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Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy

NCT01214590 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2011-04-13

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and the preliminary efficacy of treatment by the VascuActive device on peripheral diabetic neuropathy, and to correlate this effect with physiologic changes.

Patients will undergo a 4-week period of home treatment by the VascuActive device, and will be monitored during this period and during a two-month follow-up period for the efficacy of the device in reducing neuropathic pain, sensation impairment and other signs and symptoms.

Conditions

  • Diabetic Neuropathy, Painful

Interventions

DEVICE

VascuActive device

self treatment by the patient, for 4 weeks, 3 sessions per day, approximately 30 minutes per session

Sponsors & Collaborators

  • VascuActive LTD

    lead INDUSTRY

Principal Investigators

  • Arie Bass, Prof. · Assaf-Harofeh Medical Center

  • Robert Slater, Dr. · Assaf-Harofeh Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-02-29

Countries

  • Israel

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 NCT01214590 on ClinicalTrials.gov