PAD - Peripheral Arterial Disease, PVD- Peripheral Vascular Disease
Conditions
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.
Interventions
DEVICETennant 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.
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Tissue Perfusion | Day 7 of the respective treatment period | To compare wound tissue perfusion following treatment vs placebo (as measured using the HyperMed HyperView device) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Wound Area as a Measure of Healing Rate | Day 7 of the respective treatment period | To compare rate of wound healing following treatment vs placebo (measured as percentage change in wound area). |
| Bacterial Biopsies | 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) |
| Pain Score | Day 7 of the respective treatment period | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Electrical Stimulation First, Then Sham Stimulation | Sham Stimulation First, the Electrical Stimulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Pain Score | 0 score on a scale STANDARD_DEVIATION 0 | 2.5 score on a scale STANDARD_DEVIATION 3.536 | 1.25 score on a scale STANDARD_DEVIATION 2.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
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
Population: Data were not collected for the outcome measure.
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)
Time frame: From time of randomization up until wound healing or 3 weeks, whichever came first
Population: Data were not collected for this outcome measure.
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)
Time frame: Day 7 of the respective treatment period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Electrical Stimulation | Pain Score | 0 score on a scale |
| Sham Electrical Stimulation | Pain Score | 1 score on a scale |
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).
Time frame: Day 7 of the respective treatment period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Electrical Stimulation | Percent Change in Wound Area as a Measure of Healing Rate | -31 percentage change |
| Sham Electrical Stimulation | Percent Change in Wound Area as a Measure of Healing Rate | -52 percentage change |