An Evaluation of an SCCD on the Symptomatology of Painful DPN

Status Recruiting

Clinical Trial Summary

This is a controlled trial to evaluate the efficacy of an Sequential Contraction Compression Device (SCCD) on the symptomatology of Painful Diabetic Neuropathy. Subjects will be divided into a control group where they will be monitored while continuing with their current treatment regimen and into a treatment group where they will continue with their current regimen and have SCCD therapy added. Subjects will be evaluated for Subjective Pain levels, quality of life, breakthrough drug use, sleep levels, and objectively with a Quantitative Sensory Testing device. The trial duration is 30 days.

Clinical Trial Description

This is a controlled trial of 30 days duration to evaluate the efficacy of an Sequential Contraction Compression Device (SCCD) on the symptomatology of Painful Diabetic Neuropathy. Subjects will have to have been on a sustained drug regimen for more than 30 days and have an average pain level of 4 on a VAS. Subjects will be divided into a control group where they will be monitored while continuing with their current treatment regimen and into a treatment group where they will continue with their current regimen and have SCCD therapy added. Patients will be asked to use the SCCD device daily on both their legs. Subjects will be evaluated for Subjective Pain levels using a Visual Analog Scale, quality of life using various questionnaires, breakthrough drug use in a daily log, sleep levels i.e. how many consecutive hours of sleep, and objectively with a Quantitative Sensory Testing device. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03331614
Study type	Interventional
Source	Rosenblum, Jonathan I., DPM
Contact	Jonathan Rosenblum, DPM
Phone	720-744-3222
Email	diabfootman@gmail.com
Status	Recruiting
Phase	N/A
Start date	October 15, 2017
Completion date	April 30, 2018

View Details

See also
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