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