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An Evaluation of an SCCD on the Symptomatology of Painful DPN

NCT03331614 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-11-06

No results posted yet for this study

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.

Conditions

  • Painful Diabetic Neuropathy

Interventions

DEVICE

Flowaid FA-100 SCCD

The SCCD is a contained external non invasive electric muscle pump. The device attaches to the rear of the calf with 4 electrodes.

Sponsors & Collaborators

  • Rosenblum, Jonathan I., DPM

    lead INDIV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-10-15
Primary Completion
2018-04-30
Completion
2018-04-30
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 NCT03331614 on ClinicalTrials.gov