Electrical Stimulation for Improving Balance in Diabetes

Completed · Not applicable · Has a placebo group

Conditions studied: Diabetic Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT02337218

Run by

University of Texas Southwestern Medical Center

People needed

28

Starts

2014-11-01

Expected to finish

2017-03-01

Last updated by the study team

2020-08-14

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women (non pregnant) 18 years old or above
• Diagnosed for Diabetes Mellitus (type 2)* and ADA criteria Diabetes
• Evidence of peripheral neuropathy on neurologic examination
• Identified by our clinical staff examination and based on the criteria explained in -ADA statement
• Agreed to participate in this study and comply with instruction

You may not qualify if…

• Amputation and active ulcers or infection
• Cognitive deficits
• MMSE score of 24 or lower
• Unable to stand for more than 5 minutes (including symptomatic orthostatic hypotension or pain)
• Any clinically significant orthopedic, muscular, or peripheral vascular disorders that affect balance
• Alcohol or substance abuse within 6 months or major psychiatric disorder

Where it is running

• UT Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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