Trial Outcomes & Findings for Study of PEMF to Evaluate VPT and Thermal Sensory in Subjects With Diabetic Peripheral Neuropathy (NCT NCT03077893)

NCT ID: NCT03077893

Last Updated: 2019-07-30

Results Overview

A non-invasive test used in quantifying sensation/sensitivity to vibration in evaluating sensory dysfunction associated with diabetic neuropathy

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: Baseline to End of Treatment (Day 121)
• Results posted on: 2019-07-30

Participant Flow

A total of 44 subjects were enrolled into the trial and given active Provant Therapy. A total of 7 subjects dropped out of the study prior to being randomized 1:1 active to sham. Since these subjects withdrew from the study prior to assignment to an arm, they are not included in the randomized total of 37 (18 active and 19 sham).

Participant milestones

Measure	Active Group Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System	Sham Group Treatment with Inactive (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System
Overall Study STARTED	18	19
Overall Study COMPLETED	14	16
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of PEMF to Evaluate VPT and Thermal Sensory in Subjects With Diabetic Peripheral Neuropathy

Baseline characteristics by cohort

Measure	Active Group n=18 Participants Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System	Sham Group n=19 Participants Treatment with Inactive (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System	Total n=37 Participants Total of all reporting groups
Age, Continuous	62.5 years n=5 Participants	62.05 years n=7 Participants	62.27 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	19 participants n=7 Participants	37 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to End of Treatment (Day 121)

A non-invasive test used in quantifying sensation/sensitivity to vibration in evaluating sensory dysfunction associated with diabetic neuropathy

Outcome measures

Measure	Active Group n=17 Participants Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System	Sham Group n=18 Participants Treatment with Inactive (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System
Vibration Perception Threshold (VPT) Big Toe, change in VPT	9.26 amplitude in microns Standard Deviation 32.67	-3.59 amplitude in microns Standard Deviation 21.08
Vibration Perception Threshold (VPT) Plantar Aspect, change in VPT	9.18 amplitude in microns Standard Deviation 32.10	1.184 amplitude in microns Standard Deviation 19.66

PRIMARY outcome

Timeframe: Baseline to End of Treatment (Day 121)

Population: Number analyzed in outcome measure table is less than overall number analyzed due to drop-outs and technical issues with the QST machine.

QST is a noninvasive test used in peripheral nervous system disorders for thermal sensory testing.

Outcome measures

Measure	Active Group n=18 Participants Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System	Sham Group n=19 Participants Treatment with Inactive (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System
Quantitative Sensory Testing (QST) DAy 121 QST, Normal	7 Participants	8 Participants
Quantitative Sensory Testing (QST) Baseline QST, Abnormal Result	9 Participants	8 Participants
Quantitative Sensory Testing (QST) Baseline QST, Normal Result	6 Participants	6 Participants
Quantitative Sensory Testing (QST) Day 121 QST, Abnormal Result	4 Participants	4 Participants

SECONDARY outcome

Timeframe: The sural nerve conduction velocity will be recorded at the Enrollment Visit and end of study visit (Day 121).

NC-stat® DPNCheck® will be used to record NCV at Baseline and Day 121. Outcome Measure Data table displays change in NCV from Baseline to Day 121.

Outcome measures

Measure	Active Group n=16 Participants Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System	Sham Group n=13 Participants Treatment with Inactive (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System
Nerve Conduction Velocity (NCV) - Velocity	1.69 micro volts Standard Deviation 15.15	-4.23 micro volts Standard Deviation 13.49

SECONDARY outcome

Timeframe: SPP will be conducted at the Enrollment Visit, Day 61, and end of study visit (Day 121).

The Vasamed Sensilase PAD-IQ will be used to record SPP. This machine measures pressure (in mm Hg) of microcirculation using a laser Doppler sensor. Outcome Measure Data Table below displays change from Baseline to Day 121.

Outcome measures

Measure	Active Group n=17 Participants Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System	Sham Group n=15 Participants Treatment with Inactive (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System
Skin Perfusion Pressures (SPP) Change in Dorsal SPP	.35 mmHg Standard Deviation 34.54	3.07 mmHg Standard Deviation 40.16
Skin Perfusion Pressures (SPP) Change in Medial Plantar SPP	-12.11 mmHg Standard Deviation 32.98	-2.06 mmHg Standard Deviation 32.38

SECONDARY outcome

Timeframe: Collected as patient-reported outcomes on a paper diary and at the Enrollment visit to obtain a baseline value and on Days 61, 75, and 91

Mean change from Baseline to Day 121, using a validated 11-point Numeric Pain Rating Scale (NPRS) with scores 0-10, where 0 = no pain and 10 = worst possible pain.

Outcome measures

Measure	Active Group n=13 Participants Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System	Sham Group n=15 Participants Treatment with Inactive (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System
Pain Intensity (PI)	-2.69 units on a scale Standard Deviation 2.47	-2.04 units on a scale Standard Deviation 2.67

SECONDARY outcome

Timeframe: Change in BPI, pain right now question, from Baseline to Day 121.

The BPI long form will be administered at the Enrollment Visit, Day 30, 61, 91, and end of study visit (Day 121). Results for question #15 on Pain Right Now displayed below. Subject were asked to rate pain right now on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).

Outcome measures

Measure	Active Group n=17 Participants Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System	Sham Group n=17 Participants Treatment with Inactive (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System
Brief Pain Inventory (BPI); Question on Pain Right Now.	-1.65 units on a scale Standard Deviation 3.02	-1.71 units on a scale Standard Deviation 2.78

SECONDARY outcome

Timeframe: Change from Baseline to Day 121 in BFI.

A 4-question assessment that assesses the level of fatigue and the impact of the fatigue on daily function over the last 24 hours. BFI is patient reported and collected at the Enrollment Visit, Days 30, 61, 91, and end of study visit (Day 121). A global fatigue score was calculated by averaging all of the values on the questionnaire and results for the change from Baseline to Day 121 are displayed below. The scale ranged from 0 (no fatigue/does not interfere) to 10 (as bad as you can imagine/completely interferes).

Outcome measures

Measure	Active Group n=17 Participants Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System	Sham Group n=18 Participants Treatment with Inactive (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System
Brief Fatigue Inventory (BFI)	-1.65 units on a scale Standard Deviation 3.13	-2.3 units on a scale Standard Deviation 1.98

SECONDARY outcome

Timeframe: PGIC results at Day 121 displayed below.

A 7-choice validated categorical scale of overall change in status since initiation of treatment with the study device.PGIC was collected every 7 days in the paper diary, immediately following the morning treatment. Subjects were asked: Since the start of the study, my overall status is? Choices on the scale included: Very much worse, much worse, minimally worse, no change, minimally improved, much improved and very much improved.

Outcome measures

Measure	Active Group n=18 Participants Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System	Sham Group n=19 Participants Treatment with Inactive (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System
Patient Global Impression of Change (PGIC) Not Reported	8 Participants	5 Participants
Patient Global Impression of Change (PGIC) Very Much Worse	1 Participants	1 Participants
Patient Global Impression of Change (PGIC) Much Worse	1 Participants	2 Participants
Patient Global Impression of Change (PGIC) Worse	5 Participants	1 Participants
Patient Global Impression of Change (PGIC) Improved	1 Participants	2 Participants
Patient Global Impression of Change (PGIC) Very Improved	0 Participants	1 Participants
Patient Global Impression of Change (PGIC) Very Much Improved	0 Participants	3 Participants
Patient Global Impression of Change (PGIC) No Change	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Change in Depression and Anxiety from Baseline to Day 121.

A patient reported 14 question assessment that detects the status of depression and anxiety. Subjects completed the assessment at the Enrollment Visit, Days 30, 61, 91, and end of study visit (Day 121). The total score for anxiety and the total score for depression was calculated at Day 121. Low scores represent normal (0-7) while high scores represent abnormal (11-21).

Outcome measures

Measure	Active Group n=17 Participants Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System	Sham Group n=18 Participants Treatment with Inactive (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System
Hospital Anxiety and Depression Scale (HADS) Mean change in depression	-.08 units on a scale Standard Deviation 2.23	-.50 units on a scale Standard Deviation 2.81
Hospital Anxiety and Depression Scale (HADS) Mean change in anxiety	-.12 units on a scale Standard Deviation 2.55	-.94 units on a scale Standard Deviation 4.53

SECONDARY outcome

Timeframe: Change in each domain from Baseline to Day 121 is displayed below.

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.

Outcome measures

Measure	Active Group n=16 Participants Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System	Sham Group n=17 Participants Treatment with Inactive (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System
Neuro-QoL Change in Domain 1: Pain	-.22 units on a scale Standard Deviation .84	-.54 units on a scale Standard Deviation .90
Neuro-QoL Change in Domain 2: Lost/Reducsed Feeling	-.02 units on a scale Standard Deviation 1.13	-.37 units on a scale Standard Deviation .97
Neuro-QoL Change in Domain 3: Diffuse Sensory Motor Symptoms	.06 units on a scale Standard Deviation .52	-.35 units on a scale Standard Deviation .80
Neuro-QoL Change in Domain 4: Restrictions in Activities	-.12 units on a scale Standard Deviation 1.41	-.5 units on a scale Standard Deviation 1.16
Neuro-QoL Change in Domain 5: Disruptions	-.13 units on a scale Standard Deviation .45	-.15 units on a scale Standard Deviation .84
Neuro-QoL Change in Domain 6: Emotional Distress	-.25 units on a scale Standard Deviation .52	-.29 units on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: The sural nerve conduction amplitude will be recorded at the Enrollment Visit and end of study visit (Day 121).

NC-stat® DPNCheck® will be used to record NCV at Baseline and Day 121. Outcome Measure Data table displays change in NCV from Baseline to Day 121.

Outcome measures

Measure	Active Group n=16 Participants Treatment with active Provant Therapy System Active Provant Therapy System: Treatment with active Provant Therapy System	Sham Group n=13 Participants Treatment with Inactive (sham) Provant Therapy System Inactive (sham) Provant Therapy System: Treatment with Inactive (sham) Provant Therapy System
Nerve Conduction Velocity (NCV) - Amplitude	1.56 meters/second Standard Deviation 7.68	4.38 meters/second Standard Deviation 13.21

Adverse Events

2 Month Lead-in Active Group

Serious events: 2 serious events

Other events: 2 other events

Deaths: 8 deaths

Active Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Sham Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	2 Month Lead-in Active Group n=44 participants at risk Treatment with active Provant Therapy System. Subjects treated with active device during the lead-in part of the study (prior to randomization).	Active Group n=44 participants at risk Subjects randomized to treat with active Provant Therapy System.	Sham Group n=44 participants at risk Subjects randomized to treat with sham device.
Cardiac disorders Elevated troponins and shortness of breath	2.3% 1/44 • Number of events 1 • Adverse events were collected and recorded for approximately 9 months, from 16 March 2017 to 21 December 2017. Adverse Events are separated out between the "2 month lead-in active", "sham group" and "active group". Definition does not differ.	0.00% 0/44 • Adverse events were collected and recorded for approximately 9 months, from 16 March 2017 to 21 December 2017. Adverse Events are separated out between the "2 month lead-in active", "sham group" and "active group". Definition does not differ.	0.00% 0/44 • Adverse events were collected and recorded for approximately 9 months, from 16 March 2017 to 21 December 2017. Adverse Events are separated out between the "2 month lead-in active", "sham group" and "active group". Definition does not differ.
Nervous system disorders Concussion / Cerebrovascular Accident	2.3% 1/44 • Number of events 2 • Adverse events were collected and recorded for approximately 9 months, from 16 March 2017 to 21 December 2017. Adverse Events are separated out between the "2 month lead-in active", "sham group" and "active group". Definition does not differ.	0.00% 0/44 • Adverse events were collected and recorded for approximately 9 months, from 16 March 2017 to 21 December 2017. Adverse Events are separated out between the "2 month lead-in active", "sham group" and "active group". Definition does not differ.	0.00% 0/44 • Adverse events were collected and recorded for approximately 9 months, from 16 March 2017 to 21 December 2017. Adverse Events are separated out between the "2 month lead-in active", "sham group" and "active group". Definition does not differ.

Other adverse events

Measure	2 Month Lead-in Active Group n=44 participants at risk Treatment with active Provant Therapy System. Subjects treated with active device during the lead-in part of the study (prior to randomization).	Active Group n=44 participants at risk Subjects randomized to treat with active Provant Therapy System.	Sham Group n=44 participants at risk Subjects randomized to treat with sham device.
Nervous system disorders Pain in feet/foot	4.5% 2/44 • Number of events 2 • Adverse events were collected and recorded for approximately 9 months, from 16 March 2017 to 21 December 2017. Adverse Events are separated out between the "2 month lead-in active", "sham group" and "active group". Definition does not differ.	0.00% 0/44 • Adverse events were collected and recorded for approximately 9 months, from 16 March 2017 to 21 December 2017. Adverse Events are separated out between the "2 month lead-in active", "sham group" and "active group". Definition does not differ.	0.00% 0/44 • Adverse events were collected and recorded for approximately 9 months, from 16 March 2017 to 21 December 2017. Adverse Events are separated out between the "2 month lead-in active", "sham group" and "active group". Definition does not differ.

Additional Information

Heather M Vander Ploeg

Regenesis Biomedical

Phone: 602-428-7041

Email: heather.vanderploeg@regenesisbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER