The effect of monophasic vs. biphasic current on healing rate and blood flow in people with pressure and neuropathic ulcers.
Background: Endothelial dysfunction due to diabetes may be one reason why at least 15% of people with diabetes will eventually develop a lower extremity ulcer with delayed healing and risk of amputation. Recent evidence shows that skin blood flow may be increased with electrical stimulation if treatment is done in a warm room. However, optimal stimulation waveform is unknown. Optimizing the stimulation waveform may increase healing even more. The purpose of this investigation was to compare two electrical waveforms to determine which increased blood flow blood flow and wound healing more in chronic stage III or IV pressure ulcers and in Wagner stage II neuropathic ulcers when using a warm room.
Materials and Methods: Forty subjects with chronic pressure or neuropathic ulcers were treated at an outpatient wound center. Twenty were people with neuropathic ulcers and twenty with pressure ulcers. Treatment consisted of biphasic or monophasic electrical stimulation up to 20 mA for 30 minutes, 3x/ week for 4 weeks in a 32[degrees]C room. Skin blood flow was measured by a Laser Doppler imager.
Results: Subjects with neuropathic ulcers receiving biphasic current had significantly higher healing rate (70.0% [+ or -] 32.3%) than those receiving. monophasic current (42% [+ or -] 22.3%; p<0.01). Significantly greater increases in blood flow were seen with biphasic current vs. monophasic current in people with pressure ulcers during stimulation at the outside of the wound (p<0.001) and also in subjects with neuropathic ulcers (p<0.05). Biphasic current also demonstrated a significant "carryover effect" or elevated blood flow from the initial test to test 2 and/or 4 for people with pressure ulcers (p<0.049) and neuropathic ulcers (p<0.042).
Conclusion: Both patients with neuropathic and pressure ulcers receiving biphasic current demonstrated greater blood flow and healing rates compared with patients receiving monophasic current when treated in a 32[degrees]C room.
Key Words: Chronic wounds, skin blood flow, electrical stimulation, diabetes
Diabetic ulcers are associated with high morbidity and mortality. Approximately half the persons receiving a diabetes-related amputation will not be alive in 5-years with a mortality rate of 45%, 18% and 55% for neuropathic, neuro-ischemic and ischemic ulcers respectively. (1) A person with diabetes and a pressure wound that is involved in amputation has similar mortality rates than many common types of cancer, (2-6)
Neuropathic and pressure ulcers and long-term diabetic complications are significant social burdens not only due to amputation but also due to quality-of-life reduction. (6) People with diabetes experience substantial wound-healing deficits. These wounds are exaggerated by a prolonged inflammatory reaction with significant impairment in local bacterial invasion control. (7) Evidence suggests that a neuropathic wound's inflammatory stage decreases the repair process and healing rate. (7)
With a high mortality and morbidity rate, the choice of products and treatment modalities available to clinicians treating chronic neuropathic wounds continues to expand. High costs associated with wound care, especially neuropathic wounds, demand that clinicians examine evidence-based interventions and optimally incorporate them into wound care protocols for optimal facilitation to assist the wound's current pathophysiology. (6)
Electrical stimulation has been used as an adjunct for healing many types of chronic wounds in human subjects and animal models as early as the mid-1900s. Literature has shown positive healing rates with electrical stimulation. (8) Controversy exists on the best waveform to be used for wound care, especially for someone with a chronic pressure or neuropathic wound. Two basic waveforms used for wound treatment are direct and pulsatile current. (10) Direct current is defined as unidirectional current flow that must continue uninterrupted for at least I sec and pulsatile current is defined as either unidirectional or bidirectional flow that periodically ceases for a brief, finite period. (10) Pulsatile current can be either monophasic (intermittent and in one direction) or biphasic (intermittent and bidirectional). (10)
Before 1990, no system had been developed to standardize descriptions of electrical currents and waveforms used in electrotherapy. (10) Therefore, descriptions of current types were not available or standardized in the literature. Many of these studies on healing rate and electrical stimulation must be observed with caution.
Use of direct current began in the late 1960s. Over the next 20 years a number of descriptions of treatment of various chronic wounds were published. (11-15) Direct current or monophasic pulsed current are commonly used in wound treatment where polarity of the wound electrode is periodically changed during the course of treatment. Support for polarity changes is based on the concept of galvanotaxis and the influence of biological effects from animal studies. (11-15) A possible antibacterial effect of electrical stimulation was first reported over 30 years ago by Rowley & McKenna using direct current. (15) Since Rowley and McKenna, other studies using direct current demonstrated an attraction of macrophages, neutrophils, fibroblasts, epidermal cells and keratinocytes in a Petri dish or in animals to either the negative or positive electrode. (11-15) These protocols have been implemented in human wound management based on basic science and animal studies with the rationale of a bactericidal or a galvanotaxic effect. Few studies have used voltages similar to that used by Rowley and McKenna because the current would be extremely painful for the patient and might cause severe electrode burns. Low-intensity direct current (LIDC) has been used clinically because of the comfort to the patient. Studies of LIDC have used various protocols as described by earlier research based on galvantaxis. (16-18) Healing rates have ranged from 12.5% per week with pressure ulcers (17) to 20%/week with a mean healing time of 5 weeks in ischemic skin ulcers. (16) The studies did not include people with neuropathic ulcers.
Biphasic and monophasic pulsed current have also been referred to as faradic, alternating, low volt pulsed current or high volt pulsed current. The advantage of pulsed current is that pH does not change at the electrodes so it is much safer to use. Biphasic electrical stimulation healing rates for neuropathic wounds range from 16 to 17.5% per week. (18-22) These studies were done on chronic, non-healing wounds so the healing rate was found to be significant. Monophasic waveforms can either be square or twin-peaked and are traditionally called high-voltage pulsed current (HVPC). Studies using HVPC had various protocols and mixed wound etiologies but demonstrated positive wound healing. (23-27) No studies using a square monophasic pulsed waveform were found in our literature search.
One difficulty comparing clinical outcomes for direct and pulsatile currents is missing parameters within the electrical stimulation protocols of each study. The type of current delivered, current amplitude, pulse frequency and width, electrode size or average current density of the electrode, duty cycle for pulsed currents, phase charge and current density, including calculation of the phase charge delivered to the tissues, treatment time and temperature of the room or skin are important variables for finding the correct "dose" of electrical stimulation for wound healing. (10) Because of the potential of substantial variations in these unreported parameters, one can understand why reported healing rates with electrical stimulation has ranged from none to excellent. Only two studies to date have compared healing rates using a square monophasic vs. a biphasic waveform. (21-22) This is the first study to have looked at these two waveforms, blood flow, and healing rates in people with neuropathic wounds.
The purpose of this study was to compare a square biphasic and monophasic waveform, blood flow and healing rates of chronic stage III and IV pressure ulcers and stage II Wagner scale neuropathic ulcers over four weeks of treatment. Comparisons were made between groups and within groups. Blood flow was measured before, during, and after monophasic or biphasic stimulation currents in a 32[degrees]C room.
SUBJECTS AND METHODS
Subjects were referred to the study by physicians and physical therapists and through advertisements at the medical center. Inclusion criteria were English speaking adults, nonsmoker, having only one wound, and being 40 years of age or older. People with diabetes who had Wagner stage 2 ulcers and people who were free of diabetes and had stage III or IV ulcers based on the National Pressure Ulcer Advisory Panel (NPUAP) staging system were recruited for the study. People with diabetes were evaluated by a physician before the study and were confirmed to have type 2 diabetes. Inclusion criteria for people with diabetes included HgAlc of 7% or under before entering the study and a non-healing Wagner Grade 2neuropathic ulcer on one foot for greater than 4 weeks. Subjects with stage III or IV pressure ulcers were evaluated by a physician before the study to confirm that they did not have diabetes or pre-diabetes. Any subjects with cardiac pacemakers, known peripheral vascular disease disposing them to thrombosis, active osteomyelitis, or who were receiving long term radiation therapy, steroid therapy, or chemotherapy were excluded. They were also excluded if they were pregnant and if they had poor nutritional status per physician from the lab work and prior wound treatment beyond traditional interventions as described below. Since this was an outpatient setting, no patients reported having a specialty mattress at home. People with diabetes did not have orthoses that off-loaded the wound area for the 4 weeks of the study.
Twenty subjects were successfully recruited in both the pressure ulcer and neuropathic ulcer groups. The twenty subjects in each were randomly assigned to receive one of the two types of current; ten subjects with each diagnosis received monophasic electrical current and ten received biphasic electrical current. The patients selected for the study had no healing of their wounds for two months and therefore were their own control subjects.
Treatment for all subjects consisted of traditional dressings. The location of the wounds for people with neuropathic ulcers was on foot or toes. The location of the wounds for people with pressure ulcers was on the greater trochanter, buttock, sacrum or heel areas. The demographic characteristics and location of the wounds of each group are shown in Table I. With one exception, people with pressure ulcers had no significant difference in the duration of ulcers compared with those with neuropathic ulcers: biphasic current group with a pressure ulcer vs. biphasic current group with a neuropathic ulcer, p>.50, biphasic current group with a pressure ulcer vs. monophasic current group with a neuropathic ulcer, p>.17, biphasic current group with a pressure ulcer vs. monophasic current group with a neuropathic ulcer, p>. 18. The only difference among groups in the duration of wounds was found between monophasic current group with a pressure ulcer had a longer duration of wounds vs. monophasic current group with a neuropathic ulcer, p < .01.
Laser Doppler Flow meter
Skin blood flow was measured by a Laser Doppler flow meter produced by Moor Instruments (LDV 304, Oxford, England). The detailed methods are given in detail elsewhere (27-28).
Measurements of wounds and percent healing rate
Wound measurements were recorded during the initial visit, and at 2 and 4 weeks using a computer image produced by the Laser Doppler flow meter. The software provided by Moor Instruments (Laser Doppler Imaging Analyzing software, version 3.1) allows a cursor to be placed on the edge of the wound and traced in a non-geometric image. Once the tracing is complete, the software allows the area and perimeter of the wound to be determined in [cm.sup.2]. Healing rates were expressed as linear healing of wound edge. Linear healing per week is a valid means of comparing wound healing rates in wounds of different dimensions. Linear healing per unit of time should be preferred to measurements of change in wound area to quantify wound healing rates in clinical trials ([DELTA]A/P; A=Area and P=Perimeter). (29)
Skin blood flow was observed in patients receiving monophasic and biphasic current with bouts of 30 minutes of stimulation at two locations; outside and at the center of the wound. Blood flow measurements were taken every 10 minutes over the 30-minute bout. An average of 3 blood flow measurements over 30 minutes was calculated to represent the test. Biphasic and monophasic currents were compared in terms of the blood flow in people with pressure and neuropathic ulcers.
The "carryover effect" is defined as increased blood flow above that measured before the first electrical stimulation treatment was given. Pre-stimulation measurements were taken during each patient visit to determine whether any "carryover" of increased blood flow occurred from the initial testing to week 2 and/or week 4. Pre-stimulation changes were observed from weeks 1-2, 2-4, and 1-4.
The waveform used for electrical stimulation was produced by a Biopac MP 100 (Biopac Systems, Goleta, CA) data analysis system. The system has 16 digital inputs and outputs, a 16-channel analog to digital converter and 2 channels of digital to analog conversion. The sampling speed was 2,000 samples per second at 16 bits of resolution. The waveforms used in the study were either biphasic or monophasic wave with a pulse width of 200 [micro]s, frequency of 30 Hz, and a current up to 20 mA. The voltage to control the Challenge 8000A Stimulator (MPTS, Inc, Tustin, CA) was generated in software through the Acknowledge 3.3 program. The Challenge 8000A Stimulator was used to convert the 5-volt output of the Biopac system to a current controlled stimulus. The current was generated in the Challenge 8000A stimulator and monitored by measuring the voltage drop across a resistor in series with the stimulating electrodes. The Challenge 8000A has an ultra linear Class AB current controlled amplifier in its output stage. The outputs of the stimulator are applied across the skin through two electrodes providing electrical stimulation across a wound
A statistical power analysis was performed a priori to the study. Based on the statistical variance of parameters and other studies, 40 subjects were necessary for our study. All analysis was conducted using SPSS version 12.0 (SPSS Inc, 233 S Wacker Dr, Chicago, IL 60606). Skin blood flow was measured at specific areas around the wound and in the wound. Means and standard deviations were calculated for skin blood flow and healing rate by type of subject, type of current, and measurement time. Statistical analyses included repeated measures ANOVA to compare skin blood flow within groups (time across testing periods) and between groups (types of currents, types of subjects). An alpha level of p<0.05 was used as the criterion for significance.
Three tests were conducted over a 4-week treatment period. They were at the initial test, 2 weeks (6th treatment) and 4 weeks (12th treatment). All testing was conducted in a 32[degrees]C room. The subjects would lie supine on an examination table in a 32[degrees]C room and have two, 2x4 inch bipolar electrodes placed superior and inferior to the wound. The electrodes were connected to the Challenge 8000 electrical stimulation device. The skin was cleaned with alcohol and, if needed, shaved before the electrode was placed. The wound was measured and photographs were also taken with a digital camera. The subject was then scanned by the Laser Doppler flow meter. Once the test started, the Laser Doppler flow meter scanned the wound at 5 and 10 minutes (prestimulation). At 10 minutes, the electrical stimulation was applied. During the 30 minutes of electrical stimulation, the Laser Doppler flow imager recorded measurements at 5, 10, 15, 20, 25, and 30 minutes. At 30 minutes the electrical stimulation was turned off. Post stimulation skin blood flow was recorded for 10 minutes.
Subjects were followed three times per week, preferably on a Monday, Wednesday and Friday, for a total of 12 treatments (including testing). The subject would lie supine in a 32[degrees]C room and the same procedure for electrodes and electrical stimulation were applied as described in the testing section. The duration of the electrical stimulation was 30 minutes with both monophasic and biphasic current and was followed by "traditional treatment." (28-32) Traditional treatment consisted of sharp debridement to remove devitalized tissue, since moist devitalized tissue supports the growth of pathological organisms. (28-32) Dressings used were hydrogel in the wound bed, and 4x4 inch wet-to-dry sterile gauze, (29) followed with either Kerlix or Hypafix tape to keep the dressings in place. (30-33) A moist environment promotes healing. (31) The dressings were changed every treatment (three times per week).
For the subjects with neuropathic ulcers, healing rate was 70.0% [+ or -] 32.3% in the biphasic group and 42.0% [+ or -] 22.3% in the monophasic group (p<0.01). However, for the subjects with pressure ulcers, no significant difference could be demonstrated between subjects receiving biphasic vs. monophasic current (p>0.05); see Figure 1. For subjects receiving biphasic current, healing rate was significantly greater for those with neuropathic than for those with pressure ulcers (p<0.01); see Figure 1.
Blood Flow during electrical stimulation
People with pressure ulcers: Biphasic vs. Monophasic current outside and at the center of the wound
People with pressure ulcers demonstrated significantly greater blood flow with biphasic current than with monophasic current at the initial test (p<0.001) and week 2 (p<0.001); see Figure 2. Monophasic current produced a significant increase in blood flow during stimulation (p<0.049) from week 1 to week 4; see Figure 2. No significant changes in blood flow at the center of the wound could be demonstrated between the two currents and total blood flow to the area (p>0.05).
People with neuropathic ulcers: Biphasic vs. Monophasic current outside and at the center of the wound
Biphasic current produced a significant increase in blood flow during stimulation from day 1 to week 2 (p<0.014); see Figure 3. Comparing the two currents, people with neuropathic ulcers demonstrated a significant increase in blood flow using biphasic current vs. monophasic current at week 2 (p<0.05); see Figure 3.
Total blood flow at the center of the wound was not significantly different between the two currents (P>0.05).
Resting blood flow between tests-The "carryover effect"
Outside of the wound
The "carryover effect" refers to elevated blood flow from pre-stimulation of the 1st day compared with the pre-stimulation value of the 2nd and/or 4th week. Monophasic and biphasic current demonstrated the "carryover effect" for people with pressure ulcers from the 1st day of pre-stimulation to the 2nd week of pre-stimulation (p<0.049); see Figure 2. Biphasic current resulted in more blood flow at week 2 pre-stimulation vs. monophasic current (p<0.049); see Figure 2. No "carryover effect" could be demonstrated from day 1 to pre-stimulation of week 4 for both currents.
People with neuropathic ulcers also had a "carryover effect" using biphasic and monophasic current. Biphasic current increased blood flow from day 1 pre-stimulation to week 2 (p<0.042) and week 4 (p<0.025); see Figure 3. Monophasic current had a "carryover effect" but only from day 1 pre-stimulation to week 2 of pre-stimulation (p<0.05); see Figure 3. Biphasic current also produced more blood flow compared with monophasic current during day 1 pre-stimulation to week 2 of pre-stimulation (p<0.045); see Figure 3.
Center of the wound
No pre-stimulation difference was found with monophasic or biphasic current at the center of the wound in people with neuropathic and pressure ulcers (p>0.05).
This study compared electrical stimulation with two waveforms to healing rates and blood flow in people with chronic pressure and neuropathic ulcers. The present study is the third to report diagnostic-specific samples of adults with diabetes, electrical stimulation, and healing rates. (21-22) People with neuropathic and pressure ulcers using biphasic electrical stimulation had significantly better healing rates than those receiving monophasic electrical stimulation (P<0.02).
The healing rates from this present study are in agreement with Baker et al (22) who used monophasic current for people with neuropathic ulcers; 45.6% [+ or -] 28% vs. 42% [+ or -] 24% over 4 weeks. A significant improvement was observed when using biphasic electrical stimulation. Our study found a healing rate of 70% [+ or -] 32.3% vs. 16.4% [+ or -] 6.1 in the study of Baker et al (22) over 4 weeks.
Two parameters that were different from the study of Baker et al (22) is pulse duration and ambient temperature. Pulse duration used in Baker study was 100 [micro]s compared with 200 [micro]s in our study. Also, the Baker study did not include information on room temperature. Our study was conducted in a 32[degrees]C room.
Revascularization to increase blood flow is the therapy of choice for people with critical limb ischemia to help heal ischemic ulcers or gangrene. (35-36) Nearly 450 people who had inoperable chronic critical leg ischemia found significantly higher limb salvage after 12 months of spinal cord stimulation (SCS) in a Cochrane review. (37) The Cochrane review used the mean TcP[0.sub.2] results after 12 months and found no significant difference in TcP[0.sub.2] when looking at all the studies. This review did not mention exclusion or inclusion of people with diabetes.
Our study demonstrated a significant increase in blood flow using a laser Doppler flow meter in people with neuropathic wounds. Biphasic electrical stimulation consistently demonstrated more blood flow and significant healing rates outside of the wound. Week 3 to week 4 demonstrated little change in blood flow at pre-stimulation and 30 minutes of stimulation. Also, both monophasic and biphasic current points at week 4 baseline were near or lower than the first day of testing. We believe this was due to the healing of the wounds. Also note that blood flow was not different at the center of the wound between the two currents. The appropriate dose of electrical stimulation and mechanism of delivery that increased blood flow to the outside of the wound appeared to be insufficient to reach the center of the wound. The electrical stimulation appeared to be shunted around the center of the wound based upon the changes in blood flow in the center and the outside of the wound. More research needs to be conducted with stimulation and the center of the wound.
The study of Baker et al (22) did not mention temperature but the treatment was conducted in an inpatient facility. In a cold room, vasoconstriction elicited by sympathetic adrenergic innervation can block skin blood flow from increasing during electrical stimulation (37-40) This situation may occur when a patient sits in a typical cold treatment room. (40) Our study was conducted in a 32[degrees]C room, whereas we can only assume that Baker's study was conducted at typical room temperature. The increase in blood flow using heat vs. ambient temperature may be explained by heat's influence on microcirculation. The vascular endothelial cell lining of blood vessels controls vascular smooth muscle by chemical transmitters. (41) Nitric oxide can enter the smooth muscle layer and cause relaxation and dilation of the blood vessel through the production of guanosine 3',5' monophosphate. (41) Conversely, vasoconstrictive substances such as norepinephrine cause vascular cells to release prostaglandins that increase the permeability of vascular smooth muscle resulting in vasoconstriction. (42-43) A balance between vasoconstriction and vasodilation factors on smooth muscle tone largely determines localized blood flow. This balance is, in part, due to factors released from endothelial cells. (44) People with diabetes have a baseline reduction in nitric oxide synthetase or impairment in nitric oxide synthesis. (45) Heat appears to assist blood flow by decreasing the sympathetic vasoconstrictor tone by altering either nitric oxide production or another vasodilator mediator from the vascular endothelial cells. Details on this topic with people with diabetes, electrical stimulation and a warm room can be found in other studies. (20)
Further studies are needed to measure electrical stimulation dose inside the wound. Electrical stimulation alternating the circuitry and use of more electrodes may provide more stimulation to the target tissue. Measuring the dose of electrical stimulation in the target tissue should be another parameter to help define effective electrical stimulation protocols for wound healing.
When comparing biphasic vs. monophasic current in people with neuropathy, healing rate was greater in the biphasic group (p<0.02). The use of biphasic current electrical stimulation was significantly more effective in healing wounds in people with neuropathic vs. pressure ulcers. Comparing pre-stimulation or the "carryover effect," both currents demonstrated this effect in neuropathic ulcers. Biphasic current had increased blood flow from day 1 pre-stimulation to week 2, and week 4. Future studies may want to observe local heat vs. global heat with electrical stimulation and people with neuropathic wounds along with achieving a better dose of electrical stimulation at the center of the wound.
We wish to thank Renown Wound Center, Reno, NV and their excellent staff for allowing this study to be conducted at their facility. There was no funding source or conflict of interest for this research project.
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Daryl Lawson, PT, DSc. Associate Professor at Elon University. Please send all correspondence to email@example.com
Jerrold Petrofsky, PhD, J.D., Professor at Loma Linda University. Please send all correspondence to firstname.lastname@example.org
People with Neuropathic Ulcers Current Subjects Age Height Type (cm) Biphasic 10 64.7 [+ or -] 13.2 173.5 [+ or -] 8.6 Current Monophasic 10 55.7 [+ or -] 11.5 178.4 [+ or -] 8.6 Current Current Weight Duration Location Type (Kg) of wound (Months) Biphasic 77.7 [+ or -] 11.1 10.6 [+ or -] 8.1 3-left heel, Current 3-right heel, 2-right great toe, I-distal right 2nd toe, 1-distal left 3rd toe Monophasic 90.9 [+ or -] 21.9 10.6 [+ or -] 8.08 3-left heel, Current 3-right heel, 1-left great toe, 2-right great toe, 1-distal left 2nd toe, People with Pressure Ulcers Subjects Age Height (cm) Biphasic 10 55.3 [+ or -] 22.6 168.7 [+ or -] 5.6 Current Monophasic 10 55 [+ or -] 15.1 173 [+ or -]9.2 Current Weight Duration Location (Kg) of wound (Months) Biphasic 73.4 [+ or -] 12.6 12.7 [+ or -] 9.0 2-right greater Current trochanter, 1-left greater trochanter, 3-sacral wounds, 1-right heel wound, 1-left heel wound, 2-buttock wounds Monophasic 80.5 [+ or -] 13.2 14.6 1-right greater Current [+ or -] 10.2 trochanter, 1-left greater trochanter, 3-sacral wounds, 2-right heel wound, 2-left heel wound, 1-buttock wounds
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|Title Annotation:||RESEARCH REPORT|
|Author:||Lawson, Daryl; Petrofsky, Jerrold|
|Publication:||Journal of Acute Care Physical Therapy|
|Date:||Mar 22, 2013|
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