An interventional study of Active Provant Therapy System and Inactive (sham) Provant Therapy System in Diabetic Neuropathy Peripheral, sponsored by Regenesis Biomedical, Inc.. Completed at 18 sites in United States. Open to participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by Regenesis Biomedical, Inc. · Not applicable, Interventional, and Treatment
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.
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:
Treatment with active Provant Therapy System
Device: Active Provant Therapy System
Treatment with in-active (sham) Provant Therapy System
Device: Inactive (sham) Provant Therapy System
Treatment with active Provant Therapy System
Treatment with inactive Provant Therapy System
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).
Time frame: Baseline through 4 months
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).
Time frame: Baseline to 4 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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. * Normal SPP: 50 mmHg to 100 mmHg * Marginal Ischemia SPP: 30 mmHg to 50 mmHg * Critical Limb Ischemia / PAD SPP: \< 30 mmHg
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 4 Months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Month 12
| Milestone | Active Group | Sham Group | Open-label Extension Group (Part B) |
|---|---|---|---|
| Started | 92 | 90 | 0 |
| Completed | 81 | 83 | 0 |
| Not completed | 11 | 7 | 0 |
| Withdrew: Adverse event | 2 | 5 | 0 |
| Withdrew: Withdrawal by subject | 7 | 2 | 0 |
| Withdrew: Physician decision | 2 | 0 | 0 |
| Milestone | Active Group | Sham Group | Open-label Extension Group (Part B) |
|---|---|---|---|
| Started | 0 | 0 | 152 |
| Completed | 0 | 0 | 115 |
| Not completed | 0 | 0 | 37 |
| Withdrew: Adverse event | 0 | 0 | 3 |
| Withdrew: Withdrawal by subject | 0 | 0 | 20 |
| Withdrew: Lack of efficacy | 0 | 0 | 7 |
| Withdrew: Lost to follow-up | 0 | 0 | 4 |
| Withdrew: Out of window for visits | 0 | 0 | 2 |
| Withdrew: Device interfered with home speakers | 0 | 0 | 1 |
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).
| units on a scale | Active Group | Sham Group |
|---|---|---|
| Change in Pain Intensity | -1.47 ± 1.845 | -1.25 ± 2.018 |
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).
| Participants | Active Group | Sham Group |
|---|---|---|
| Patients With 2 Point or 30% Reduction in Pain at 4 Months | 28 | 26 |
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.
| Participants | Active Group | Sham Group |
|---|---|---|
| Much Worse | 1 | 2 |
| Minimally Worse | 3 | 11 |
| No Change | 24 | 28 |
| Minimally Improved | 37 | 23 |
| Much Improved | 16 | 20 |
| Very Much Improved | 3 | 3 |
| Not reported | 8 | 3 |
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.
| Participants | Active Group | Sham Group |
|---|---|---|
| Week 1 | 4 | 3 |
| Week 4 | 18 | 18 |
| Week 8 | 32 | 27 |
| Week 12 | 43 | 34 |
| Week 17 | 45 | 40 |
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.
| units on a scale | Active Group | Sham Group |
|---|---|---|
| (1) Pain | -1.66 (-2.22 to -1.11) | -1.52 (-2.13 to -0.91) |
| (2) Lost/Reduced Feeling | -1.03 (-1.67 to -0.40) | -1.42 (-2.16 to -0.68) |
| (3) Diffuse Sensory Motor Symptoms | -0.92 (-1.53 to -0.30) | -0.79 (-1.48 to -0.09) |
| (4) Restrictions in Activities of Daily Living | -1.66 (-2.38 to -0.93) | -2.38 (-3.16 to -1.60) |
| (5) Disruptions in Social Relationships | -1.31 (-1.99 to -0.62) | -1.99 (-2.70 to -1.29) |
| (6) Emotional Distress | -1.12 (-1.68 to -0.55) | -1.63 (-2.33 to -0.93) |
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. * Normal SPP: 50 mmHg to 100 mmHg * Marginal Ischemia SPP: 30 mmHg to 50 mmHg * Critical Limb Ischemia / PAD SPP: \< 30 mmHg
| mmHg | Active Group | Sham Group |
|---|---|---|
| Dorsal - Left | -0.25 ± 34.22 | 3.27 ± 33.82 |
| Dorsal - Right | -0.74 ± 35.18 | 2.93 ± 25.83 |
| Plantar - Left | 6.37 ± 27.72 | -1.84 ± 28.87 |
| Plantar - Right | 2.12 ± 21.05 | -2.51 ± 23.66 |
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.
| m/s (velocity) | Active Group | Sham Group |
|---|---|---|
| Velocity (uv) - Left | -4.15 ± 20.45 | -5.12 ± 22.25 |
| Velocity (uv) - Right | -1.11 ± 18.18 | -5.06 ± 20.94 |
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.
| Temperature in degrees C | Active Group | Sham Group |
|---|---|---|
| Cold - Right | 0.57 ± 3.32 | -0.21 ± 3.07 |
| Cold - Left | 0.08 ± 3.25 | 0.02 ± 2.85 |
| Warm - Right | -0.58 ± 3.70 | -0.54 ± 4.07 |
| Warm - Left | -0.53 ± 4.25 | 0.01 ± 4.41 |
| Pain - Right | -0.29 ± 3.21 | -0.75 ± 3.10 |
| Pain - Left | -0.62 ± 3.23 | -0.23 ± 2.97 |
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.
| Hours | Active Group | Sham Group |
|---|---|---|
| Work hours missed in past 7 days due to DN | 0.12 ± 2.96 | 0.33 ± 1.89 |
| Work hours missed in past 7 days not due to DN | 0.60 ± 9.17 | 2.61 ± 9.38 |
| Hours worked in past 7 days | -0.48 ± 10.62 | -2.11 ± 20.80 |
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.
| nerve fiber density in fibers/mm | Active Group | Sham Group |
|---|---|---|
| Right Distal Leg | -0.12 ± 1.60 | 0.73 ± 2.33 |
| Right Distal Thigh | 0.64 ± 2.93 | 1.68 ± 2.63 |
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.
| units on a scale | Active Group | Sham Group |
|---|---|---|
| Exploratory Endpoint: Change in Pain Intensity During Part B | -2.96 ± 2.38 | 2.49 ± 2.38 |
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.
| m/s (velocity) | Active Group | Sham Group |
|---|---|---|
| Velocity (m/s) - Left | -11.9 ± 26.0 | -8.64 ± 24.7 |
| Velocity (m/s) - Right | -9.48 ± 19.5 | -6.31 ± 22.9 |
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
| units on a scale | Active Group | Sham Group |
|---|---|---|
| (1) Pain | -3.14 ± 2.33 | -2.88 ± 3.19 |
| (2) Lost/Reduced Feeling | -2.42 ± 2.99 | -1.96 ± 4.07 |
| (3) Diffuse Sensory Motor | -1.58 ± 2.78 | -1.04 ± 3.41 |
| (4) Restrictions in Activities | -2.67 ± 3.61 | -2.14 ± 4.85 |
| (5) Distruptions in Social Relationships | -2.25 ± 3.73 | -1.73 ± 3.96 |
| (6) Emotional Distress | -1.60 ± 3.81 | -1.79 ± 3.58 |
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.
| uv (amplitude) | Active Group | Sham Group |
|---|---|---|
| Amplitude (m/s) - Left | 1.27 ± 9.96 | 1.36 ± 11.63 |
| Amplitude (m/s) - Right | 1.95 ± 10.27 | 1.03 ± 9.91 |
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.
| uv (amplitude) and m/s (velocity) | Active Group | Sham Group |
|---|---|---|
| Amplitude (uv) - Left | 5.28 ± 14.4 | 4.42 ± 14.6 |
| Amplitude (uv) - Right | 6.0 ± 15.3 | 4.28 ± 14.2 |
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.
| units on a scale | Active Group | Sham Group |
|---|---|---|
| Effect of DN on work in past 7 days | -0.40 ± 1.89 | -0.61 ± 3.01 |
| Effect on daily activities in past 7 days | -0.67 ± 2.19 | -0.59 ± 2.70 |
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.
| nerve fiber density in fibers/mm | Open-label Extension Group (Part B) |
|---|---|
| Right Distal Leg | .22 ± 2.17 |
| Right Distal Thigh | 1.09 ± 2.94 |
Collected over Part A: 4 months (Baseline to Month 4); Part B: 8 months (Month 4 to Month 12). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Group (Part A) | 0/92 (0%) | 5/92 (5.4%) | 0/92 (0%) |
| Sham Group (Part A) | 0/90 (0%) | 6/90 (6.7%) | 0/90 (0%) |
| Open-label Extension Group (Part B) | 57/152 (37.5%) | 5/152 (3.3%) | 0/152 (0%) |
| Event | Active Group (Part A) | Sham Group (Part A) | Open-label Extension Group (Part B) |
|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 1/92 | 1/90 | 0/152 |
| Subdural heamatomaInjury, poisoning and procedural complications | 0/92 | 1/90 | 0/152 |
| seizureNervous system disorders | 0/92 | 1/90 | 0/152 |
| SepsisInfections and infestations | 0/92 | 1/90 | 0/152 |
| Adenocarcinoma gastricNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/92 | 1/90 | 0/152 |
| pneumoniaInfections and infestations | 0/92 | 1/90 | 0/152 |
| Infusion related reactionInjury, poisoning and procedural complications | 0/92 | 1/90 | 0/152 |
| abdominal pain upperGastrointestinal disorders | 0/92 | 1/90 | 0/152 |
| rib fractureInjury, poisoning and procedural complications | 0/92 | 1/90 | 0/152 |
| PancreatitisGastrointestinal disorders | 1/92 | 0/90 | 0/152 |
| Age, Continuous(years) | Active Group | Sham Group | Total |
|---|---|---|---|
| Mean | 62.27 ± 10.21 | 62.17 ± 9.33 | 62.22 ± 9.76 |
| Sex: Female, Male(Participants) | Active Group | Sham Group | Total |
|---|---|---|---|
| Female | 50 | 42 | 92 |
| Male | 42 | 48 | 90 |
| Ethnicity (NIH/OMB)(Participants) | Active Group | Sham Group | Total |
|---|---|---|---|
| Hispanic or Latino | 12 | 15 | 27 |
| Not Hispanic or Latino | 80 | 75 | 155 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Active Group | Sham Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 3 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 15 | 14 | 29 |
| White | 74 | 73 | 147 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Active Group | Sham Group | Total |
|---|---|---|---|
| United States | 92 | 90 | 182 |
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Peripheral Nervous System Diseases→
Regenesis Biomedical, Inc.