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Electrical Stimulation for Improving Balance in Diabetes

NCT02337218 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-08-14

Study results available
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Summary

This is a double-blind randomized clinical trial. Both patients and the podiatrist that will evaluate and monitor study patients will be blinded to electrical stimulation application. The manufacturer of the units will be asked to not inform which patient received which unit. Each unit will be coded with a unique identification number, and the manufacturer units revealed their status, placebo or electric stimulation, only at the end of data collection for the last patient. Subsequently, the investigators could match the status of the identification numbers with the corresponding units to start analyzing the data. Patients that receive an activated electrical stimulation unit will receive a standard dose of 50 volts as described above.

The investigator will enroll a cohort of 80 diabetes (type II) patients with peripheral neuropathy (see section 6 for sample size justification). The diagnosis of diabetes mellitus will be based on World Health Organization criteria.(World-Health-Organization 1999). The inclusion and exclusion criteria are described in table III. The clinical assessments are described in table IV. The investigator will discuss the study design, duration, and its risks with potential subjects asked to participate. The participant will be provided with a consent form to read at their leisure. The investigator will be available to answer questions or provide more explanation as requested by potential participants and their family.

Conditions

  • Diabetic Peripheral Neuropathy

Interventions

DEVICE

SENSUS Pain Management System

An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Lawrence A Lavery, DPM, MPH · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-03-31
Completion
2017-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02337218 on ClinicalTrials.gov