©2024 Stanford Medicine
Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD
Not Recruiting
Trial ID: NCT04313985
Purpose
The purpose of this study is to apply Avazzia micro-current stimulation to patients with
chronic, non-healing wounds to determine if this therapy is effective in perfusion and
bacterial measurements.
Official Title
Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- Patient has a chronic non-healing wound that has not healed in 30 days in their feet,
legs, lower back or buttocks, but not in their hands because the hands will be used to
verify equipment operation.
- Age ≥18 and ≤70 years
- Wound area is ≥0.5 cm2 and ≤22 cm2
- Willing and able to comply with weekly visits to clinic (e.g., reliable
transportation)
Exclusion Criteria:
- Presence of an electrical implant such as a cardiac pacemaker or neural stimulator
- Patient is currently pregnant, possibly pregnant or breast-feeding User of any
microcurrent device in the past six (6) months prior to enrollment in the study
- Patient is experiencing a medical emergency
- Patient is diagnosed with neuropathy from sources other than diabetes, such as heavy
metal, xenobiotic toxicity
- Patient is diagnosed with Charcot-Marie-Tooth or similar genetically inheritable
neuropathic disease(s)
- Patient is diagnosed with end-stage kidney disease/dialysis or severe kidney
insufficiency
- Patient is diagnosed with malignancies (cancers) undergoing treatment
Intervention(s):
device: Tennant Biomodulator-Pro™ Device
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Shannon Meyer
650-721-1807