Back to resultsElectrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD
Primary Purpose
PAD - Peripheral Arterial Disease, PVD- Peripheral Vascular Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tennant Biomodulator-Pro™ Device
Sponsored by
About this trial
This is an interventional treatment trial for PAD - Peripheral Arterial Disease
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
Sites / Locations
- Stanford Advanced Wound Care Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Electrical Stimulation First, then Sham Stimulation
Sham Electrical Stimulation First, then Electrical Stimulation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Wound Tissue Perfusion
To compare wound tissue perfusion following treatment vs placebo (as measured using the HyperMed HyperView device)
Secondary Outcome Measures
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).
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04313985
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
PI relocated
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PAD - Peripheral Arterial Disease, PVD- Peripheral Vascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electrical Stimulation First, then Sham Stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham Electrical Stimulation First, then Electrical Stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Tennant Biomodulator-Pro™ Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound Tissue Perfusion
Description
To compare wound tissue perfusion following treatment vs placebo (as measured using the HyperMed HyperView device)
Time Frame
Day 7 of the respective treatment period
Secondary Outcome Measure Information:
Title
Percent Change in Wound Area as a Measure of Healing Rate
Description
To compare rate of wound healing following treatment vs placebo (measured as percentage change in wound area).
Time Frame
Day 7 of the respective treatment period
Title
Bacterial Biopsies
Description
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)
Time Frame
From time of randomization up until wound healing or 3 weeks, whichever came first
Title
Pain Score
Description
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)
Time Frame
Day 7 of the respective treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey C Gurtner, MD
Organizational Affiliation
Stanford University School of Medicine- Plastic & Reconstructive Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Advanced Wound Care Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD
We'll reach out to this number within 24 hrs