NCT00614341

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
Last Updated

February 13, 2008

Status Verified

January 1, 2008

Enrollment Period

1.6 years

First QC Date

January 30, 2008

Last Update Submit

February 12, 2008

Conditions

Diabetic Peripheral Neuropathy

Keywords

diabetes mellitusneuropathydistal symmetric polyneuropathypulsed electric fild

Outcome Measures

Primary Outcomes (1)

  • Pain reduction in diabetic patients with chronic diabetic neuropathy

    Day 21

Secondary Outcomes (1)

  • Improvement in sensation and overall foot condition

    Day 21

Study Arms (1)

1, 2

ACTIVE COMPARATOR

1. Pulse MedRelief SE 55 2. Continuous MedRelief SE 55

Device: MedRelief SE 55

Interventions

MedRelief SE 55DEVICE

4150 Hz signal continuous or pulse, high intensity, high modulation for 6 hours each night during treatment phase

1, 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology and Rheumatology Associates

Augusta, Georgia, 30909, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Amy M Sprague, MD

    Nephrology and Rheumatology Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 30, 2008

First Posted

February 13, 2008

Study Start

May 1, 2006

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

February 13, 2008

Record last verified: 2008-01

Locations

US(1)