Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PAD - Peripheral Arterial Disease
- Sponsor
- Stanford University
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Wound Tissue Perfusion
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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 treatment on this cross-over study. Avazzia microcurrent stimulation was applied to patients with chronic, non-healing wounds in Malaysia and was presented at the international wound conference. In 2015 a poster presentation was presented with a 10-patient case series, and in August 2016, a presentation was made by Dr. Nair, keynote speaker about his 100- patient case series showing that the treatment was safe and effective. Dr. Nair followed this study with a 5-patient study looking at perfusion images using SPY- LUNA imaging equipment. The 5-patient study looked at different methods of applying the therapy.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Wound Tissue Perfusion
Time Frame: Day 7 of the respective treatment period
To compare wound tissue perfusion following treatment vs placebo (as measured using the HyperMed HyperView device)
Secondary Outcomes
- Percent Change in Wound Area as a Measure of Healing Rate(Day 7 of the respective treatment period)
- Bacterial Biopsies(From time of randomization up until wound healing or 3 weeks, whichever came first)
- Pain Score(Day 7 of the respective treatment period)