Clinical trial NCT04313985: Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD
Official title: Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: PAD - Peripheral Arterial Disease
PVD- Peripheral Vascular Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wound Tissue Perfusion
timeFrame: Day 7 of the respective treatment period
Secondary outcomes:
measure: Percent Change in Wound Area as a Measure of Healing Rate
timeFrame: Day 7 of the respective treatment period
measure: Bacterial Biopsies
timeFrame: From time of randomization up until wound healing or 3 weeks, whichever came first
measure: Pain Score
timeFrame: Day 7 of the respective treatment period
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Advanced Wound Care Center
state: California
Study officials:
affiliation: Stanford University School of Medicine- Plastic & Reconstructive Surgery
name: Geoffrey C Gurtner, MD
role: PRINCIPAL_INVESTIGATOR
References: