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

Study Overview
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Brief Summary
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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.

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

Conditions
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Wound; Foot, Perfusion; Complications

Intervention / Treatment
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* Device: Avazzia Tennant Biomodulator® PRO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrical stimulation<br> | Device: Avazzia Tennant Biomodulator® PRO<br>* High-voltage pulsed current (HVPC) electrical stimulation with Reactions and BEST™ (Bio-Electric Stimulation Technology) microcurrent that measure and change with tissue electrical characteristics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in perfusion up to 3 hours | Change in skin perfusion will be assessed by Skin Perfusion Pressure Test (SPP) | 3 hours | 
| Improvement in perfusion up to 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 | 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 | Pain will be assessed with the Visual Analog Scale (VAS) labeled from '0': no pain to '10': worst pain imaginable | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical stimulation, Perfusion, Foot wound, Foot pain