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

Primary Purpose

Perfusion; Complications, Wound; Foot

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Avazzia Tennant Biomodulator® PRO
Sponsored by
Avazzia, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perfusion; Complications focused on measuring Electrical stimulation, Perfusion, Foot wound, Foot pain

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Texas Southwestern Medical Center, Department of Plastic Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrical stimulation

Arm Description

Outcomes

Primary Outcome Measures

Improvement in perfusion up to 3 hours
Change in skin perfusion will be assessed by Skin Perfusion Pressure Test (SPP)
Improvement in perfusion up to 3 hours
Change in skin perfusion will be assessed by Hyperspectral Imaging (HSI)

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2019
Last Updated
August 25, 2021
Sponsor
Avazzia, Inc
Collaborators
University of Texas Southwestern Medical Center, Lawrence A. Lavery, DPM, MPH, Kathryn Davis, Ph.D.
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1. Study Identification

Unique Protocol Identification Number
NCT03843307
Brief Title
Avazzia-University of Texas Southwestern Medical Center-Tennant Biomodulator® PRO Perfusion Study
Official Title
Study to Evaluate the Tennant Biomodulator® PRO Device Designed by AVAZZIA Effects on Perfusion
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to difficulties with enrollment which were complicated by pauses to clinical research from COVID, The University of Texas Southwestern has decided not to pursue the continuation of this study.
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
April 12, 2021 (Actual)
Study Completion Date
April 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avazzia, Inc
Collaborators
University of Texas Southwestern Medical Center, Lawrence A. Lavery, DPM, MPH, Kathryn Davis, Ph.D.

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perfusion; Complications, Wound; Foot
Keywords
Electrical stimulation, Perfusion, Foot wound, Foot pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Avazzia Tennant Biomodulator® PRO
Intervention Description
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 Measure Information:
Title
Improvement in perfusion up to 3 hours
Description
Change in skin perfusion will be assessed by Skin Perfusion Pressure Test (SPP)
Time Frame
3 hours
Title
Improvement in perfusion up to 3 hours
Description
Change in skin perfusion will be assessed by Hyperspectral Imaging (HSI)
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Duration of BEST-induced perfusion effects
Description
To compare the duration of BEST™ (Bio-Electric Stimulation Technology) induced perfusion effects
Time Frame
3 hours
Title
Changes in reported pain after BEST™ (Bio-Electric Stimulation Technology) administration, at the point perfusion returns to baseline, and at 24 hours after treatment
Description
Pain will be assessed with the Visual Analog Scale (VAS) labeled from '0': no pain to '10': worst pain imaginable
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence A Lavery, DPM, MPH
Organizational Affiliation
University of Texas Southwestern Medical Center, Department of Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center, Department of Plastic Surgery
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24049559
Citation
Thakral G, Lafontaine J, Najafi B, Talal TK, Kim P, Lavery LA. Electrical stimulation to accelerate wound healing. Diabet Foot Ankle. 2013 Sep 16;4. doi: 10.3402/dfa.v4i0.22081.
Results Reference
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PubMed Identifier
9798171
Citation
Peters EJ, Armstrong DG, Wunderlich RP, Bosma J, Stacpoole-Shea S, Lavery LA. The benefit of electrical stimulation to enhance perfusion in persons with diabetes mellitus. J Foot Ankle Surg. 1998 Sep-Oct;37(5):396-400; discussion 447-8. doi: 10.1016/s1067-2516(98)80048-3.
Results Reference
background
PubMed Identifier
29738296
Citation
Nair HKR. Microcurrent as an adjunct therapy to accelerate chronic wound healing and reduce patient pain. J Wound Care. 2018 May 2;27(5):296-306. doi: 10.12968/jowc.2018.27.5.296.
Results Reference
background
PubMed Identifier
29357520
Citation
Andrushko JW, Lanovaz JL, Bjorkman KM, Kontulainen SA, Farthing JP. Unilateral strength training leads to muscle-specific sparing effects during opposite homologous limb immobilization. J Appl Physiol (1985). 2018 Apr 1;124(4):866-876. doi: 10.1152/japplphysiol.00971.2017. Epub 2017 Dec 14.
Results Reference
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Avazzia-University of Texas Southwestern Medical Center-Tennant Biomodulator® PRO Perfusion Study

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