Effect of Pulsing Electrical Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study

Diabetic Peripheral Neuropathy Clinical Trial

— DPN  

Official title:

A Phase IV Clinical Trial. Effect of Pulsing Electromagnetic Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614341
• Other study ID #: 600-001
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2008
• Last updated: February 12, 2008
• Start date: May 2006
• Est. completion date: January 2008

Study information

• Verified date: January 2008
• Source: MedRelief
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Device:
• MedRelief SE 55
4150 Hz signal continuous or pulse, high intensity, high modulation for 6 hours each night during treatment phase

Locations

Country	Name	City	State
United States	Nephrology and Rheumatology Associates	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
MedRelief

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction in diabetic patients with chronic diabetic neuropathy		Day 21	Yes
Secondary	Improvement in sensation and overall foot condition		Day 21	Yes