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

• ClinicalTrials.gov Identifier: NCT04313985
• Recruitment Status: Terminated
• First Posted: March 18, 2020
• Last Update Posted: February 9, 2023
• Sponsor: Stanford University
• Information provided by (Responsible Party): Geoffrey C. Gurtner, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
PAD - Peripheral Arterial Disease; PVD- Peripheral Vascular Disease	Device: Tennant Biomodulator-Pro™ Device	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Both the participant and the care provider will be masked as to what treatment the participant is receiving during each study visit. Only the study coordinator will know which treatment is being conducted.
• Primary Purpose: Treatment
• Official Title: Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD
• Actual Study Start Date: August 1, 2019
• Actual Primary Completion Date: March 31, 2022
• Actual Study Completion Date: March 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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 not depending on what treatment group the participant is in.
Sham Comparator: Sham 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 not depending on what treatment group the participant is in.

Outcome Measures

Primary Outcome Measures :

1. End of Treatment [ Time Frame: 2 Weeks Total ]
   To compare wound tissue perfusion following treatment vs placebo (as measured using the HyperMed HyperView device)

Secondary Outcome Measures :

1. Healing Rate [ Time Frame: From time of randomization up until wound healing or 3 weeks, whichever came first ]
   To compare rate of wound healing following treatment vs placebo (measured as percentage decrease in wound size)
2. Bacterial Biopsies [ Time Frame: From time of randomization up until wound healing or 3 weeks, whichever came first ]
   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)
3. Pain Assessment [ Time Frame: From time of randomization up until wound healing or 3 weeks, whichever came first ]
   To compare patient pain at the wound site following treatment vs placebo (measured on a numerical 0-10 visual scale)

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, California

Stanford Advanced Wound Care Center

Redwood City, California, United States, 94063

Sponsors and Collaborators

Stanford University

Investigators

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

More Information

• Responsible Party: Geoffrey C. Gurtner, Principal Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT04313985
• Other Study ID Numbers: 45628
• First Posted: March 18, 2020
• Last Update Posted: February 9, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Immunologic Factors; Physiological Effects of Drugs