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Study of PEMF to Evaluate VPT and Thermal Sensory in Subjects With Diabetic Peripheral Neuropathy

NCT03077893 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-07-30

Study results available
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Summary

A study to demonstrate the effectiveness of PEMF treatment compared to sham treatment in changing Vibration Perception Threshold (VPT) and Thermal Sensory (QST) in patients with diabetic peripheral neuropathy (DPN) when treatment is administered twice daily through 120-day period.

Conditions

  • Diabetic Peripheral Neuropathy

Interventions

DEVICE

Active Provant Therapy System

Treatment with active Provant Therapy System

DEVICE

Inactive (sham) Provant Therapy System

Treatment with Inactive (sham) Provant Therapy System

Sponsors & Collaborators

  • Regenesis Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Arthur Tallas, DPM · Associated Foot & Ankle Specialists, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2017-12-26
Completion
2017-12-26
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 NCT03077893 on ClinicalTrials.gov