Status:
TERMINATED
Avazzia-University of Texas Southwestern Medical Center-Tennant Biomodulator® PRO Perfusion Study
Lead Sponsor:
Avazzia, Inc
Collaborating Sponsors:
University of Texas Southwestern Medical Center
Lawrence A. Lavery, DPM, MPH
Conditions:
Perfusion; Complications
Wound; Foot
Eligibility:
All Genders
18-89 years
Phase:
NA
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), o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03843307
Start Date
April 24 2019
End Date
April 12 2021
Last Update
August 30 2021
Active Locations (1)
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1
University of Texas Southwestern Medical Center, Department of Plastic Surgery
Dallas, Texas, United States, 75390