Status:
COMPLETED
Effect of Pulsing Electrical Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study
Lead Sponsor:
MedRelief
Conditions:
Diabetic Peripheral Neuropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
To determine if pulsed electric field therapy reduces lower leg and foot pain associated with diabetic neuropathy and lessens the need for medication. The MedRelief device sends a sub-threshold elect...
Detailed Description
A multi-center, randomized, open-label study involving 23 patients with chronic diabetic peripheral neuropathy meeting study entry criteria. Subjects will be randomly assigned to receive one of two tr...
Eligibility Criteria
Inclusion
- currently diagnosed with diabetes mellitus
- confirmed diagnosis of diabetic peripheral neuropathy
- age 18 years to 75 years
- both males and females are eligible for study participation
- HgA1c level under 9
- Physician confirmed stable glycemic control for 3 months prior to enrollment
- baseline pain level over previous month of 5
- willing to sign IRB approved consent and follow study visit requirements
- if female of childbearing age willing to undergo urine pregnancy test
Exclusion
- \-
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00614341
Start Date
May 1 2006
End Date
January 1 2008
Last Update
February 13 2008
Active Locations (1)
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1
Nephrology and Rheumatology Associates
Augusta, Georgia, United States, 30909