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A Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers

NCT00761176 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-01-05

Study results available
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Summary

The objective of this study is to compare the reduction in wound surface areas between patients with diabetic ulcers utilizing Provant's pulsed radio frequency energy therapy (PRFE) as an adjunct to standardized basic wound care to those utilizing standardized basic wound care alone.

Conditions

  • Diabetic Foot Ulcers

Interventions

DEVICE

The Provant Therapy System

The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.

Sponsors & Collaborators

  • Regenesis Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Mike Wilson, DPM · Winston - Salem Outpatient Clinic, WG Hefner VAMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-03-31
Completion
2011-03-31

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 NCT00761176 on ClinicalTrials.gov