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

Completed · Not applicable · Has a placebo group

Conditions studied: Diabetic Neuropathy Peripheral

In brief

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.

Key facts

Study ID

NCT03455543

Run by

Regenesis Biomedical, Inc.

People needed

182

Starts

2018-03-26

Expected to finish

2019-07-18

Last updated by the study team

2020-07-15

Who can join

Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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)
• 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)

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
• 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

Where it is running

• Physician's Research Group — Mesa, Arizona, United States
• Valley Clinical Research — Northridge, California, United States
• Northern California Research — Sacramento, California, United States
• Diabetes Research Center — Tustin, California, United States
• Mountain View Clinical Research — Denver, Colorado, United States
• Lake Internal Medicine Associates — Eustis, Florida, United States
• Clinical Physiology Associates — Fort Myers, Florida, United States
• Spotlight Research Center — Miami, Florida, United States
• Clinical Research of Central Florida — Winter Haven, Florida, United States
• River Birch Research Alliance, LLC — Blue Ridge, Georgia, United States
• MediSphere Medical Research Center, LLC — Evansville, Indiana, United States
• Heartland Research Associate, LLC — Wichita, Kansas, United States
• Healthcare Research Network — Hazelwood, Missouri, United States
• The Center for Pharmaceutical Research, LLC — Kansas City, Missouri, United States
• Palm Research Center — Las Vegas, Nevada, United States
• Great Lakes Medical Resarch — Westfield, New York, United States
• Wake Family Medicine, PC — Cary, North Carolina, United States
• Rainier Clinical Research — Renton, Washington, United States

Full record on ClinicalTrials.gov

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