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

Avazzia

Status

Terminated

Conditions

Wound; Foot

Perfusion; Complications

Treatments

Device: Avazzia Tennant Biomodulator® PRO

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03843307

STU 042018-005

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18 to 89 years old

Volunteers

No 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.