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

Last updated: December 17, 2024
Sponsor: Major Extremity Trauma Research Consortium
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

NTX-001

Clinical Study ID

NCT04789044
W81XWH2010825
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ages 18-80

  2. Sustained a complete peripheral nerve injury resulting from upper extremity traumapresenting 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 theproximal humerus and the distal flexion crease of the wrist

  4. Involves a "mixed" nerve segment (i.e., involves a location of any of the abovespecified nerves that can be expected to have both sensory and motor axons present).

Exclusion

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 consideredsensory only (superficial radial nerve, lateral antebrachial cutaneous nerve, etc.)or the posterior interosseus or anterior interosseus nerve distal to the midpoint ofthe forearm (i.e., distal to what can be considered the main motor branches of thePIN 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 ofself-harm or interfere with study follow-up.

  7. Severe problems with maintaining follow up (e.g., patients who are prisoners orhomeless at time of injury or who are intellectually challenged without adequatefamily 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 MRCCsensory 2PD value is > 10 mm on the CL side during baseline period, the subject is ascreen 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 clinicalprotocol.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: NTX-001
Phase: 2
Study Start date:
June 01, 2023
Estimated Completion Date:
October 01, 2026

Study 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.

Connect with a study center

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland 21213
    United States

    Active - Recruiting

  • University of Maryland Medical Center Shock Trauma Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Walter Reed National Military Medical Center

    Bethesda, Maryland 20889
    United States

    Site Not Available

  • OrthoCarolina

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Wellspan Health

    York, Pennsylvania 17403
    United States

    Site Not Available

  • San Antonio Military Medical Center (SAMMC)

    San Antonio, Texas 78234
    United States

    Site Not Available

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia 23219
    United States

    Site Not Available

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