An interventional study of Tennant Biomodulator-Pro™ Device in PAD - Peripheral Arterial Disease and PVD- Peripheral Vascular Disease, sponsored by Stanford University. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
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.
1,025 studies on the registry are indexed under Peripheral Vascular Diseases; 123 are open to participants now.
This study's enrollment of 4 is below the median of 70 across 729 interventional studies indexed under Peripheral Vascular Diseases.
Browse Peripheral Vascular Diseases studies →Stanford University is the lead sponsor of 2,162 studies on the registry; 429 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
Wound Tissue Perfusion
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
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).
Time frame: 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)
Time frame: 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)
Time frame: Day 7 of the respective treatment period
| Milestone | Electrical Stimulation First, Then Sham Stimulation | Sham Stimulation First, the Electrical Stimulation |
|---|---|---|
| Started | 2 | 2 |
| Completed | 2 | 2 |
| Not completed | 0 | 0 |
| Milestone | Electrical Stimulation First, Then Sham Stimulation | Sham Stimulation First, the Electrical Stimulation |
|---|---|---|
| Started | 2 | 2 |
| Completed | 2 | 2 |
| Not completed | 0 | 0 |
| Milestone | Electrical Stimulation First, Then Sham Stimulation | Sham Stimulation First, the Electrical Stimulation |
|---|---|---|
| Started | 2 | 2 |
| Completed | 2 | 2 |
| Not completed | 0 | 0 |
To compare wound tissue perfusion following treatment vs placebo (as measured using the HyperMed HyperView device)
No measurements were reported for this outcome.
To compare rate of wound healing following treatment vs placebo (measured as percentage change in wound area).
| percentage change | Electrical Stimulation | Sham Electrical Stimulation |
|---|---|---|
| Percent Change in Wound Area as a Measure of Healing Rate | -31 (-71 to 19) | -52 (-65 to 38) |
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)
No measurements were reported for this outcome.
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)
| score on a scale | Electrical Stimulation | Sham Electrical Stimulation |
|---|---|---|
| Pain Score | 0 (0 to 1.75) | 1 (0 to 1.25) |
Collected over 3 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Electrical Stimulation | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Sham Electrical Stimulation | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Electrical Stimulation First, Then Sham Stimulation | Sham Stimulation First, the Electrical Stimulation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 0 | 1 |
| >=65 years | 1 | 2 | 3 |
| Sex: Female, Male(Participants) | Electrical Stimulation First, Then Sham Stimulation | Sham Stimulation First, the Electrical Stimulation | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 2 | 2 | 4 |
| Race and Ethnicity Not Collected(Participants) | Electrical Stimulation First, Then Sham Stimulation | Sham Stimulation First, the Electrical Stimulation | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Electrical Stimulation First, Then Sham Stimulation | Sham Stimulation First, the Electrical Stimulation | Total |
|---|---|---|---|
| United States | 2 | 2 | 4 |
| Pain Score(score on a scale) | Electrical Stimulation First, Then Sham Stimulation | Sham Stimulation First, the Electrical Stimulation | Total |
|---|---|---|---|
| Mean | 0 ± 0 | 2.5 ± 3.536 | 1.25 ± 2.5 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peripheral Vascular Diseases →