A study to demonstrate the effectiveness of PEMF treatment compared to sham treatment in changing Vibration Perception Threshold (VPT) and Thermal Sensory (QST) in patients with diabetic peripheral neuropathy (DPN) when treatment is administered twice daily through 120-day period.
Multi-center, sham-controlled, double-blind, enriched enrollment, randomized withdrawal clinical trial conducted on subjects with bilateral symmetrical diabetic peripheral neuropathy. Eligible subjects will include those between 22 and 80 years of age with Type 1 or Type 2 diabetes having persistent pain, numbness, tingling, or burning in both feet despite treatment. Eligible subjects will receive two active treatment devices (one for each foot, to allow simultaneous treatment) and treat at home, twice daily for 60 days after which they will return to the clinic at Day 61 for a response assessment. Subjects that are determined to be responders at Day 61 (subjects that achieve a 1-point decrease in the average pain score over the last 24 hours using the Numeric Pain Rating Scale (NPRS)) will be randomized 1:1 to either active treatment or inactive sham devices and will continue treating through Day 120. Subjects that are determined to be non-responders at Day 61 will continue treating with the active devices given at enrollment and will return to the clinic at Day 75 and Day 91 for a response assessment. If a subject is determined to be a responder at Day 75, they will be randomized 1:1 to receive either active treatment or inactive sham and will continue treating through Day 120. If a subject is determined to be a responder at Day 91, they will be randomized 1:1 to receive either active treatment or sham and will continue to treat through Day 120. If a subject continues to be a non-responder at Day 91 they will be terminated from the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Treatment with active Provant Therapy System
Treatment with Inactive (sham) Provant Therapy System
Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, United States
Vibration Perception Threshold (VPT)
A non-invasive test used in quantifying sensation/sensitivity to vibration in evaluating sensory dysfunction associated with diabetic neuropathy
Time frame: Baseline to End of Treatment (Day 121)
Quantitative Sensory Testing (QST)
QST is a noninvasive test used in peripheral nervous system disorders for thermal sensory testing.
Time frame: Baseline to End of Treatment (Day 121)
Nerve Conduction Velocity (NCV) - Velocity
NC-stat® DPNCheck® will be used to record NCV at Baseline and Day 121. Outcome Measure Data table displays change in NCV from Baseline to Day 121.
Time frame: The sural nerve conduction velocity will be recorded at the Enrollment Visit and end of study visit (Day 121).
Skin Perfusion Pressures (SPP)
The Vasamed Sensilase PAD-IQ will be used to record SPP. This machine measures pressure (in mm Hg) of microcirculation using a laser Doppler sensor. Outcome Measure Data Table below displays change from Baseline to Day 121.
Time frame: SPP will be conducted at the Enrollment Visit, Day 61, and end of study visit (Day 121).
Pain Intensity (PI)
Mean change from Baseline to Day 121, using a validated 11-point Numeric Pain Rating Scale (NPRS) with scores 0-10, where 0 = no pain and 10 = worst possible pain.
Time frame: Collected as patient-reported outcomes on a paper diary and at the Enrollment visit to obtain a baseline value and on Days 61, 75, and 91
Brief Pain Inventory (BPI); Question on Pain Right Now.
The BPI long form will be administered at the Enrollment Visit, Day 30, 61, 91, and end of study visit (Day 121). Results for question #15 on Pain Right Now displayed below. Subject were asked to rate pain right now on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
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Time frame: Change in BPI, pain right now question, from Baseline to Day 121.
Brief Fatigue Inventory (BFI)
A 4-question assessment that assesses the level of fatigue and the impact of the fatigue on daily function over the last 24 hours. BFI is patient reported and collected at the Enrollment Visit, Days 30, 61, 91, and end of study visit (Day 121). A global fatigue score was calculated by averaging all of the values on the questionnaire and results for the change from Baseline to Day 121 are displayed below. The scale ranged from 0 (no fatigue/does not interfere) to 10 (as bad as you can imagine/completely interferes).
Time frame: Change from Baseline to Day 121 in BFI.
Patient Global Impression of Change (PGIC)
A 7-choice validated categorical scale of overall change in status since initiation of treatment with the study device.PGIC was collected every 7 days in the paper diary, immediately following the morning treatment. Subjects were asked: Since the start of the study, my overall status is? Choices on the scale included: Very much worse, much worse, minimally worse, no change, minimally improved, much improved and very much improved.
Time frame: PGIC results at Day 121 displayed below.
Hospital Anxiety and Depression Scale (HADS)
A patient reported 14 question assessment that detects the status of depression and anxiety. Subjects completed the assessment at the Enrollment Visit, Days 30, 61, 91, and end of study visit (Day 121). The total score for anxiety and the total score for depression was calculated at Day 121. Low scores represent normal (0-7) while high scores represent abnormal (11-21).
Time frame: Change in Depression and Anxiety from Baseline to Day 121.
Neuro-QoL
A validated set of health-related quality of life measures that are domain specific.Subjects will completed 6 domains: (1) Pain, (2) Lost/Reduced Feeling, (3) Diffuse Sensory Motor Symptoms, (4) Restrictions in Activities of Daily Living, (5) Disruptions in Social Relationships, and (6) Emotional Distress.The short forms were completed by the subject at the Enrollment Visit and end of study visit (Day 121). Each question in the domain was rated on a symptom scale from 1 (never) to 5 (all the time) and a bothersome scale from 1 (none) to 3 (very much). The total score for the domain was calculated by multiplying the symptom score by the bothersome score. The scale range is from 1 to 15 where the minimum (best/least symptomatic) score is 1 and the maximum (worst/most symptomatic) score is 15.
Time frame: Change in each domain from Baseline to Day 121 is displayed below.
Nerve Conduction Velocity (NCV) - Amplitude
NC-stat® DPNCheck® will be used to record NCV at Baseline and Day 121. Outcome Measure Data table displays change in NCV from Baseline to Day 121.
Time frame: The sural nerve conduction amplitude will be recorded at the Enrollment Visit and end of study visit (Day 121).