Back to resultsEffect of Pulsing Electrical Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study (DPN)
Primary Purpose
Diabetic Peripheral Neuropathy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
MedRelief SE 55
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathy focused on measuring diabetes mellitus, neuropathy, distal symmetric polyneuropathy, pulsed electric fild
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
-
Sites / Locations
- Nephrology and Rheumatology Associates
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
1, 2
Arm Description
Pulse MedRelief SE 55 Continuous MedRelief SE 55
Outcomes
Primary Outcome Measures
Pain reduction in diabetic patients with chronic diabetic neuropathy
Secondary Outcome Measures
Improvement in sensation and overall foot condition
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00614341
Brief Title
Effect of Pulsing Electrical Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study
Acronym
DPN
Official Title
A Phase IV Clinical Trial. Effect of Pulsing Electromagnetic Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MedRelief
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 electric signal through the skin using electrodes as means of signal delivery. The signal or waveform, frequency and strength were created to match the characteristics of signals the body generates to help natural healing.
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 treatments using an FDA cleared MedRelief device: (1) a MedRelief SE 55 device set on "pulsed" mode at 10 microsecond burst intervals 4150 Ha, or (2) a MedRelief SE 55 device set on "continuous" mode at 4150 Hz. Subjects will wear the device on target foot each night for a minimum of 6 hours over a two week (15 day treatment)period.
Subjects will complete a daily pain diary, medication form, and device use form. Subject global assessments and physician global assessments will occur at baseline, study visits Day 7, Day 15 and Day 21 (end of study).
Response to therapy will include pain reduction, improvement in sensation, improved response to vibratory stimulation and reduction of edema in study subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
Keywords
diabetes mellitus, neuropathy, distal symmetric polyneuropathy, pulsed electric fild
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1, 2
Arm Type
Active Comparator
Arm Description
Pulse MedRelief SE 55
Continuous MedRelief SE 55
Intervention Type
Device
Intervention Name(s)
MedRelief SE 55
Intervention Description
4150 Hz signal continuous or pulse, high intensity, high modulation for 6 hours each night during treatment phase
Primary Outcome Measure Information:
Title
Pain reduction in diabetic patients with chronic diabetic neuropathy
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
Improvement in sensation and overall foot condition
Time Frame
Day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy M Sprague, MD
Organizational Affiliation
Nephrology and Rheumatology Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nephrology and Rheumatology Associates
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Pulsing Electrical Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study
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