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

Not Applicable

Terminated

• Conditions: Wound; Foot; Perfusion; Complications

• Registration Number: NCT03843307
• Lead Sponsor: Avazzia, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-18
• Study Start: 2019-04-24
• Primary Completion: 2021-04-12
• Study Completion: 2021-04-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement in perfusion up to 3 hours	3 hours	Change in skin perfusion will be assessed by Hyperspectral Imaging (HSI)

Secondary Outcome Measures

Name	Time	Method
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
Duration of BEST-induced perfusion effects	3 hours	To compare the duration of BEST™ (Bio-Electric Stimulation Technology) induced perfusion effects

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center, Department of Plastic Surgery; 🇺🇸 Dallas, Texas, United States