Status:
TERMINATED
Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD
Lead Sponsor:
Stanford University
Conditions:
PAD - Peripheral Arterial Disease
PVD- Peripheral Vascular Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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.
Detailed Description
Investigators hope to learn if micro-current stimulation to a chronic, non-healing wound can be lead to healing. Perfusion studies and bacterial measurements will be assessed before and after treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04313985
Start Date
August 1 2019
End Date
March 31 2022
Last Update
June 1 2023
Active Locations (1)
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1
Stanford Advanced Wound Care Center
Redwood City, California, United States, 94063