Status:
COMPLETED
Dual Field PEMF Therapy in Lower Extremity Painful Diabetic Distal Symmetric Peripheral Neuropathy
Lead Sponsor:
Regenesis Biomedical, Inc.
Conditions:
Diabetic Neuropathy Peripheral
Eligibility:
All Genders
22-80 years
Phase:
NA
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...
Detailed Description
Eligible subjects will be entered into a 14-day ePRO diary run-in period to collect average baseline pain scores related to their diabetic neuropathy in the lower extremities, diary compliance, and an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2019
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT03455543
Start Date
March 26 2018
End Date
July 18 2019
Last Update
July 15 2020
Active Locations (18)
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1
Physician's Research Group
Mesa, Arizona, United States, 85206
2
Valley Clinical Research
Northridge, California, United States, 91325
3
Northern California Research
Sacramento, California, United States, 95821
4
Diabetes Research Center
Tustin, California, United States, 92780