Avazzia-University of Texas Southwestern Medical Center-Tennant Biomodulator® PRO Perfusion Study
Stopped early · Not applicable
Conditions studied: Perfusion; Complications, Wound; Foot
In brief
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.
Key facts
- Study ID
- NCT03843307
- Run by
- Avazzia, Inc
- People needed
- 6
- Starts
- 2019-04-24
- Expected to finish
- 2021-04-12
- Last updated by the study team
- 2021-08-30
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Texas Southwestern Medical Center, Department of Plastic Surgery — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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