Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD

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.

Study Overview

• Status: Terminated
• Conditions: PAD - Peripheral Arterial Disease; PVD- Peripheral Vascular Disease
• Intervention / Treatment: Device: Tennant Biomodulator-Pro™ Device

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford Advanced Wound Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Electrical Stimulation First, then Sham Stimulation; Treat the patient's wound area: Place self-adhesive, conductive electrode pads on either side of the wound on the skin where the pads are not placed in the open wound itself, but rather in the surrounding area with one pad on each side of the wound. Connect the pads to the lead wire to the Avazzia device. Turn on the Avazzia device and change modes to the RSI mode. Increase power to maximum comfortable power level for the patient. If the patient cannot feel the output, then increase power to 250. Instruct the patient to reduce the power level if it begins to feel too strong. (sometimes as the microstimulation is applied, the tissue will become more sensitive to the stimulation. In this case the power should be reduced for patient comfort.) Allow to run unattended for 15 minutes. Take a picture of the pad placement and display on the device to document location, power setting, and treatment mode while the treatment is running for the 15 minutes.	Device: Tennant Biomodulator-Pro™ Device; Tennant Biomodulator-Pro™ conductive electrode pads will be placed on both sides of the wound. The device will either deliver electrical stimulation or no stimulation depending on treatment period.
Sham Comparator: Sham Electrical Stimulation First, then Electrical Stimulation; Treat the patient's wound area: Place self-adhesive, conductive electrode pads on either side of the wound on the skin where the pads are not placed in the open wound itself, but rather in the surrounding area with one pad on each side of the wound. Connect the pads to the lead wire to the Avazzia device. Turn on the Avazzia device and change modes to the RSI mode. Increase power to maximum comfortable power level for the patient. If the patient cannot feel the output, then increase power to 250. Instruct the patient to reduce the power level if it begins to feel too strong. (sometimes as the microstimulation is applied, the tissue will become more sensitive to the stimulation. In this case the power should be reduced for patient comfort.) Allow to run unattended for 15 minutes. Take a picture of the pad placement and display on the device to document location, power setting, and treatment mode while the treatment is running for the 15 minutes.	Device: Tennant Biomodulator-Pro™ Device; Tennant Biomodulator-Pro™ conductive electrode pads will be placed on both sides of the wound. The device will either deliver electrical stimulation or no stimulation depending on treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Tissue Perfusion	To compare wound tissue perfusion following treatment vs placebo (as measured using the HyperMed HyperView device)	Day 7 of the respective treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial Biopsies	To compare bacterial burden at the wound site following treatment vs placebo (measured in cells per gram of wound tissue from quantitative deep tissue swab)	From time of randomization up until wound healing or 3 weeks, whichever came first
Percent Change in Wound Area as a Measure of Healing Rate	To compare rate of wound healing following treatment vs placebo (measured as percentage change in wound area).	Day 7 of the respective treatment period
Pain Score	To compare patient pain at the wound site following treatment vs placebo, measured on a numerical 0-10 visual scale (0 = no pain, 10 = worst pain imaginable)	Day 7 of the respective treatment period

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Geoffrey C Gurtner, MD, Stanford University School of Medicine- Plastic & Reconstructive Surgery

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Physiological Effects of Drugs; Immunologic Factors; Immunomodulating Agents
• Other Study ID Numbers: 45628

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No