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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tennant Biomodulator-Pro™ Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Bacterial Biopsies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey C Gurtner, MD | Stanford University School of Medicine- Plastic & Reconstructive Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Advanced Wound Care Center | Redwood City | California | 94063 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Electrical Stimulation First, Then Sham Stimulation | Tennant Biomodulator-Pro™ conductive electrode pads placed on both sides of the wound, delivering electrical stimulation or no stimulation in the respective study period. |
| FG001 | Sham Stimulation First, the Electrical Stimulation | Tennant Biomodulator-Pro™ conductive electrode pads placed on both sides of the wound, delivering electrical stimulation or no stimulation in the respective study period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (1 Week) |
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| Treatment Period 2 (1 Week) |
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| Follow-up Period (1 Week) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Electrical Stimulation First, Then Sham Stimulation | Tennant Biomodulator-Pro™ conductive electrode pads placed on both sides of the wound, delivering electrical stimulation or no stimulation in the respective study period. |
| BG001 | Sham Stimulation First, the Electrical Stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wound Tissue Perfusion | To compare wound tissue perfusion following treatment vs placebo (as measured using the HyperMed HyperView device) | Data were not collected for the outcome measure. | Posted | Day 7 of the respective treatment period |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electrical Stimulation | Tennant Biomodulator-Pro™ conductive electrode pads placed on both sides of the wound delivering electrical stimulation. |
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This study fell far short of it's planned enrollment size and failed to achieve statistical power.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Geoffrey Gurtner | Stanford University | (520) 626-2222 | gurtner@surgery.arizona.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2018 | Mar 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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 |
| 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 |
| NOT COMPLETED |
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| NOT COMPLETED |
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Tennant Biomodulator-Pro™ conductive electrode pads placed on both sides of the wound, delivering electrical stimulation or no stimulation in the respective study period. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Pain Score | Measured on a numerical 0-10 visual scale (0 = no pain, 10 = worst pain imaginable) | Mean | Standard Deviation | score on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | percentage change | Day 7 of the respective treatment period |
|
|
|
| Secondary | 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) | Data were not collected for this outcome measure. | Posted | From time of randomization up until wound healing or 3 weeks, whichever came first |
|
|
| Secondary | 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) | Posted | Median | Inter-Quartile Range | score on a scale | Day 7 of the respective treatment period |
|
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Sham Electrical Stimulation | Tennant Biomodulator-Pro™ conductive electrode pads placed on both sides of the wound delivering no stimulation. | 0 | 4 | 0 | 4 | 0 | 4 |
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