NCT03843307TerminatedNot Applicable
Study to Evaluate the Tennant Biomodulator® PRO Device Designed by AVAZZIA Effects on Perfusion
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Avazzia, Inc
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Improvement in perfusion up to 3 hours
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Improvement in perfusion up to 3 hours
Time Frame: 3 hours
Change in skin perfusion will be assessed by Skin Perfusion Pressure Test (SPP)
Secondary Outcomes
- 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)
- Duration of BEST-induced perfusion effects(3 hours)
Investigators
Study Sites (2)
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