PAD - Peripheral Arterial DiseaseNCT04313985
Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD
A study testing Tennant Biomodulator-Pro™ Device in people with PAD - Peripheral Arterial Disease and PVD- Peripheral Vascular Disease, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PAD - Peripheral Arterial Disease, PVD- Peripheral Vascular Disease
- What is being tested?
- Tennant Biomodulator-Pro™ Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Advanced Wound Care Center
Redwood City, California, 94063
About this study
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.
Read the 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.
- Being tested
- Tennant Biomodulator-Pro™ Device
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tennant Biomodulator-Pro™ DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrical Stimulation First, then Sham Stimulation | Active comparator | 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. Receives: Device: Tennant Biomodulator-Pro™ Device |
| Sham Electrical Stimulation First, then Electrical Stimulation | Sham comparator | 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. Receives: Device: Tennant Biomodulator-Pro™ Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Tissue Perfusion
To compare wound tissue perfusion following treatment vs placebo (as measured using the HyperMed HyperView device)
Measured: Day 7 of the respective treatment period
Secondary outcomes (3)
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).
Measured: Day 7 of the respective treatment period
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)
Measured: From time of randomization up until wound healing or 3 weeks, whichever came first
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)
Measured: Day 7 of the respective treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Aug 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Why it stopped: PI relocated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PAD - Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffrey C Gurtner, MD, Principal investigator, Stanford University School of Medicine- Plastic & Reconstructive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313985
- Sponsor's protocol ID
- 45628
- Status last verified
- May 2023
- First submitted
- 1 Aug 2019
- Last updated
- 1 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD
- ClinicalTrials.gov ID
- NCT04313985
- Acronym / sponsor ID
- 45628
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI relocated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Posted 1 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical Stimulation First, then Sham Stimulation | Active comparator | Device: Tennant Biomodulator-Pro™ DeviceTreat 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. |
| Sham Electrical Stimulation First, then Electrical Stimulation | Sham comparator | Device: Tennant Biomodulator-Pro™ DeviceTreat 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tennant Biomodulator-Pro™ DeviceTennant 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. | Device | Electrical Stimulation First, then Sham Stimulation, Sham Electrical Stimulation First, then Electrical Stimulation |
Primary outcome
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)
3 secondary outcomes
Percent Change in Wound Area as a Measure of Healing Rate
Time frame: Day 7 of the respective treatment period
Bacterial Biopsies
Time frame: From time of randomization up until wound healing or 3 weeks, whichever came first
Pain Score
Time frame: Day 7 of the respective treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for PAD - Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey C Gurtner, MD principal investigator
Stanford University School of Medicine- Plastic & Reconstructive Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tennant Biomodulator-Pro™ Device in people with PAD - Peripheral Arterial Disease and PVD- Peripheral Vascular Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Tissue Perfusion (time frame: Day 7 of the respective treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.