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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03455543
Recruitment Status : Completed
First Posted : March 6, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Regenesis Biomedical, Inc.

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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Peripheral Device: Active Provant Therapy System Device: Inactive (sham) Provant Therapy System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Active and sham devices will look identical. Participants and site staff will be blind to the randomization.
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind, Sham-Controlled, Randomized Trial of Dual Field PEMF Therapy [Provant® Therapy System] in Lower Extremity Painful Diabetic Distal Symmetric Peripheral Neuropathy (DSPN) (The RELIEF Trial)
Actual Study Start Date : March 26, 2018
Actual Primary Completion Date : November 14, 2018
Actual Study Completion Date : July 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Group
Treatment with active Provant Therapy System
Device: Active Provant Therapy System
Treatment with active Provant Therapy System

Sham Comparator: Sham Group
Treatment with in-active (sham) Provant Therapy System
Device: Inactive (sham) Provant Therapy System
Treatment with inactive Provant Therapy System




Primary Outcome Measures :
  1. Change in pain intensity [ Time Frame: Baseline 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).


Secondary Outcome Measures :
  1. Patients with 2 point or 30% reduction in pain [ Time Frame: Baseline to 4 months ]
    Percentage of patients who have either a 2 point or 30% reduction in (pain) NPRS at 4 Months.

  2. Patient Global Impression [ Time Frame: Baseline through 4 months. ]
    Change in Patient Global Impression at 4 Months.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • 22 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)

Exclusion Criteria:

  • 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
  • History of drug or alcohol abuse within 1 year
  • Implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s0
  • Pregnant or planning to become pregnant
  • Previous treatment with Provant Therapy
  • Unwilling to follow instructions or comply with study instructions
  • Pain from any other source that could confuse DPN pain assessment
  • Clinically significant foot deformity
  • Skin condition that could alter peripheral sensations
  • Previous surgery to the spine or lower extremity with residual symptoms of pain or difficulty with movement.
  • Clinically significant arthropathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455543


Locations
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Sponsors and Collaborators
Regenesis Biomedical, Inc.

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Responsible Party: Regenesis Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT03455543    
Other Study ID Numbers: RBI.2017.002
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases