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

Primary Purpose

Neuralgia, Neuropathic Pain, Painful Diabetic Neuropathy

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Axon Therapy and CMM
Sham and CMM
Sponsored by
NeuraLace Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia focused on measuring transcutaneous magnetic stimulation, axon therapy, peripheral neuropathic pain, diabetic neuropathy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 Subject is currently taking a morphine equivalent daily dose > 120 mg/day. Subject is a woman of childbearing potential, not using adequate contraception or not willing to comply with contraception for the duration of the study. Subjects with active drug or alcohol abuse within 1 year prior to screening. Subjects with hemoglobin A1C of 9% or higher for 90 days prior to screening.

Sites / Locations

  • Truwell Health
  • Florida Pain Management Associates, P.A.
  • Florida Pain Management Associates, P.A.
  • Centurion Spine and Pain Centers
  • Centurion Spine and Pain Centers
  • Carolinas Pain Institute and Center for Clinical Research
  • SC Pain and Spine Specialists, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Axon Therapy + CMM

Sham + CMM

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Comparison of the Proportion of Responders
The primary efficacy endpoint is a between groups comparison of pain change from baseline to 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.

Secondary Outcome Measures

Visual Analog Scale (VAS) for Pain
Scores from daily diaries will be compared to baseline overall and by group (Axon therapy (AT) plus CMM and AT crossover (ATx) plus CMM)
VAS for Numbness
Scores from daily diaries will be compared to baseline overall and by group (AT + CMM and ATx + CMM)
Brief Pain Inventory (BPI)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Daily Sleep Interference Scale (DSIS)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
EQ-5D-3L
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Patient Global Impression of Change (PGIC)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM). In addition, the proportion of subjects with a minimal clinically important change from baseline will be compared between groups.
Depression Anxiety Stress Scales (DASS)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Pain Disability Index (PDI)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM). In addition, the proportion of subjects with a minimal clinically important change from baseline will be compared between groups.
Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) Questionnaire
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
In-clinic VAS Pain Scores
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Increase from baseline pain medication within four weeks of the Day 90 visit (based on prescribed doses)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Proportion of subjects who discontinue treatment
Proportion of subjects who discontinue treatment will be compared between groups
Neurological Exam - percentage of treatment arm with a change in neurological status
Percentage of treatment arm (including crossover subjects) with a change in neurological status as determined by neurological exam on Day 90 after start of active treatment.

Full Information

First Posted
November 9, 2022
Last Updated
August 28, 2023
Sponsor
NeuraLace Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05620225
Brief Title
Axon Therapy and Conventional Medical Management for Painful Diabetic Neuropathy Compared to Sham and Conventional Medical Management
Official Title
A Multicenter, Randomized, Clinical Trial Comparing the Safety and Effectiveness of Axon Therapy and Conventional Medical Management (AT+CMM) for the Treatment of Painful Diabetic Neuropathy to Sham and Conventional Medical Management (Sham+CMM)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
August 23, 2023 (Actual)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuraLace Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
This is a two-phase study. Phase 1 is a double blinded, two-arm, randomized, multi-center clinical trial to assess 1-month efficacy as compared to a sham group. Up to approximately 80 subjects diagnosed with painful diabetic neuropathy will be randomized 3:1 into one of two treatment groups: Axon Therapy plus CMM (AT+CMM) Sham plus CMM (Sham+CMM) 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. Phase 2 of the study is an unblinded, one-arm, multi-center trial to assess extended efficacy of the treatment. At Day 30, subjects will be unblinded and allowed to remain in the study for an additional 60 (AT+CMM) to 90 (ATx+CMM) days. Those in the Sham arm can choose to crossover to active treatment ( ATx+CMM). Subjects in the AT+CMM arm will return to the clinic as follows: Month 2: Bi-weekly treatment Month 3: Treatments every 2-4 weeks Additional treatments to treat flare ups; defined as an episode of pain with a VAS 6. Subjects in the ATx+CMM arm will return to the clinic as follows: Month 2: 6 treatments Week 1: 3 treatments Week 2-4: Weekly treatments Month 3: Bi-weekly treatment Month 4: Treatments every 2-4 weeks Additional treatments to treat flare ups; defined as an episode of pain with a VAS 6. Subjects who do not choose to remain in the study will be monitored for 30 days for AEs and then they will exit the study. The subject's reason for exiting the study will be recorded. In addition to in-clinic assessments and treatments, all subjects will complete an electronic twice daily diary through Day 30 of the study (Day 60 for ATx+CMM subjects). Subjects will receive weekly phone follow-up for diary reminders and to assess for the occurrence of adverse events. Weekly phone follow-up will occur only during weeks when the subject is not seen in the clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Neuropathic Pain, Painful Diabetic Neuropathy
Keywords
transcutaneous magnetic stimulation, axon therapy, peripheral neuropathic pain, diabetic neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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: Axon Therapy plus CMM (AT+CMM) Sham plus CMM (Sham+CMM)
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Axon Therapy + CMM
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham + CMM
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Axon Therapy and CMM
Intervention Description
transcutaneous magnetic stimulation (TMS)
Intervention Type
Device
Intervention Name(s)
Sham and CMM
Intervention Description
Sham and CMM
Primary Outcome Measure Information:
Title
Comparison of the Proportion of Responders
Description
The primary efficacy endpoint is a between groups comparison of pain change from baseline to 30 days.
Time Frame
30 days
Title
Comparison of therapy-related AEs between the 2 Study arms
Description
The primary safety endpoint for this study is a comparison of therapy-related AEs through Day 30 between the 2 arms of the Study.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS) for Pain
Description
Scores from daily diaries will be compared to baseline overall and by group (Axon therapy (AT) plus CMM and AT crossover (ATx) plus CMM)
Time Frame
30- and 90-days post-treatment
Title
VAS for Numbness
Description
Scores from daily diaries will be compared to baseline overall and by group (AT + CMM and ATx + CMM)
Time Frame
30- and 90-days post-treatment
Title
Brief Pain Inventory (BPI)
Description
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Time Frame
30- and 90-days post-treatment
Title
Daily Sleep Interference Scale (DSIS)
Description
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Time Frame
30- and 90-days post-treatment
Title
EQ-5D-3L
Description
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Time Frame
30- and 90-days post-treatment
Title
Patient Global Impression of Change (PGIC)
Description
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM). In addition, the proportion of subjects with a minimal clinically important change from baseline will be compared between groups.
Time Frame
30- and 90-days post-treatment
Title
Depression Anxiety Stress Scales (DASS)
Description
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Time Frame
30- and 90-days post-treatment
Title
Pain Disability Index (PDI)
Description
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM). In addition, the proportion of subjects with a minimal clinically important change from baseline will be compared between groups.
Time Frame
30- and 90-days post-treatment
Title
Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) Questionnaire
Description
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Time Frame
30- and 90-days post-treatment
Title
In-clinic VAS Pain Scores
Description
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Time Frame
30- and 90-days post-treatment
Title
Increase from baseline pain medication within four weeks of the Day 90 visit (based on prescribed doses)
Description
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Time Frame
30- and 90-days post-treatment
Title
Proportion of subjects who discontinue treatment
Description
Proportion of subjects who discontinue treatment will be compared between groups
Time Frame
30- and 90-days post-treatment
Title
Neurological Exam - percentage of treatment arm with a change in neurological status
Description
Percentage of treatment arm (including crossover subjects) with a change in neurological status as determined by neurological exam on Day 90 after start of active treatment.
Time Frame
90 days post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Subject is currently taking a morphine equivalent daily dose > 120 mg/day. Subject is a woman of childbearing potential, not using adequate contraception or not willing to comply with contraception for the duration of the study. Subjects with active drug or alcohol abuse within 1 year prior to screening. Subjects with hemoglobin A1C of 9% or higher for 90 days prior to screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe Milkovits
Organizational Affiliation
NeuraLace Medical
Official's Role
Study Director
Facility Information:
Facility Name
Truwell Health
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Florida Pain Management Associates, P.A.
City
Sebastian
State/Province
Florida
ZIP/Postal Code
32958
Country
United States
Facility Name
Florida Pain Management Associates, P.A.
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Centurion Spine and Pain Centers
City
Brunswick
State/Province
Georgia
ZIP/Postal Code
31520
Country
United States
Facility Name
Centurion Spine and Pain Centers
City
Waycross
State/Province
Georgia
ZIP/Postal Code
31501
Country
United States
Facility Name
Carolinas Pain Institute and Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
SC Pain and Spine Specialists, LLC
City
Murrells Inlet
State/Province
South Carolina
ZIP/Postal Code
29576
Country
United States

12. IPD Sharing Statement

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

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