Perfusion; Complications, Wound; Foot
Conditions
Keywords
Electrical stimulation, Perfusion, Foot wound, Foot pain
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.
Interventions
DEVICEAvazzia 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.
Sponsors
University of Texas Southwestern Medical Center
Lawrence A. Lavery, DPM, MPH
Kathryn Davis, Ph.D.
Avazzia, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in perfusion up to 3 hours | 3 hours | Change in skin perfusion will be assessed by Skin Perfusion Pressure Test (SPP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of BEST-induced perfusion effects | 3 hours | 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 | 24 hours | Pain will be assessed with the Visual Analog Scale (VAS) labeled from '0': no pain to '10': worst pain imaginable |
Countries
United States
Outcome results
None listed