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

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ClinicalTrials.gov Identifier: NCT03843307
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : July 14, 2020
Sponsor:
Collaborators:
University of Texas Southwestern Medical Center
Lawrence A. Lavery, DPM, MPH
Kathryn Davis, Ph.D.
Information provided by (Responsible Party):
Avazzia, Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Perfusion; Complications Wound; Foot Device: Avazzia Tennant Biomodulator® PRO Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to Evaluate the Tennant Biomodulator® PRO Device Designed by AVAZZIA Effects on Perfusion
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

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.




Primary Outcome Measures :
  1. Improvement in perfusion up to 3 hours [ Time Frame: 3 hours ]
    Change in skin perfusion will be assessed by Skin Perfusion Pressure Test (SPP)

  2. Improvement in perfusion up to 3 hours [ Time Frame: 3 hours ]
    Change in skin perfusion will be assessed by Hyperspectral Imaging (HSI)


Secondary Outcome Measures :
  1. Duration of BEST-induced perfusion effects [ Time Frame: 3 hours ]
    To compare the duration of BEST™ (Bio-Electric Stimulation Technology) induced perfusion effects

  2. 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



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843307


Contacts
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Contact: Tammy Lahutsky 214-575-2820 tlahutsky@avazzia.com

Locations
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United States, Texas
University of Texas Southwestern Medical Center, Department of Plastic Surgery Recruiting
Dallas, Texas, United States, 75390
Contact: Lawrence A Lavery, DPM, MPH    214-645-7900      
Sponsors and Collaborators
Avazzia, Inc
University of Texas Southwestern Medical Center
Lawrence A. Lavery, DPM, MPH
Kathryn Davis, Ph.D.
Investigators
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Principal Investigator: Lawrence A Lavery, DPM, MPH University of Texas Southwestern Medical Center, Department of Plastic Surgery
Publications:
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Responsible Party: Avazzia, Inc
ClinicalTrials.gov Identifier: NCT03843307    
Other Study ID Numbers: STU 042018-005
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020

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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
Keywords provided by Avazzia, Inc:
Electrical stimulation
Perfusion
Foot wound
Foot pain
Additional relevant MeSH terms:
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Foot Injuries
Leg Injuries
Wounds and Injuries
Immunologic Factors
Physiological Effects of Drugs