 years

Title

Patient Satisfaction with Treatment

Description

Patient Satisfaction with Treatment is measured using the Short Form Patient Satisfaction Questionnaire (PSQ-18) at 24 months following injury.

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ages 18-80 Sustained a complete peripheral nerve injury resulting from upper extremity trauma presenting within 48 hours of injury 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 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: Patients beginning surgery within hours after injury. Injury to the brachial plexus nerves Injury to the nerves distal to the distal flexion crease of the wrist 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). Previous peripheral nerve injury resulting from trauma, stroke, muscular, neurologic, or neuromuscular disorder Documented psychiatric disorder that is expected to result in high probability of self-harm or interfere with study follow-up. 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). Not expected to survive the next 30 days due to their injuries/health condition. The subject has a known allergy to polyethylene glycol (PEG). 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. The subject is pregnant and/or is breastfeeding. The subject has a significant medical comorbidity precluding immediate repair. The subject is not able to strictly adhere to the rules of the current clinical protocol.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elizabeth Wysocki, MS

Phone

410-955-0396

ewysock2@jhu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Ala Elhelali, Ph.D

Phone

443-220-2537

aelhela1@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaimie Shores, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Maryland Medical Center Shock Trauma Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ray Pensy, MD

Facility Name

Johns Hopkins University School of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21213

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jaimie Shores, MD

Facility Name

Walter Reed National Military Medical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20889

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jason Souza, MD

Facility Name

OrthoCarolina

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Glenn Gaston, MD

Facility Name

Wellspan Health

City

York

State/Province

Pennsylvania

ZIP/Postal Code

17403

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Richard Trevino, MD

Facility Name

San Antonio Military Medical Center (SAMMC)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jason Alderete, MD

Facility Name

Virginia Commonwealth University Medical Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23219

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jonathan Issacs, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)

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