Diabetic Neuropathy, Painful Clinical Trial
Official title:
Long Term, Double Blind, Randomized, Placebo Controlled Multi-center Study of FRE.M.S.- Frequency Modulated Neural Stimulation Lorenz Therapy™ in Symptomatic Diabetic Neuropathy
Verified date | June 2012 |
Source | Lorenz Biotech S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
Aim of this study is to evaluate safety and efficacy of transcutaneous frequency modulated electromagnetic neural stimulation (FREMS) to treat symptomatic peripheral neuropathy in patients with diabetes mellitus.
Status | Completed |
Enrollment | 164 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Type 1 or Type 2 diabetes - Diabetes duration of > 1 year - Age: 18 to 75 years - Symptomatic neuropathy - Abnormal amplitude, latency or conduction velocity in at least one motor nerve (Tibial or Peroneal) or in the Sural Nerve - A measurable Sural Nerve conduction velocity - Stable glycemic control in the last 3 months, HbA1C < 11% - MDNS score > 7 - Stable dose of analgesic medications, if any, in the month prior enrollment Exclusion Criteria: - Previous treatment with TENS or other electrotherapy - Motor or Sensitive nerve conduction velocity < 30 non recordable/evocable - Unstable glycemic control during last 3 months - Pregnancy - Implanted pacemaker or defibrillator or neurostimulator - Cancer diagnosed in the last 5 years - Psychological or psychiatric disorders that in the Investigator's opinion may interfere with patient's compliance to study procedures - Active foot ulcer and/or major lower limb amputation - Diabetic mononeuropathy - Severe peripheral artery disease (Leriche Fontaine scale grade 3 and 4) - Ankle-brachial index (ABI) < 0.7 - Uremic neuropathy or end-stage renal disease - Toxic neuropathies - Severe hepatic disease - Alcohol consumption = 40 g/day or 30 units/week |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Paris-Nord University | Bondy | Ile del France |
Germany | Heinrich Heine University | Düsseldorf | |
Italy | San Raffaele Hospital & Scientific Institute | Milano | MI |
Italy | University of Padua | Padua | PD |
Italy | University of Perugia | Perugia | PG |
Italy | Tor Vergata University | Rome | RM |
Lead Sponsor | Collaborator |
---|---|
Lorenz Biotech S.p.A. |
France, Germany, Italy,
Bosi E, Conti M, Vermigli C, Cazzetta G, Peretti E, Cordoni MC, Galimberti G, Scionti L. Effectiveness of frequency-modulated electromagnetic neural stimulation in the treatment of painful diabetic neuropathy. Diabetologia. 2005 May;48(5):817-23. Epub 2005 Apr 15. — View Citation
Conti M, Peretti E, Cazzetta G, Galimberti G, Vermigli C, Pola R, Scionti L, Bosi E. Frequency-modulated electromagnetic neural stimulation enhances cutaneous microvascular flow in patients with diabetic neuropathy. J Diabetes Complications. 2009 Jan-Feb;23(1):46-8. doi: 10.1016/j.jdiacomp.2008.02.004. Epub 2008 Apr 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Nerve Conduction Velocity of the Deep Peroneal, Tibial, or Sural Nerve | Change in Nerve Conduction Velocity of the Deep Peroneal , Tibial, or Sural Nerve at 51 weeks (i.e., after three cycles of FREMS treatment) versus baseline | baseline and 51 weeks | No |
Secondary | Change in Vibration Perception Threshold | Change in Vibration Perception Threshold at 51 weeks (i.e., after three cycles of FREMS treatment) versus baseline | baseline and 51 weeks | No |
Secondary | Change in Cold Sensory Threshold | Change in Cold Sensory Threshold at 51 weeks (i.e., after three cycles of FREMS treatment) versus baseline | baseline and 51 weeks | No |
Secondary | Change in Warm Sensory Threshold | Change in Warm Sensory Threshold at 51 weeks (i.e., after three cycles of FREMS treatment) versus baseline | baseline and 51 weeks | No |
Secondary | Change in Day Pain Intensity (Visual Analogue Scale) | Change in Pain Intensity (assessed using Visual Analogue Scale) during day time with the first cycle of FREMS | baseline and week 3 | No |
Secondary | Change in Day Pain Intensity (Visual Analogue Scale) | Change in Pain Intensity (assessed using Visual Analogue Scale) during day time with the second cycle of FREMS | week 17 and week 20 | No |
Secondary | Change in Day Pain Intensity (Visual Analogue Scale) | Change in Pain Intensity (assessed using Visual Analogue Scale) during day time with the third cycle of FREMS | week 34 and week 37 | No |
Secondary | Change in Night Pain Intensity (Visual Analogue Scale) | Change in Pain Intensity (assessed using Visual Analogue Scale) during night time with the first cycle of FREMS | baseline and week 3 | No |
Secondary | Change in Night Pain Intensity (Visual Analogue Scale) | Change in Pain Intensity (assessed using Visual Analogue Scale) during night time with the second cycle of FREMS | week 17 and week 20 | No |
Secondary | Change in Night Pain Intensity (Visual Analogue Scale) | Change in Pain Intensity (assessed using Visual Analogue Scale) during night time with the third cycle of FREMS | week 34 and week 37 | No |
Secondary | Change in the Michigan Diabetic Neuropathy Score (MDNS) | Change in the Michigan Diabetic Neuropathy Score (MDNS) at 51 weeks (i.e. after three FREMS cycles) versus baseline | baseline and 51 weeks | No |
Secondary | Change in the dose and type of analgesic medications | Change in the dose and type of analgesic medications at week 51 (i.e. after three FREMS cycles) versus baseline | baseline and 51 weeks | No |
Secondary | Number of patients with treatment-related adverse events | Change in the dose and type of analgesic medications at week 51 (i.e. after three FREMS cycles) versus baseline | baseline and 51 weeks | No |
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