N/A
N=182
Dual Field PEMF Therapy in Lower Extremity Painful Diabetic Distal Symmetric Peripheral Neuropathy
Diabetic Neuropathy Peripheral
Bottom Line
View on ClinicalTrials.gov: NCT03455543 ↗Enrolled (actual)
182
Serious AEs
4.8%
Results posted
Mar 2020
Primary outcome: Primary: Change in Pain Intensity — -1.47; -1.25 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Provant Therapy System (Device); Inactive (sham) Provant Therapy System (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Regenesis Biomedical, Inc.
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Intensity |
-1.47; -1.25 | — |
| SECONDARY Patients With 2 Point or 30% Reduction in Pain at 4 Months |
28; 26 | — |
| SECONDARY Patient Global Impression at 4 Months |
1; 2; 3; 11; 24; 28 | — |
| SECONDARY Time to 30% or 2-point Reduction in NPRS, Whichever Comes First, Through 4 Months |
4; 3; 18; 18; 32; 27 | — |
| SECONDARY Change in Neuropathy Related Quality of Life (NeuroQoL) Between Baseline and End of Treatment at 4 Months. |
-1.66; -1.52; -1.03; -1.42; -0.92; -0.79 | — |
| SECONDARY Change is Skin Perfusion Pressure (SPP) for Baseline to End of Treatment at 4 Months |
-0.25; 3.27; -0.74; 2.93; 6.37; -1.84 | — |
| SECONDARY Changes in Nerve Conduction Studies of Velocity Between Baseline and End of Treatment at 4 Months. |
-4.15; -5.12; -1.11; -5.06 | — |
| SECONDARY Changes in Quantitative Sensory Testing (QST) Between Baseline and End of Treatment at 4 Months. |
0.57; -0.21; 0.08; 0.02; -0.58; -0.54 | — |
| SECONDARY Changes in Nerve Conduction Studies of Amplitude Between Baseline and End of Treatment at 4 Months. |
1.27; 1.36; 1.95; 1.03 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03455543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.