MedTrace Logo

Avazzia-University of Texas Southwestern Medical Center-Tennant Biomodulator® PRO Perfusion Study

NCT03843307 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-08-30

No results posted yet for this study

Summary

This study is an open label trial designed to test the effectiveness of the Tennant Biomodulator® PRO electrical stimulation device (Avazzia), which uses BEST™ (Bio-Electric Stimulation Technology), on hospital in-patients to improve perfusion in the treated and contralateral limb.

Conditions

  • Perfusion; Complications
  • Wound; Foot

Interventions

DEVICE

Avazzia Tennant Biomodulator® PRO

High-voltage pulsed current (HVPC) electrical stimulation with Reactions and BEST™ (Bio-Electric Stimulation Technology) microcurrent that measure and change with tissue electrical characteristics.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    collaborator OTHER

  • Lawrence A. Lavery, DPM, MPH

    collaborator UNKNOWN

  • Kathryn Davis, Ph.D.

    collaborator UNKNOWN

  • Avazzia, Inc

    lead INDUSTRY

Principal Investigators

  • Lawrence A Lavery, DPM, MPH · University of Texas Southwestern Medical Center, Department of Plastic Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-04-24
Primary Completion
2021-04-12
Completion
2021-04-12
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03843307 on ClinicalTrials.gov