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

August 25, 2021 updated by: Avazzia, Inc

Study to Evaluate the Tennant Biomodulator® PRO Device Designed by AVAZZIA Effects on Perfusion

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center, Department of Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to provide Informed Consent
  • Ankle Brachial Index (ABI) ≥ 0.5 (bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to therapy)
  • Participant is a hospital in-patient for the duration of study procedures
  • One or more chronic lower extremity wounds that are located in the ankle area or below that has persisted a minimum of 30 days prior to the Screening visit
  • 18 years of age or older

Exclusion Criteria:

  • Unable to provide informed consent
  • <18 years of age
  • Participant has a demand-type cardiac pacemaker, implanted defibrillator or other implanted metallic or electronic device.
  • Participant has untreated osteomyelitis
  • Participant has active cellulitis
  • Participant has active charcot
  • Is pregnant or plans to become pregnant
  • Is nursing or actively lactating
  • Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the participant's ability to provide informed consent, participate in the study protocol including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Electrical stimulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in perfusion up to 3 hours
Time Frame: 3 hours
Change in skin perfusion will be assessed by Skin Perfusion Pressure Test (SPP)
3 hours
Improvement in perfusion up to 3 hours
Time Frame: 3 hours
Change in skin perfusion will be assessed by Hyperspectral Imaging (HSI)
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of BEST-induced perfusion effects
Time Frame: 3 hours
To compare the duration of BEST™ (Bio-Electric Stimulation Technology) induced perfusion effects
3 hours
Changes in reported pain after BEST™ (Bio-Electric Stimulation Technology) administration, at the point perfusion returns to baseline, and at 24 hours after treatment
Time Frame: 24 hours
Pain will be assessed with the Visual Analog Scale (VAS) labeled from '0': no pain to '10': worst pain imaginable
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avazzia, Inc

Collaborators

University of Texas Southwestern Medical Center
Lawrence A. Lavery, DPM, MPH
Kathryn Davis, Ph.D.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 24, 2019

Primary Completion (ACTUAL)

April 12, 2021

Study Completion (ACTUAL)

April 12, 2021

Study Registration Dates

First Submitted

February 7, 2019

First Submitted That Met QC Criteria

February 14, 2019

First Posted (ACTUAL)

February 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 042018-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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