Axon Therapy and Conventional Medical Management for Painful Diabetic Neuropathy Compared to Sham and Conventional Medical Management

NCT05620225 | Completed FDA Device

• 1 other identifier: NLM-004
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 7

Brief Summary

Compare Axon Therapy plus conventional medical management (CMM) to Sham plus CMM in reducing neuropathic pain in patients with painful diabetic neuropathy (PDM).

Conditions

Neuralgia; Neuropathic Pain; Painful Diabetic Neuropathy

Keywords

transcutaneous magnetic stimulation; axon therapy; peripheral neuropathic pain; diabetic neuropathy

Outcome Measures

Primary Outcomes (2)

• Comparison of the Proportion of Responders

  The primary efficacy endpoint is a between groups comparison of pain change from baseline to 30 days.

  30 days

• Comparison of therapy-related AEs between the 2 Study arms

  The primary safety endpoint for this study is a comparison of therapy-related AEs through Day 30 between the 2 arms of the Study.

  30 days

Secondary Outcomes (13)

• Visual Analog Scale (VAS) for Pain

  30- and 90-days post-treatment

• VAS for Numbness

  30- and 90-days post-treatment

• Brief Pain Inventory (BPI)

  30- and 90-days post-treatment

• Daily Sleep Interference Scale (DSIS)

  30- and 90-days post-treatment

• EQ-5D-3L

  30- and 90-days post-treatment

Study Arms (2)

Axon Therapy + CMM

EXPERIMENTAL

Subjects will be consented, screened, and then undergo a 7-day baseline assessment period. Subjects will be asked to record pain, numbness, and sleep scores via a twice daily electronic diary. Subjects who meet inclusion criteria, including diary compliance, will undergo an in-clinic baseline evaluation (Day 1), be randomized, and start their treatments. All subjects will return to the clinic for treatments as follows: ● Day 1 - 30: 6 treatments * Week 1: 3 treatments * Week 2-4: Weekly treatments All subjects will return to the clinic for follow-up assessment at Day 30 (± 5 days). At the Day 30 visits subjects will be asked if they want to participate in Phase 2 of the study.

Device: Axon Therapy and CMM

Sham + CMM

SHAM COMPARATOR

Subjects will be consented, screened, and then undergo a 7-day baseline assessment period. Subjects will be asked to record pain, numbness, and sleep scores via a twice daily electronic diary. Subjects who meet inclusion criteria, including diary compliance, will undergo an in-clinic baseline evaluation (Day 1), be randomized, and start their treatments. All subjects will return to the clinic for treatments as follows: ● Day 1 - 30: 6 treatments * Week 1: 3 treatments * Week 2-4: Weekly treatments All subjects will return to the clinic for follow-up assessment at Day 30 (± 5 days). At the Day 30 visits subjects will be asked if they want to participate in Phase 2 of the study.

Device: Sham and CMM

Interventions

Axon Therapy and CMM DEVICE

transcutaneous magnetic stimulation (TMS)

Axon Therapy + CMM

Sham and CMM DEVICE

Sham and CMM

Sham + CMM

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the study.
• Subject is willing and able to comply with scheduled visits, treatment plan, daily pain, and other study procedures subject is able and willing to complete twice daily electronic diary for up to 60 days.
• Subject must be literate in English to fill out the study questionnaires.
• Men or women of any race or ethnicity who are 18-85 years of age.
• Subjects must not have a Body Mass Index \>40.
• Subject must have painful diabetic neuropathy (Type 2) present in the lower limbs for more than three months per medical history
• Subject has a pain score ≥5 on VAS at Enrollment/Screening Visit.
• Subject has completed at least one of the two daily pain diary entries on at least five days between the Enrollment/Screening Visit and Visit 1 with a mean pain score of ≥4 and \<10 based on Daily VAS to be eligible for the study.
• Subject is on a stable pain medication regimen or is not taking pain medications, as

You may not qualify if:

• Subjects with neuropathic pain due to post-herpetic neuropathy, HIV, trigeminal neuralgia; subjects whose post- traumatic neuropathic pain is categorized as central (e.g., spinal cord injury) rather than peripheral.
• Subjects with any other chronic or recurrent pain syndrome rated greater than "mild" on a mild-moderate-severe scale, or which the investigator judges may interfere with the patients ability to report their pain accurately.
• Any disorder that may be confused with PDN, such as tarsal tunnel syndrome, sciatica, bunions, ischemic claudication or arthritis of the feet or ankles.
• Subject has a currently diagnosed progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, or severe/critical spinal stenosis (stenosis).
• Subjects with skin conditions in the affected dermatome that in the judgment of the investigator could interfere with evaluation of the neuropathic pain condition.
• Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain; subjects with significant somatic pain at the site of their trauma that may confound assessment or self-evaluation of their neuropathic pain.
• Participation in any other clinical trial within the 30 days prior to screening and/or during participation in this study.
• Any subject considered at risk of suicide or self-harm based on investigator judgment.
• Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality, or other factors that may increase the risk associated with study participation or investigational product administration or may interfere with compliance or the interpretation of study results and, in the judgment of the investigator would make the subject inappropriate to participate in the study.
• Subjects with pending Worker's Compensation, Worker's Compensation, civil litigation, or disability claims. Subjects with fully resolved litigation and compensation claims can participate.
• Subjects who have had a diagnosis of malignancy other than basal cell carcinoma, or carcinoma in situ of the cervix within the past five years, to include life expectancy less than 1 year due to advanced malignancy.
• Subjects with implantable "electrical" medical devices such as a cardiac pacemaker, defibrillator, or insulin pump within four (4) inches or less of the site of pain to be treated by Axon Therapy. (Subject with an implantable device greater than four (4) inches from the site of pain to be treated should NOT be excluded).
• Phantom limb pain or pain that feels like it is coming from a body part that is no longer there.
• Subjects who have failed other neuromodulation implantable device for the same indication
• Subjects with shrapnel or ferromagnetic objects

Sponsors & Collaborators

• NeuraLace Medical, Inc.: lead

Study Sites (7)

Florida Pain Management Associates, P.A.

Sebastian, Florida, 32958, United States

Location

Truwell Health

St. Petersburg, Florida, 33701, United States

Location

Florida Pain Management Associates, P.A.

Vero Beach, Florida, 32960, United States

Location

Centurion Spine and Pain Centers

Brunswick, Georgia, 31520, United States

Location

Centurion Spine and Pain Centers

Waycross, Georgia, 31501, United States

Location

Carolinas Pain Institute and Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

SC Pain and Spine Specialists, LLC

Murrells Inlet, South Carolina, 29576, United States

Location

Related Publications (1)

• Brown L, Gage E, Cordner H, Kapural L, Rosenberg J, Bedder M. Safety and Efficacy of Magnetic Peripheral Nerve Stimulation for Treating Painful Diabetic Neuropathy. Neuromodulation. 2025 Dec;28(8):1366-1373. doi: 10.1016/j.neurom.2025.03.074. Epub 2025 Apr 30.

  PMID: 40304652 DERIVED

MeSH Terms

Conditions

Neuralgia; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Joe Milkovits

  NeuraLace Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Subjects and clinical study staff (with the sole exception of the Blinding Operator) will be blinded to study treatment. Steps for setting up the device are extremely similar whether the patient is in the Sham or Active groups. The following steps must be completed before the patient or the Operator have entered the room for their session. Please avoid any unnecessary interactions with the patient, Operator or any other Clinic personnel in the performance of these tasks. The primary security method for protecting the Blind is strict utilization of Medrio and the special permissions granted by the Sponsor for the conduct of Blinding and Unblinding subjects.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, controlled, double blinded, randomized, multi-center clinical trial in which up to 80 subjects diagnosed with painful diabetic neuropathy will be randomized 3:1 into one of two treatment groups: 1. Axon Therapy plus CMM (AT+CMM) 2. Sham plus CMM (Sham+CMM)

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: December 15, 2022
• Primary Completion: August 23, 2023
• Study Completion: November 22, 2023
• Last Updated: July 11, 2024

Record last verified: 2023-08

Locations

US (7)