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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2021-04-12

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.

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Detailed Description

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Conditions

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Perfusion; Complications Wound; Foot

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electrical stimulation

Group Type EXPERIMENTAL

Avazzia Tennant Biomodulator® PRO

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No