Status:
COMPLETED
Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy
Lead Sponsor:
IRCCS San Raffaele
Collaborating Sponsors:
Lorenz Biotech S.p.A.
University Of Perugia
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
We postulate that frequency-modulated electromagnetic stimulation (FREMS) may decrease pain in patients with painful diabetic neuropathy.
Detailed Description
The stuy was designed as a randomized, double-blind, placebo-controlled cross-over trial. Each patient received two series of ten treatments of either FREMS or placebo in random sequence, with each se...
Eligibility Criteria
Inclusion
- type 1 or type 2 diabetes (American Diabetes Association criteria)
- painful diabetic neuropathy with reduced sensory/motor nerve conduction velocity (i.e., \<40 m/sec in at least one nerve trunk of the lower limbs)
- vibration perception at the big toe \>25 V
Exclusion
- presence of any concomitant severe disease
- pregnancy
- renal disease (serum creatinine \>2.0 mg/dL)
- history or current foot ulcer
- lower limb arterial disease (ankle-brachial index \<0.9) or transcutaneous partial pressure of oxygen \<50 mmHg)
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00337324
Start Date
March 1 2002
End Date
May 1 2004
Last Update
June 15 2006
Active Locations (1)
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1
San Raffaele Hospital and Scientific Institute
Milan, (Mi), Italy, 20132