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Part A of this trial is a multi-center, prospective, double-blinded, sham-controlled, randomized clinical trial. Part A will evaluate PEMF treatment compared to sham treatment in patients with painful diabetic distal symmetric peripheral neuropathy (DSPN) when treatment is administered 30 minutes twice daily through a 120-day period (4 months). Part B is a 8-month open-label active treatment extension period designed to collect longer-term data on pain, medication use, quality of life and safety (Part B).Part B of this trial is a an extension period upon completion of Part A.
Eligible subjects will be entered into a 14-day ePRO diary run-in period to collect average baseline pain scores related to their diabetic neuropathy in the lower extremities, diary compliance, and analgesic consumption (maintenance and prn prescribed peripheral neuropathic pain medication pill counts). Subjects will collect electronic patient-reported outcome (ePRO) data each morning around the same time during the run-in period.
Subjects will return to the clinic at Baseline (Day 0) for review of eligibility, diary compliance, average baseline diabetic neuropathic pain score of ≥4 and <9, and review of stable analgesic pain consumption profile during the 14-day run-in period. Qualified subjects based on diary compliance and average pain score will be randomized 1:1 (active: sham) and will be instructed to self-treat twice daily for 120 days. Subjects will record electronic patient-reported outcome (ePRO) data following each morning treatment for 120 days. Subjects consenting to distal thigh and distal leg skin biopsies during the Screening visit will have biopsies collected and sent to the central laboratory for assessment. All subjects will have baseline assessments conducted.
Subjects will receive a telephone call at Day 7 to ensure compliance to treatment and diary completion, provide follow-up information on the biopsy sites (if applicable), complete a blinding assessment as well as be assessed for safety and concomitant medication changes.
At Month 1 subjects will return to the clinic for evaluation of safety, concomitant medication changes, review device usage and ePRO diary completion, and Patient Global Impression (PGI). Treatment satisfaction will also be assessed.
At Month 2 subjects will return to the clinic for evaluation of safety, concomitant medication changes, treatment satisfaction, review of device usage (reports will be supplied to the site) and ePRO diary completion, quality of life outcomes (WPAIQ and NeuroQoL), Patient Global Impression (PGI), and interim visit measurements of SPP.
At Month 3, subjects will return to the clinic for evaluation of safety, concomitant medication changes, review device usage (reports will be supplied to the site) and ePRO diary completion, and Patient Global Impression (PGI). Treatment satisfaction will also be assessed.
At Month 4 (end of Part A / start of Part B), subjects will return to the clinic for evaluation of safety, treatment satisfaction, review of device usage (reports will be supplied to the site), HbA1c, concomitant medication changes, weight, quality of life outcomes (WPAIQ and NeuroQoL), PGI, final measurements of SPP, NCS, QST and be assessed to determine their Toronto Clinical Neuropathy Score. Those subjects who consented and had biopsies collected at the Enrollment visit, will have their end of study biopsies during this visit and samples sent directly to the central laboratory for assessment. Subjects will return the study device and complete a blinding assessment.
Subjects that complete Part A will continue into the open-label extension period (Part B). All subjects will be reconsented if not completed at a prior visit and given an open-label active device. Subjects will record ePRO data for one week prior to the Month 6, 8, 10, and 12 visits following each morning treatment. Subjects will be reminded of the150-day (Month 5) phone call.
At Month 5, subjects will receive a telephone call to ensure compliance to treatment, and to be assessed for safety and concomitant medication changes.
At Month 6, subjects will receive a telephone call to ensure treatment compliance and collection of diary data, and to assess safety and concomitant medication changes.
At Month 7, subjects will receive a telephone call to ensure treatment compliance, and to assess safety and concomitant medication changes.
At Month 8, subjects will return to the clinic for evaluation of safety, measure QST, treatment satisfaction, review of device usage and collection of diary data, concomitant medication changes, quality of life outcomes (NeuroQoL), and PGI.
At Month 9, subjects will receive a telephone call to ensure treatment compliance, and to assess safety and concomitant medication changes.
At Month 10, subjects will receive a telephone call to ensure treatment compliance and collection of diary data, and to assess safety and concomitant medication changes.
At Month 11, subjects will receive a telephone call to ensure treatment compliance, and to assess safety and concomitant medication changes.
At Month 12 (end of open-label treatment extension), subjects will return to the clinic for evaluation of safety, weight, QST, NCS, TCNSS, PGI, treatment satisfaction, review of device usage and collection of diary data, concomitant medication changes, quality of life outcomes (NeuroQoL), and will return the study device. Subjects who consented and had biopsies collected at the 4 Month visit, will have their end of study biopsies performed during this visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Group | Experimental | Treatment with active Provant Therapy System |
|
| Sham Group | Sham Comparator | Treatment with in-active (sham) Provant Therapy System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Provant Therapy System | Device | Treatment with active Provant Therapy System |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity | Absolute change in pain intensity as measured by the 11-point, numerical pain rating scale (NPRS) (0-10; where 0=no pain, to 10=worst possible pain). | Baseline through 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With 2 Point or 30% Reduction in Pain at 4 Months | Percentage of patients who have either a 2 point or 30% reduction in (pain) NPRS at 4 Months. Absolute change in pain intensity as measured by the 11-point, numerical pain rating scale (NPRS) (0-10; where 0=no pain, to 10=worst possible pain). | Baseline to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoint: Changes in the Work Productivity and Activity Impairment Questionnaire (WPAIQ) (Questions 2-4) | The Work Productivity and Activity Impairment Questionnaire (WPAIQ) is a validated 6 question assessment tool that measures time missed from work, impairment of work and regular activities due to their health problem. Subjects are asked if they are working (Question 1), and if answer is yes, subjects are asked about the effect their diabetic neuropathy (DN) has on their ability to work and perform regular activities in the past 7 days. Mean change from Baseline to 4-months are displayed below (Questions 2-4) for subjects that responded "Yes" to working in Question 1. Questions 2-4 are answered in number of hours. |
Inclusion Criteria:
To be randomized after the 14-day run-in period, average pain (NPRS) must be ≥ 4 and < 9 over preceding 7 days and subject must be 70% compliant with ePRO assessments (electronic diary)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physician's Research Group | Mesa | Arizona | 85206 | United States | ||
| Valley Clinical Research |
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Protocol Sample Size was anticipated at 170 subjects. The original enrollment target of 170 subjects was exceeded to grant study entry to qualified subjects that completed the 14-day run-in period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Group | Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System |
| FG001 | Sham Group | Treatment with in-active (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with inactive Provant Therapy System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A: Randomized Treatment (17 Weeks) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2018 | Apr 21, 2020 |
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Two parallel groups, active device group versus sham device group. Subjects will be randomized 1:1 at baseline and treat with active PEMF or sham for 4 months.
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Active and sham devices will look identical. Participants and site staff will be blind to the randomization.
| Inactive (sham) Provant Therapy System |
| Device |
Treatment with inactive Provant Therapy System |
|
| Patient Global Impression at 4 Months |
Patient Global Impression at 4 Months. The question assesses change since the start of the study on a 7-point scale ("Since the start of the study, how has your diabetic neuropathy in your legs changed?"), and to score it as either very much worse, much worse, minimally worse, no change, minimally improved, much improved or very much improved. |
| Baseline through 4 months. |
| Time to 30% or 2-point Reduction in NPRS, Whichever Comes First, Through 4 Months | Absolute change in pain intensity as measured by the 11-point, numerical pain rating scale (NPRS) (0-10; where 0=no pain, to 10=worst possible pain). Number of participants achieving a 30% or 2-point reduction at or prior to weeks 1, 4, 8, 12 and 17 are displayed below. | Through 4 months |
| Change in Neuropathy Related Quality of Life (NeuroQoL) Between Baseline and End of Treatment at 4 Months. | A validated set of health-related quality of life measures that are domain specific.Subjects will completed 6 domains: (1) Pain, (2) Lost/Reduced Feeling, (3) Diffuse Sensory Motor Symptoms, (4) Restrictions in Activities of Daily Living, (5) Disruptions in Social Relationships, and (6) Emotional Distress.The short forms were completed by the subject at the Enrollment Visit and end of study visit (Day 121). Each question in the domain was rated on a symptom scale from 1 (never) to 5 (all the time) and a bothersome scale from 1 (none) to 3 (very much). The total score for the domain was calculated by multiplying the symptom score by the bothersome score. The scale range is from 1 to 15 where the minimum (best/least symptomatic) score is 1 and the maximum (worst/most symptomatic) score is 15. The mean change from Baseline to month 4 is displayed below. | Baseline to 4 months |
| Change is Skin Perfusion Pressure (SPP) for Baseline to End of Treatment at 4 Months | SPP was measured at two locations on each foot (dorsal right and left and plantar right and left). Mean change displayed from Baseline to 4-months displayed below. SPP measures pressure in mmHg; an increase in pressure is favorable.
| Baseline to 4 months |
| Changes in Nerve Conduction Studies of Velocity Between Baseline and End of Treatment at 4 Months. | Using the NC-stat DPNCheck, the sural nerve conduction velocity was recorded on the right and left legs. An increase in velocity would suggest DPN improvement. The mean change from Baseline to 4-months is displayed below. | Baseline to 4 Months |
| Changes in Quantitative Sensory Testing (QST) Between Baseline and End of Treatment at 4 Months. | Contact thermal stimulation will be delivered using the Medoc Ltd. Q-Sense system to assess cool sensation threshold, warm sensation threshold and heat pain threshold modalities using the method of limits. Within the cool and warm sensation modalities, the trial is repeated 4 times on each foot and 3 times on each foot for heat pain threshold modality. The cool thermal testing will be conducted prior to the warm and heat pain thermal testing. Mean change from baseline to 4-months displayed below. | Baseline to 4 months |
| Changes in Nerve Conduction Studies of Amplitude Between Baseline and End of Treatment at 4 Months. | Using the NC-stat DPNCheck, the sural nerve conduction amplitude was recorded on the right and left legs. An increase in amplitude would suggest DPN improvement. The mean change from Baseline to 4-months is displayed below. | Baseline to 4 Months |
| Baseline to 4 Months |
| Exploratory Endpoint: Changes in Intraepidermal Nerve Fiber Density (IENFD) at the Distal Thigh and Distal Leg - Part A | Optional two 3 mm punch skin biopsies will be performed at baseline and end of treatment to assess IENFD. At the Enrollment Visit, one biopsy will be obtained at the distal leg, 10 cm above the lateral malleolus on the right leg and a second biopsy will be obtained at the distal thigh, 10 cm above the superior margin of the patella on the lateral right leg. At the end of Part A study visit Month 4 (Day 121), a second set of biopsies will be obtained lateral to the baseline biopsies and shipped overnight to the central lab. For Active Group and Sham Group displayed below, result are the change in nerve fiber density from Baseline to Month 4. | Baseline to Month 4 |
| Exploratory Endpoint: Change in Pain Intensity During Part B | Absolute change in pain intensity as measured by the 11-point, numerical pain rating scale (NPRS) (0-10; where 0=no pain, to 10=worst possible pain). Results below display the change from Baseline to Month 12 for subjects that participated in the open-label extension (Part B), stratified by their original randomization in Part A. | Baseline through 12 months |
| Exploratory Endpoint: Changes in Nerve Conduction Studies of Velocity During Part B | Using the NC-stat DPNCheck, the sural nerve conduction velocity was recorded on the right and left legs. An increase in velocity would suggest DPN improvement. Results below display the mean change in velocity and from Baseline to Month 12 for subjects that participated in the open-label extension (Part B), stratified by their original randomization in Part A. | Baseline to Month 12 |
| Exploratory Endpoint: Change in Neuropathy Related Quality of Life (NeuroQoL) During Part B | A validated set of health-related quality of life measures that are domain specific.Subjects will completed 6 domains: (1)Pain, (2)Lost/Reduced Feeling, (3)Diffuse Sensory Motor Symptoms, (4)Restrictions in Activities of Daily Living, (5)Disruptions in Social Relationships, and (6)Emotional Distress.The short forms were completed by the subject at the Enrollment Visit, end of study visit (Day 121) and at 12 months. Each question in the domain was rated on a symptom scale from 1 (never) to 5 (all the time) and a bothersome scale from 1 (none) to 3 (very much). The total score for the domain was calculated by multiplying the symptom score by the bothersome score. The scale range is from 1 to 15 where the minimum (best/least symptomatic) score is 1 and the maximum (worst/most symptomatic) score is 15. Results below display the change from Baseline to Month 12 for subjects that participated in the open-label extension (Part B), stratified by their original randomization in Part | Baseline to Month 12 |
| Exploratory Endpoint: Changes in Nerve Conduction Studies of Amplitude During Part B | Using the NC-stat DPNCheck, the sural nerve conduction amplitude was recorded on the right and left legs. An increase in amplitude would suggest DPN improvement. Results below display the mean change in amplitude from Baseline to Month 12 for subjects that participated in the open-label extension (Part B), stratified by their original randomization in Part A. | Baseline to Month 12 |
| Exploratory Endpoint: Changes in the Work Productivity and Activity Impairment Questionnaire (WPAIQ) (Questions 5-6) | The Work Productivity and Activity Impairment Questionnaire (WPAIQ) is a validated 6 question assessment tool that measures time missed from work, impairment of work and regular activities due to their health problem. Subjects are asked if they are working (Question 1), and if answer is yes, subjects are asked about the effect their diabetic neuropathy (DN) has on their ability to work and perform regular activities in the past 7 days. Mean change from Baseline to 4-months displayed below (Questions 5-6) for subjects that responded "Yes" to working in Question 1. Questions 5 and 6 use a 0-10 scale where 0 = no effect on work and/or daily activities and 10 =DN completely prevented me from working and/or doing daily activities. | Baseline to 4 Months |
| Exploratory Endpoint: Changes in Intraepidermal Nerve Fiber Density (IENFD) at the Distal Thigh and Distal Leg - Part B | Optional two 3 mm punch skin biopsies will be performed at baseline and end of treatment to assess IENFD. At the Enrollment Visit, one biopsy will be obtained at the distal leg, 10 cm above the lateral malleolus on the right leg and a second biopsy will be obtained at the distal thigh, 10 cm above the superior margin of the patella on the lateral right leg. At the end of Part A study visit Month 4 (Day 121), a second set of biopsies will be obtained lateral to the baseline biopsies and shipped overnight to the central lab. At the end of Part B study visit Month 12 (Day 361), a final set of biopsies will be obtained lateral to the Month 4 biopsies. Results displayed are the change in nerve fiber density from Baseline to Month 12 for subjects that participated in the open-label extension (Part B), stratified by their original randomization in Part A. | Baseline to Month 12 |
| Northridge |
| California |
| 91325 |
| United States |
| Northern California Research | Sacramento | California | 95821 | United States |
| Diabetes Research Center | Tustin | California | 92780 | United States |
| Mountain View Clinical Research | Denver | Colorado | 80209 | United States |
| Lake Internal Medicine Associates | Eustis | Florida | 32726 | United States |
| Clinical Physiology Associates | Fort Myers | Florida | 33912 | United States |
| Spotlight Research Center | Miami | Florida | 33176 | United States |
| Clinical Research of Central Florida | Winter Haven | Florida | 33880 | United States |
| River Birch Research Alliance, LLC | Blue Ridge | Georgia | 30514 | United States |
| MediSphere Medical Research Center, LLC | Evansville | Indiana | 47714 | United States |
| Heartland Research Associate, LLC | Wichita | Kansas | 67207 | United States |
| Healthcare Research Network | Hazelwood | Missouri | 63042 | United States |
| The Center for Pharmaceutical Research, LLC | Kansas City | Missouri | 64114 | United States |
| Palm Research Center | Las Vegas | Nevada | 89128 | United States |
| Great Lakes Medical Resarch | Westfield | New York | 14787 | United States |
| Wake Family Medicine, PC | Cary | North Carolina | 27513 | United States |
| Rainier Clinical Research | Renton | Washington | 98057 | United States |
| FG002 | Open-label Extension Group (Part B) | Subjects receiving open-label active PEMF therapy in Part B after 17 weeks of randomized treatment in Part A. |
| COMPLETED |
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| NOT COMPLETED |
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|
| Part B: Open-label Extension (24 Weeks) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Group | Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System |
| BG001 | Sham Group | Treatment with in-active (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with inactive Provant Therapy System |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Intensity | Absolute change in pain intensity as measured by the 11-point, numerical pain rating scale (NPRS) (0-10; where 0=no pain, to 10=worst possible pain). | Posted | Mean | Standard Deviation | units on a scale | Baseline through 4 months |
|
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| Secondary | Patients With 2 Point or 30% Reduction in Pain at 4 Months | Percentage of patients who have either a 2 point or 30% reduction in (pain) NPRS at 4 Months. Absolute change in pain intensity as measured by the 11-point, numerical pain rating scale (NPRS) (0-10; where 0=no pain, to 10=worst possible pain). | Posted | Count of Participants | Participants | Baseline to 4 months |
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| Secondary | Patient Global Impression at 4 Months | Patient Global Impression at 4 Months. The question assesses change since the start of the study on a 7-point scale ("Since the start of the study, how has your diabetic neuropathy in your legs changed?"), and to score it as either very much worse, much worse, minimally worse, no change, minimally improved, much improved or very much improved. | Posted | Count of Participants | Participants | Baseline through 4 months. |
|
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| Secondary | Time to 30% or 2-point Reduction in NPRS, Whichever Comes First, Through 4 Months | Absolute change in pain intensity as measured by the 11-point, numerical pain rating scale (NPRS) (0-10; where 0=no pain, to 10=worst possible pain). Number of participants achieving a 30% or 2-point reduction at or prior to weeks 1, 4, 8, 12 and 17 are displayed below. | Posted | Count of Participants | Participants | Through 4 months |
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| Secondary | Change in Neuropathy Related Quality of Life (NeuroQoL) Between Baseline and End of Treatment at 4 Months. | A validated set of health-related quality of life measures that are domain specific.Subjects will completed 6 domains: (1) Pain, (2) Lost/Reduced Feeling, (3) Diffuse Sensory Motor Symptoms, (4) Restrictions in Activities of Daily Living, (5) Disruptions in Social Relationships, and (6) Emotional Distress.The short forms were completed by the subject at the Enrollment Visit and end of study visit (Day 121). Each question in the domain was rated on a symptom scale from 1 (never) to 5 (all the time) and a bothersome scale from 1 (none) to 3 (very much). The total score for the domain was calculated by multiplying the symptom score by the bothersome score. The scale range is from 1 to 15 where the minimum (best/least symptomatic) score is 1 and the maximum (worst/most symptomatic) score is 15. The mean change from Baseline to month 4 is displayed below. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 4 months |
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| Secondary | Change is Skin Perfusion Pressure (SPP) for Baseline to End of Treatment at 4 Months | SPP was measured at two locations on each foot (dorsal right and left and plantar right and left). Mean change displayed from Baseline to 4-months displayed below. SPP measures pressure in mmHg; an increase in pressure is favorable.
| Posted | Mean | Standard Deviation | mmHg | Baseline to 4 months |
|
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| Secondary | Changes in Nerve Conduction Studies of Velocity Between Baseline and End of Treatment at 4 Months. | Using the NC-stat DPNCheck, the sural nerve conduction velocity was recorded on the right and left legs. An increase in velocity would suggest DPN improvement. The mean change from Baseline to 4-months is displayed below. | Posted | Mean | Standard Deviation | m/s (velocity) | Baseline to 4 Months |
|
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| Secondary | Changes in Quantitative Sensory Testing (QST) Between Baseline and End of Treatment at 4 Months. | Contact thermal stimulation will be delivered using the Medoc Ltd. Q-Sense system to assess cool sensation threshold, warm sensation threshold and heat pain threshold modalities using the method of limits. Within the cool and warm sensation modalities, the trial is repeated 4 times on each foot and 3 times on each foot for heat pain threshold modality. The cool thermal testing will be conducted prior to the warm and heat pain thermal testing. Mean change from baseline to 4-months displayed below. | Posted | Mean | Standard Deviation | Temperature in degrees C | Baseline to 4 months |
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| Other Pre-specified | Exploratory Endpoint: Changes in the Work Productivity and Activity Impairment Questionnaire (WPAIQ) (Questions 2-4) | The Work Productivity and Activity Impairment Questionnaire (WPAIQ) is a validated 6 question assessment tool that measures time missed from work, impairment of work and regular activities due to their health problem. Subjects are asked if they are working (Question 1), and if answer is yes, subjects are asked about the effect their diabetic neuropathy (DN) has on their ability to work and perform regular activities in the past 7 days. Mean change from Baseline to 4-months are displayed below (Questions 2-4) for subjects that responded "Yes" to working in Question 1. Questions 2-4 are answered in number of hours. | Includes only subjects that indicated they were working at the Enrollment Visit (Question 1). | Posted | Mean | Standard Deviation | Hours | Baseline to 4 Months |
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| Other Pre-specified | Exploratory Endpoint: Changes in Intraepidermal Nerve Fiber Density (IENFD) at the Distal Thigh and Distal Leg - Part A | Optional two 3 mm punch skin biopsies will be performed at baseline and end of treatment to assess IENFD. At the Enrollment Visit, one biopsy will be obtained at the distal leg, 10 cm above the lateral malleolus on the right leg and a second biopsy will be obtained at the distal thigh, 10 cm above the superior margin of the patella on the lateral right leg. At the end of Part A study visit Month 4 (Day 121), a second set of biopsies will be obtained lateral to the baseline biopsies and shipped overnight to the central lab. For Active Group and Sham Group displayed below, result are the change in nerve fiber density from Baseline to Month 4. | Posted | Mean | Standard Deviation | nerve fiber density in fibers/mm | Baseline to Month 4 |
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| Other Pre-specified | Exploratory Endpoint: Change in Pain Intensity During Part B | Absolute change in pain intensity as measured by the 11-point, numerical pain rating scale (NPRS) (0-10; where 0=no pain, to 10=worst possible pain). Results below display the change from Baseline to Month 12 for subjects that participated in the open-label extension (Part B), stratified by their original randomization in Part A. | Posted | Mean | Standard Deviation | units on a scale | Baseline through 12 months |
|
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| Other Pre-specified | Exploratory Endpoint: Changes in Nerve Conduction Studies of Velocity During Part B | Using the NC-stat DPNCheck, the sural nerve conduction velocity was recorded on the right and left legs. An increase in velocity would suggest DPN improvement. Results below display the mean change in velocity and from Baseline to Month 12 for subjects that participated in the open-label extension (Part B), stratified by their original randomization in Part A. | Posted | Mean | Standard Deviation | m/s (velocity) | Baseline to Month 12 |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory Endpoint: Change in Neuropathy Related Quality of Life (NeuroQoL) During Part B | A validated set of health-related quality of life measures that are domain specific.Subjects will completed 6 domains: (1)Pain, (2)Lost/Reduced Feeling, (3)Diffuse Sensory Motor Symptoms, (4)Restrictions in Activities of Daily Living, (5)Disruptions in Social Relationships, and (6)Emotional Distress.The short forms were completed by the subject at the Enrollment Visit, end of study visit (Day 121) and at 12 months. Each question in the domain was rated on a symptom scale from 1 (never) to 5 (all the time) and a bothersome scale from 1 (none) to 3 (very much). The total score for the domain was calculated by multiplying the symptom score by the bothersome score. The scale range is from 1 to 15 where the minimum (best/least symptomatic) score is 1 and the maximum (worst/most symptomatic) score is 15. Results below display the change from Baseline to Month 12 for subjects that participated in the open-label extension (Part B), stratified by their original randomization in Part | Posted | Mean | Standard Deviation | units on a scale | Baseline to Month 12 |
| |||||||||||||||||||||||||||||||
| Secondary | Changes in Nerve Conduction Studies of Amplitude Between Baseline and End of Treatment at 4 Months. | Using the NC-stat DPNCheck, the sural nerve conduction amplitude was recorded on the right and left legs. An increase in amplitude would suggest DPN improvement. The mean change from Baseline to 4-months is displayed below. | Posted | Mean | Standard Deviation | uv (amplitude) | Baseline to 4 Months |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory Endpoint: Changes in Nerve Conduction Studies of Amplitude During Part B | Using the NC-stat DPNCheck, the sural nerve conduction amplitude was recorded on the right and left legs. An increase in amplitude would suggest DPN improvement. Results below display the mean change in amplitude from Baseline to Month 12 for subjects that participated in the open-label extension (Part B), stratified by their original randomization in Part A. | Posted | Mean | Standard Deviation | uv (amplitude) and m/s (velocity) | Baseline to Month 12 |
|
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| Other Pre-specified | Exploratory Endpoint: Changes in the Work Productivity and Activity Impairment Questionnaire (WPAIQ) (Questions 5-6) | The Work Productivity and Activity Impairment Questionnaire (WPAIQ) is a validated 6 question assessment tool that measures time missed from work, impairment of work and regular activities due to their health problem. Subjects are asked if they are working (Question 1), and if answer is yes, subjects are asked about the effect their diabetic neuropathy (DN) has on their ability to work and perform regular activities in the past 7 days. Mean change from Baseline to 4-months displayed below (Questions 5-6) for subjects that responded "Yes" to working in Question 1. Questions 5 and 6 use a 0-10 scale where 0 = no effect on work and/or daily activities and 10 =DN completely prevented me from working and/or doing daily activities. | Includes only subjects that indicated they were working at the Enrollment Visit (Question 1). | Posted | Mean | Standard Deviation | units on a scale | Baseline to 4 Months |
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory Endpoint: Changes in Intraepidermal Nerve Fiber Density (IENFD) at the Distal Thigh and Distal Leg - Part B | Optional two 3 mm punch skin biopsies will be performed at baseline and end of treatment to assess IENFD. At the Enrollment Visit, one biopsy will be obtained at the distal leg, 10 cm above the lateral malleolus on the right leg and a second biopsy will be obtained at the distal thigh, 10 cm above the superior margin of the patella on the lateral right leg. At the end of Part A study visit Month 4 (Day 121), a second set of biopsies will be obtained lateral to the baseline biopsies and shipped overnight to the central lab. At the end of Part B study visit Month 12 (Day 361), a final set of biopsies will be obtained lateral to the Month 4 biopsies. Results displayed are the change in nerve fiber density from Baseline to Month 12 for subjects that participated in the open-label extension (Part B), stratified by their original randomization in Part A. | Posted | Mean | Standard Deviation | nerve fiber density in fibers/mm | Baseline to Month 12 |
|
|
Part A: 4 months (Baseline to Month 4); Part B: 8 months (Month 4 to Month 12)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Group (Part A) | Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System | 0 | 92 | 5 | 92 | 0 | 92 |
| EG001 | Sham Group (Part A) | Treatment with in-active (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with inactive Provant Therapy System | 0 | 90 | 6 | 90 | 0 | 90 |
| EG002 | Open-label Extension Group (Part B) | Treatment with open-label active Provant Therapy System during Part B (months 4-12) | 57 | 152 | 5 | 152 | 0 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment | Pancreatitis |
| |
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment | Dehydration |
| |
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment | Congestive heart failure |
| |
| Peripheral vascular disorder | Vascular disorders | Systematic Assessment | peripheral vascular disease NOS |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | COPD exacerbation |
| |
| Subdural heamatoma | Injury, poisoning and procedural complications | Systematic Assessment | Hematoma subdural |
| |
| seizure | Nervous system disorders | Systematic Assessment | Seizures |
| |
| Sepsis | Infections and infestations | Systematic Assessment | Sepsis |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | adenocarcinoma gastric |
| |
| pneumonia | Infections and infestations | Systematic Assessment | pneumonia |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment | Infusion related reaction |
| |
| abdominal pain upper | Gastrointestinal disorders | Systematic Assessment | right upper quadrant pain |
| |
| rib fracture | Injury, poisoning and procedural complications | Systematic Assessment | rib fracture |
| |
| Goitre | Endocrine disorders | Systematic Assessment | Goitre |
| |
| Diverticulum | Gastrointestinal disorders | Systematic Assessment | Diverticulum |
| |
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment | Small intestinal obstruction |
| |
| Chest pain | General disorders | Systematic Assessment | Chest pain |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Malignant melanoma in situ |
| |
| Ischaemic stroke | Nervous system disorders | Systematic Assessment | Ischaemic stroke |
|
Not provided
Publication Rights. Independent analysis and/or publication of data generated or arising from the performance of this Agreement is not permitted without the prior written consent of Regenesis. Such consent may be contingent on Regenesis' review and approval of any proposed analysis and manuscript. Institution will retain the right to review and analyze the database created from this study for its own scientific purposes so long as such scientific purposes are non-commercial in nature.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Vander Ploeg | Regenesis Biomedical | 602-428-7041 | heather.vanderploeg@regenesisbio.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2018 | Apr 21, 2020 | SAP_002.pdf |
| Lack of Efficacy |
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| Lost to Follow-up |
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| Out of window for visits |
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| Device interfered with home speakers |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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