Who is sponsoring NCT03077893?

NCT03077893 is sponsored by Regenesis Biomedical, Inc..

What drugs are being tested in NCT03077893?

Interventions in NCT03077893: Active Provant Therapy System, Inactive (sham) Provant Therapy System.

What condition does NCT03077893 study?

NCT03077893 studies Diabetic Peripheral Neuropathy.

Is NCT03077893 still recruiting?

NCT03077893 is currently completed. Last updated 30 July 2019.

Are results published for NCT03077893?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-07-30 · How we verify

NCT03077893

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 30 July 2019

What this trial tests

NA trial testing Active Provant Therapy System in Diabetic Peripheral Neuropathy in 44 participants. Completed in 26 December 2017.

Timeline

9 March 2017

Primary endpoint
26 December 2017

26 December 2017

Quick facts

Lead sponsor	Regenesis Biomedical, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	44
Start date	9 March 2017
Primary completion	26 December 2017
Estimated completion	26 December 2017
Sites	1 location across United States

Drugs / interventions tested

Active Provant Therapy System
Inactive (sham) Provant Therapy System

Conditions studied

Diabetic Peripheral Neuropathy — all drugs for Diabetic Peripheral Neuropathy →

Sponsor

Regenesis Biomedical, Inc.

Who can join

Adults 22 to 80, any sex, with Diabetic Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Vibration Perception Threshold (VPT) Primary · 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

Big Toe, change in VPT

Group	Value	95% CI
Active Group	9.26	± 32.67
Sham Group	-3.59	± 21.08

Plantar Aspect, change in VPT

Group	Value	95% CI
Active Group	9.18	± 32.10
Sham Group	1.184	± 19.66

Quantitative Sensory Testing (QST) Primary · Baseline to End of Treatment (Day 121)

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

Baseline QST, Abnormal Result

Group	Value	95% CI
Active Group	9
Sham Group	8

Baseline QST, Normal Result

Group	Value	95% CI
Active Group	6
Sham Group	6

Day 121 QST, Abnormal Result

Group	Value	95% CI
Active Group	4
Sham Group	4

DAy 121 QST, Normal

Group	Value	95% CI
Active Group	7
Sham Group	8

Nerve Conduction Velocity (NCV) - Velocity Secondary · 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.

Group	Value	95% CI
Active Group	1.69	± 15.15
Sham Group	-4.23	± 13.49

Skin Perfusion Pressures (SPP) Secondary · 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.

Change in Dorsal SPP

Group	Value	95% CI
Active Group	.35	± 34.54
Sham Group	3.07	± 40.16

Change in Medial Plantar SPP

Group	Value	95% CI
Active Group	-12.11	± 32.98
Sham Group	-2.06	± 32.38

Pain Intensity (PI) Secondary · 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.

Group	Value	95% CI
Active Group	-2.69	± 2.47
Sham Group	-2.04	± 2.67

Brief Pain Inventory (BPI); Question on Pain Right Now. Secondary · 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).

Group	Value	95% CI
Active Group	-1.65	± 3.02
Sham Group	-1.71	± 2.78

Brief Fatigue Inventory (BFI) Secondary · 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).

Group	Value	95% CI
Active Group	-1.65	± 3.13
Sham Group	-2.3	± 1.98

Patient Global Impression of Change (PGIC) Secondary · 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.

Group	Value	95% CI
Active Group	8
Sham Group	5
Active Group	1
Sham Group	1
Active Group	1
Sham Group	2
Active Group	5
Sham Group	1

Hospital Anxiety and Depression Scale (HADS) Secondary · 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).

Mean change in depression

Group	Value	95% CI
Active Group	-.08	± 2.23
Sham Group	-.50	± 2.81

Mean change in anxiety

Group	Value	95% CI
Active Group	-.12	± 2.55
Sham Group	-.94	± 4.53

Neuro-QoL Secondary · 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 calcul

Change in Domain 1: Pain

Group	Value	95% CI
Active Group	-.22	± .84
Sham Group	-.54	± .90

Change in Domain 2: Lost/Reducsed Feeling

Group	Value	95% CI
Active Group	-.02	± 1.13
Sham Group	-.37	± .97

Change in Domain 3: Diffuse Sensory Motor Symptoms

Group	Value	95% CI
Active Group	.06	± .52
Sham Group	-.35	± .80

Change in Domain 4: Restrictions in Activities

Group	Value	95% CI
Active Group	-.12	± 1.41
Sham Group	-.5	± 1.16

Change in Domain 5: Disruptions

Group	Value	95% CI
Active Group	-.13	± .45
Sham Group	-.15	± .84

Change in Domain 6: Emotional Distress

Group	Value	95% CI
Active Group	-.25	± .52
Sham Group	-.29	± 1.07

Nerve Conduction Velocity (NCV) - Amplitude Secondary · 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.

Group	Value	95% CI
Active Group	1.56	± 7.68
Sham Group	4.38	± 13.21

Adverse events — posted to ClinicalTrials.gov

Time frame: 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".. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

2 Month Lead-in Active Group

Serious: 2/44 (5%)

Deaths: 8/44

Active Group

Serious: 0/44 (0%)

Deaths: 3/44

Sham Group

Serious: 0/44 (0%)

Deaths: 2/44

Serious adverse events (2 terms)

Reaction	System	2 Month Lead-in Active Group	Active Group	Sham Group
Elevated troponins and shortness of breath	Cardiac disorders	—	—	—
Concussion / Cerebrovascular Accident	Nervous system disorders	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	2 Month Lead-in Active Group	Active Group	Sham Group
Pain in feet/foot	Nervous system disorders	—	—	—

Most-reported serious reactions: Elevated troponins and shortness of breath, Concussion / Cerebrovascular Accident.

Data from ClinicalTrials.gov NCT03077893 adverse events section.

Sponsor's own description

A study to demonstrate the effectiveness of PEMF treatment compared to sham treatment in changing Vibration Perception Threshold (VPT) and Thermal Sensory (QST) in patients with diabetic peripheral neuropathy (DPN) when treatment is administered twice daily through 120-day period.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Active Provant Therapy System

Trials testing the same drug.

NCT03455543 — Dual Field PEMF Therapy in Lower Extremity Painful Diabetic Distal Symmetric Peripheral Neuropathy · NA · completed

Other recruiting trials for Diabetic Peripheral Neuropathy

Currently open trials in the same condition.

NCT07380880 — Comparison of Proprioceptive Neuromuscular Training and Sensory Re-education in Patients With Diabetic Peripheral Neurop · NA · recruiting
NCT06591780 — Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy · NA · recruiting
NCT07036796 — Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy · Phase 2 · recruiting
NCT07085130 — The Effect of Hand and Foot Exercises Combined With Cold Application or Virtual Reality on Diabetic Neuropathy · NA · active not recruiting
NCT06483620 — Cross-cultural Adaptation and Validity of the Arabic-translated NEUROPATHY-SPECIFIC QUALITY OF LIFE Questionnaire · recruiting

Other Regenesis Biomedical, Inc. trials

Trials by the same sponsor.

NCT04300907 — An Open-Label Trial of PEMF Therapy [Provant Infinity Therapy System] for Home Use in Postoperative Pain · NA · withdrawn
NCT03455543 — Dual Field PEMF Therapy in Lower Extremity Painful Diabetic Distal Symmetric Peripheral Neuropathy · NA · completed
NCT02696083 — Proof of Concept Study of PEMF (Pulsed Electromagnetic Field) Therapy in Subjects With Osteoarthritis of the Knee · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03077893 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Regenesis Biomedical, Inc.
Last refreshed: 30 July 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03077893.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing