Dual Field PEMF Therapy in Lower Extremity Painful Diabetic Distal Symmetric Peripheral Neuropathy

NCT03455543 | Completed Results FDA Device

• 1 other identifier: RBI.2017.002
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Diabetic Neuropathy Peripheral

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Patients With 2 Point or 30% Reduction in Pain at 4 Months

  Baseline to 4 months

• Patient Global Impression at 4 Months

  Baseline through 4 months.

• Time to 30% or 2-point Reduction in NPRS, Whichever Comes First, Through 4 Months

  Through 4 months

• Change in Neuropathy Related Quality of Life (NeuroQoL) Between Baseline and End of Treatment at 4 Months.

  Baseline to 4 months

• Change is Skin Perfusion Pressure (SPP) for Baseline to End of Treatment at 4 Months

  Baseline to 4 months

Other Outcomes (8)

• Exploratory Endpoint: Changes in the Work Productivity and Activity Impairment Questionnaire (WPAIQ) (Questions 2-4)

  Baseline to 4 Months

• Exploratory Endpoint: Changes in Intraepidermal Nerve Fiber Density (IENFD) at the Distal Thigh and Distal Leg - Part A

  Baseline to Month 4

• Exploratory Endpoint: Change in Pain Intensity During Part B

  Baseline through 12 months

Study Arms (2)

Active Group

EXPERIMENTAL

Treatment with active Provant Therapy System

Device: Active Provant Therapy System

Sham Group

SHAM COMPARATOR

Treatment with in-active (sham) Provant Therapy System

Device: Inactive (sham) Provant Therapy System

Interventions

Active Provant Therapy System DEVICE

Treatment with active Provant Therapy System

Active Group

Inactive (sham) Provant Therapy System DEVICE

Treatment with inactive Provant Therapy System

Sham Group

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or Type 2 diabetes
• Pain attributed to symmetrical lower extremity diabetic peripheral neuropathy for at least 6 months
• DPN pain over the preceding 24 hours is ≥4 and \<9 based on the 11-point NPRS (0-10)
• to 80 years of age
• On stable diabetes treatment
• HbA1c less than or equal to 10%
• No recent changes to analgesic prescriptions
• ABI of ≥0.8 to ≤1.3
• Walks independently
• Willing and able to give consent
• If female, must be post-menopausal, surgically sterile, abstinent or practicing an effective method of birth control
• Can access an internet browser or smart phone
• 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)

You may not qualify if:

• Active, open ulcer on either extremity
• Significant peripheral vascular disease
• Venous insufficiency
• History of solid organ transplant or severe renal disease
• Diagnosed with a non-diabetic cause of chronic neuropathy
• Previous or current history of primary or tertiary hyperparathyroidism, hypercalcemia, psychiatric disorder, alcohol dependency, Hepatitis B or C, or HIV infection
• Significant cardiovascular disease
• Uncontrolled medical illness
• Requires or anticipates the need for surgery during the study
• Total foot depth of \>8 cm
• Has received any investigational drug or device within 30 days
• Has used systemic corticosteroids within 3 months
• History of malignancy within 5 years in treatment area
• A psychiatric disorder of sufficient severity
• Receiving prn narcotic medications

Sponsors & Collaborators

• Regenesis Biomedical, Inc.: lead

Study Sites (18)

Physician's Research Group

Mesa, Arizona, 85206, United States

Location

Valley Clinical Research

Northridge, California, 91325, United States

Location

Northern California Research

Sacramento, California, 95821, United States

Location

Diabetes Research Center

Tustin, California, 92780, United States

Location

Mountain View Clinical Research

Denver, Colorado, 80209, United States

Location

Lake Internal Medicine Associates

Eustis, Florida, 32726, United States

Location

Clinical Physiology Associates

Fort Myers, Florida, 33912, United States

Location

Spotlight Research Center

Miami, Florida, 33176, United States

Location

Clinical Research of Central Florida

Winter Haven, Florida, 33880, United States

Location

River Birch Research Alliance, LLC

Blue Ridge, Georgia, 30514, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Heartland Research Associate, LLC

Wichita, Kansas, 67207, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

The Center for Pharmaceutical Research, LLC

Kansas City, Missouri, 64114, United States

Location

Palm Research Center

Las Vegas, Nevada, 89128, United States

Location

Great Lakes Medical Resarch

Westfield, New York, 14787, United States

Location

Wake Family Medicine, PC

Cary, North Carolina, 27513, United States

Location

Rainier Clinical Research

Renton, Washington, 98057, United States

Location

Results Point of Contact

• Title: Heather Vander Ploeg
• Organization: Regenesis Biomedical

heather.vanderploeg@regenesisbio.com

602-428-7041

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Active and sham devices will look identical. Participants and site staff will be blind to the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 6, 2018
• Study Start: March 26, 2018
• Primary Completion: November 14, 2018
• Study Completion: July 18, 2019
• Last Updated: July 15, 2020
• Results First Posted: March 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)