Accelerated
Wound Healing of Pressure Ulcers by
Pulsed High Peak Power by |
MasayoshiItoh, MD, MPH
Associate Professor of Clinical Rehabilitation Medicine New
York University Medical Center Associate Deputy Director of
Department of Rehabilitation Medicine Deputy Director Skilled
Nursing Facility Goldwater Memorial Hospital New York, NY
Jesus S. Montemayor, Jr., MD
Attending Physician Skilled Nursing Facility Department of Rehabilitation
Medicine Goldwater Memorial Hospital New York, NY Etsuko
Malsumoto, RN, MA
Associate Director of Nursing Goldwater Memorial Hospital New
York, NY Alice Eason, MPA, PT
Chief, Physical Therapy Service Department of Rehabilitation
Medicine Goldwater Memorial Hospital New York University Medical
Center New York, NY Mathew H.M. Lee, MD, MPH
FACP Chairman, Professor of Department of Rehabilitation Medicine
(Acting) New York University Medical Center New York, NY
Frank S. Folk, MD
Assistant Professor of Clinical Surgery Health Science Center
Brooklyn Member of Board of Directors Health and Hospitals Corporation
The City of New York New York, NY Acknowledgements
Authors wish to acknowledge invaluable assistance provided by
Mr. Samuel Lehrfeld, Executive Director of Goldwater Memorial
Hospital, and encouragement by Officers of The Health and Hospitals
corporation of the city of New York.
Address all correspondence to Dr. M. Itoh, Skilled Nursing Facility,
Goldwater Memorial Hospital, FD Roosevelt Island, New York,
NY 10044.
This study received no funding from the manufacturers of Diapulse
and none of the authors have financial interest in the product. |
| ABSTRACT |
The purpose of this study was to evaluate the effect of pulsed
high-frequency, high peak power electromagnetic energy (Diapulse)
in the healing of pressure ulcers. Patients with Stage H ulcers
unhealed within three to 12 weeks and those with Stage HI ulcers
unhealed within eight to 168 weeks by conventional methods were
included in the study. When Diapulse was added to conventional
therapy during the nine-month study, all 22 patients healed
as evidenced by photographs and measurements of the ulcers.
Stage H ulcers healed in one to six weeks (mean 2.33) and all
Stage HI ulcers healed in one to 22 weeks (mean £85).
The decreased healing time can provide significant cost savings
and improved patient care.
The pressure ulcer, a pervasive health problem, is one of several
preventable, but sometimes fatal, secondary disabilities. Individual
suffering and financial expense to society are enormous (Itoh
& Lee, 1990; NPUAP, 1989). Pressure ulcers are highly prevalent
among the neurologically impaired, chronically ill, and elderly
(Lee & Itoh, 1988; Allman, 1989a, 1989b, 1986). The natural
history, particularly causative factors, is well documented,
and pressure ulcer epidemiological considerations have been
described (Daniel, Priest, & Wheatley, 1981; Kosiak, 1959;
Witkowski & Parish, 1982). |
| ACCELERATED WOUND HEALING |
In acute care hospitals, the prevalence of pressure ulcers
ranges between 3% and 14%, in long-term care settings 15% and
25% (Reed, 1981).
Development of pressure ulcers in a healthcare facility is often
difficult to avoid. A shortage of nursing personnel may become
a contributory factor for ulcer development if there is not
enough time to turn patients. Prognosis of a pressure ulcer
is extremely difficult because of many factors, which contribute
to formation of an ulcer, such as pressure, nutritional status,
and severity of health problems.
Under the most ideal situation, Stage II ulcers should heal
within one month, while Stage III ulcers may require three months
or longer, depending on size (Allman, 1989). When the ideal
situation is not attainable, the actual time required for healing
an ulcer may double or triple. A chronic pressure ulcer with
duration of one year or longer is most unlikely to heal, or
healing would require an inordinate period of time.
When a pressure ulcer develops in a given area and remains untreated
without eliminating or minimizing the causative factors, the
ulcer continues to progress. The progression may be expressed
by size and depth and is commonly classified in four stages
(NPUAP, 1989). It is universally recognized that the higher
the stage, the longer the period required for healing. Frequently,
even with meticulous skin treatment and other physical care
provided by nursing staff, the ulcer persists and progresses.
Conventional treatment with topical medication, vitamin and
dietary therapy, specialized beds or support systems, plus modalities
such as ultraviolet or iontophoresis have been utilized for
treatment of Stage IL to IV ulcers with limited success (Allman,
1989a, 1986). The ulcer may eventually heal, providing the causative
elements are eliminated and no further complications develop.
Slow-healing ulcers require prolonged hospital stay, enormous
costs in personnel and materials, and the patient may develop
other secondary disabilities, which further delay rehabilitation.
The average cost of pressure ulcer treatment is estimated to
be approximately $2,000 to $30,000 (NPUAP, 1989) and is reported
to range as high as $86,000 per patient (Allman et aL, 1986). |
| HEALING METHODS |
The healing process of pressure ulcers is similar to healing
of other wounds. There are many studies available that describe
wound-healing processes (Brown, Nanney, Griffen, et al., 1989;
Eaglestein, & Mertz, 1981; Knighton, Ciresi, Fiegel, Austin,
& Butler, 1986)
The use of pulsed high-frequency high peak power electromagnetic
energy (Diapulse) has recently been described by the Food and
Drug Administration as a segment of "Emerging Electromagnetic
Medicine" (O’Connor, 1990). Experimental and clinical
applications of this energy are reported in the literature as
providing a safe and effective method of alding soft tissue
healing (Goldin, Broadbent, Nancarrow, & Marshall, 1981;
Ross, 1990), reduction of edema (Rhodes, 1981), absorption of
hematoma (Fenn, 1969) reduction of inflammation (Wilson, 1972),
nerve (Raji & Bowden, 1983) and spinal cord regeneration
(Kiwerski, Chrostowski, & Weiss, 1980), and peripheral vasculature
(Erdman, 1960).
Although the mechanism of action is not well understood, studies
have revealed that Diapulse produces certain biological effect,
which enhance wound healing. Increased blood flow without hyperpyrexia
or tissue damage has been observed by application of Diapulse
(Erdman, 1960). With the increase of blood flow there is an
increase of oxygen to the previously deprived regions.
Cameron (1961) conducted a histological study on the effect
of pulsed high-frequency radio waves (Diapulse) on accelerating
wound healing. Results on acute wounds demonstrated a stimulation
of collagen formation, WBC infiltration phagocytosis, histiocytic
activity, fat activity, and hematoma canalization. Hymes (1986)
also demonstrated an increase in plasma fibronectin concentration
to a wound site.
An enzyme study on burn wounds (Ionescu, 1984) demonstrated
that when compared to normal skin, the activities of proteins,
LDH, and alkaline phosphatase are considerably and significantly
increased after Diapulse therapy. The author noted that the
earlier Diapulse is applied to injured tissue, the more rapidly
are normal enzymatic activities restored.
Additional laboratory studies (Young, 1984) demonstrate that
Diapulse applied to spinal cords shortly after contusion reduces
calcium accumulation in the cord adjacent to the injury site.
This change in calcium is associated with better recovery of
motor and sensory function in severe spinal injury.
Duma-Drzewinska and Buczynski (1978) reported that Diapulse
was a positive influence in treatment of superficial and deep
pressure ulcers, which had failed to heal when treated with
conventional therapies. |
| MATERIAL AND METHODS |
Based on the literature, this clinical trial was designed
to assess the effect of Diapulse treatment on healing of Stage
II and Stage III pressure ulcers which were demonstrably slow
to heal or failed to heal with conventional treatment.
Diapulse technology produces pulsed high-frequency high peak
power electromagnetic energy, and operates on an assigned Federal
Communication Commission medical frequency of 27.12 MHz. The
energy is delivered in 65 microsecond bursts at six settings
of 80 to 600 pulses per second with a wattage range from 293
to 975 peak watts in six steps. Energy is induced through a
9-inch diameter drum-shaped treatment head, placed in contact
with the area to be treated. Treatment is non-invasive and can
be applied through clothing and surgical dressings.
Seven patients (four male, three female) ranging in age from
52 to 86 years (mean 70.1) with nine Stage II pressure ulcers,
and 13 patients (five male, eight female) ranging in age from
49 to 93 (mean 69.7) with 13 Stage III pressure ulcers, were
studied over a nine-month period. AM were institutionalized
patients.
Ulcers selected for the study had received conventional treatment
for eight or more weeks, except for three. The three exceptions
were Stage II ulcers which showed a duration of three weeks
but their deterioration was so rapid they may have progressed
to Stage III and possibly to Stage IV if eight weeks had passed
before including them in the study.
All patients had routine blood work to determine RBC, WBC, hematocrit,
and hemoglobin, electrolyte levels, and nutritional status within
normal limits. Excluded from the study were patients with cardiac
pacemakers, malignancy, or metallic implants in the area of
the ulcer.
All patients’ demographic data and past histories of pressure
ulcers were extracted from their medical records. Time elapsed
between the earliest documented presence of the ulcer and the
date Diapulse treatment commenced was calculated in weeks. The
duration of the ulcer for each patient was used as a control.
The ulcers were located on the sacrum (7), buttock (4), heel
(5), leg (2), foot (2), right malleolus (1) and knee (1). The
primary diagnoses among the patients were cerebrovascular accident
(3 1.8%) with three Stage II and four Stage III pressure ulcers;
multiple sclerosis (22.7%) with three Stage II and two Stage
III ulcers; organic brain syndrome (18.2%) with two Stage II
and two Stage III ulcers; spinal cord tumor (9.1%) two Stage
III ulcers; spinal cord injury (4.55%) one Stage III; spinal
stenosis (4.55%) one Stage III. (See Table I) Table
1
Primary Diagnosis And Stage Of Pressure Ulcer
| Primary Diagnosis |
Stage 2 (S-2) |
Stage 3 (S-3) |
Total |
% |
CVS S-2: FC, FC, HE
S-3: MH, HA, LG FC |
3 |
4 |
7 |
31.8 |
MS S-2: PC PC FA
S-3: SC FA |
3 |
2 |
5 |
22.7 |
Organic Brain Syn. S-2:
JS RC
S-3: FS ER |
2 |
2 |
4 |
18.2 |
Spinal Cord Tumor S-2:
S-3: PW DS |
0 |
2 |
2 |
9.1 |
Diabetes Mellitus S-2:
S-3: WA |
1 |
1 |
2 |
9.1 |
Spinal Cord Injury S-2:WA
S-3: IM |
0 |
1 |
1 |
4.55 |
Spinal Stenosis S-2
S-3: WC |
0 |
1 |
1 |
4.55 |
| Total |
9 |
13 |
22 |
100.00 |
Conventional treatment prescribed prior to commencement of
Diapulse was continued without any modification. The conventional
methods included cleansing with H202, sterile normal saline,
or povidone iodine. Dressings included Bacitracin ointment,
povidone iodine (wet/dry), acetic acid (wet/dry), Vaseline
gel, Silvadene, or H202 dressing (wet/dry). Granulex spray
was administered to two Stage III ulcers. Water mattresses
were provided for one Stage II and three Stage III patients.
Diapulse was applied to each ulcer, directly through dressings,
at 600 Pulse Frequency and 6 Peak Power for a period of 30
minutes twice daily at approximately eight-hour intervals.
Although the application of Diapulse therapy was the responsibility
of personnel on the unit where the patient was located, one
technician with special training was responsible to check
that the personnel administering the treatment were trained
in the use of Diapulse and that treatments were carried out
correctly on all shifts.
To document and analyze the progress of wound healing, serial
visual evaluations (including measurement of the ulcer) and
35mm color photographic observations were made. A professional
rehabilitation nurse specialist and physician also conducted
assessments at set weekly intervals. Photographs of each site
were made with a centimeter scale in view with the camera
kept at a fixed focal distance.
Results
Tables II and III show healed Stage II and III ulcers after
Diapulse was added to conventional treatment. Stage II ulcers
ranged in size from 1 cm2 to 15 cm2 (mean 5.55 cm2) and Stage
III from 0.09 cm2 to 40 cm2 (mean 8.77 cm2). The depths of
Stage III ulcers were 0.5 cm to 1.0 cm (except one which was
3 cm). The duration of Stage II pressure ulcers prior to adding
Diapulse ranged from three to 12 weeks (mean 8.2) and Stage
III ulcers, eight to 168 weeks (mean 34.6). The duration of
combined Diapulse and conventional treatment to complete healing
(treatment duration) was one to six weeks (mean 2.3) for Stage
II ulcers and one to 22 weeks (mean 8.85) for Stage III ulcers.
Table 2
Healed Stage 2 Pressure Ulcer: Diapulse And Conventional Treatment
Diapulse &
Conventional Treatment Conventional
Treatment
| Primary Diagnosis |
M |
F |
Age |
Ulcer Location |
Duration
(Weeks) |
Ulcer Size
(cm2) |
Duration
(Weeks) |
Status |
| AW |
1 |
0 |
79 |
Sacrum |
3 |
3.00 |
4 |
Healed |
| PC |
1 |
0 |
56 |
Sacrum |
3 |
2.25 |
1 |
Healed |
| PC |
1 |
0 |
56 |
Buttock |
3 |
15 |
3 |
Healed |
| CA |
0 |
1 |
52 |
Buttock |
8 |
1 |
1 |
Healed |
| JS |
0 |
1 |
77 |
Knee |
12 |
1.00 |
1 |
Healed |
| FC |
1 |
0 |
86 |
Rt. Mal. |
12 |
7.50 |
6 |
Healed |
| FC |
1 |
0 |
86 |
Foot |
12 |
7.50 |
3 |
Healed |
| HE |
1 |
0 |
60 |
Leg |
12 |
6.75 |
1 |
Healed |
| RC |
0 |
1 |
81 |
Heel |
9 |
6.00 |
1 |
Healed |
| Total |
6 |
3 |
|
|
74 |
|
21 |
|
| Mean |
|
|
70.33 |
|
8.22 |
5.56 |
2.33 |
|
| SD |
|
|
12.6 |
|
3.94 |
4.18 |
1.70 |
|
Table 3
Healed Stage 3 Pressure Ulcer: Diapulse And Conventional Treatment
Diapulse & Conventional Treatment
Conventional Treatment
| Primary Diagnosis |
M |
F |
Age |
Ulcer Location |
Duration
(Weeks) |
Ulcer Size
(cm2) |
Duration
(Weeks) |
Status |
| FS |
0 |
1 |
82 |
Sacrum |
52 |
.15 |
1 |
Healed |
| GL |
0 |
1 |
49 |
Sacrum |
168 |
1.0 |
7 |
Healed |
| DS |
0 |
1 |
56 |
Sacrum |
16 |
.09 |
6 |
Healed |
| IM |
1 |
0 |
57 |
Sacrum |
10 |
4.50 |
6 |
Healed |
| MH |
0 |
1 |
61 |
Sacrum |
52 |
.25 |
22 |
Healed |
| PM |
0 |
1 |
93 |
Heel |
14 |
1.00 |
3 |
Healed |
| AW |
0 |
1 |
79 |
Heel |
24 |
17.5 |
8 |
Healed |
| FC |
0 |
1 |
79 |
Heel |
34 |
28.00 |
13 |
Healed |
| ER |
0 |
1 |
91 |
Heel |
12 |
5.60 |
6 |
Healed |
| WC |
1 |
0 |
65 |
Heel |
44 |
40.00 |
21 |
Healed |
| SC |
1 |
0 |
70 |
Leg |
8 |
1.00 |
7 |
Healed |
| HA |
1 |
0 |
72 |
Foot |
8 |
9.00 |
10 |
Healed |
| CA |
0 |
1 |
52 |
Buttock |
8 |
6.00 |
5 |
Healed |
| Total |
5 |
8 |
|
|
|
|
115 |
|
| Mean |
|
|
69.7 |
|
|
|
8.85 |
|
| SD |
|
|
14.0 |
|
|
|
6.09 |
|
Clinical observation revealed that within 24 to 48 hours of
initiating Diapulse treatment, most Stage II ulcers showed
an appearance of drying with start of scab formation and proceeded
to heal. At 24 to 48 hours the granulation color of Stage
III ulcers became bright red. Within seven to 10 days, pale
colored epithelialization became visible around the edges
and exudate began to decrease.
Purulent exudate was eliminated without any systemic or local
use of antibiotics.
In one Stage III ulcer (Table III, Case WC), a necrotic area
of dermis with an approximate size of 2 x 3 cm was observed
at the center of a 4 x 10 cm ulcer on the leg before start
of Diapulse treatment (Figure I). A conventional treatment
approach for this necrotic dermis is surgical debridement.
After one week of Diapulse treatment, the necrotic tissue
was eliminated (Figure II). The ulcer subsequently healed
(Figure III).
After beneficial results of Diapulse treatment were demonstrated,
one additional patient was added to the study. The patient’s
Stage III ulcer had failed to heal with conventional treatment
over a period of 168 weeks. After seven weeks of combined
Diapulse and conventional treatment, the ulcer completely
healed.
The epidermis of a newly healed pressure ulcer after Diapulse
treatment is fragile, and friction between the new epidermis
and protective dressing can cause excoriation. An additional
seven to 10 days of Diapulse treatment to the area was effective
in preventing such occurrence.
Figure 1
WC 12790 B-11 (leg) 5/31/89
Date 5/31/89 Prior to commencement
of Diapulse
treatment necrotic dermis observed in pressure ulcer.
Figure 2
WC 12790 B-11 (leg) 6/07/89

Date: 6/7/99 First week assessment.
Necrotic tissue no longer in evidence.
Figure 3
WC 12790 B-11 (leg) 11/01/89
Date: 11/1/89 Pressure ulcer healed. |
| DISCUSSION |
| Patient selection for the study was limited to chronic ulcers
without any sign of healing, or ulcers of short duration that
were deteriorating rapidly with conventional treatment. The
conventional treatment in use was continued during the study
and, to limit variables, the only new element introduced to
the treatment regimen was Diapulse. This method of evaluation
demonstrated that it was the addition of Diapulse that aided
the healing of the pressure ulcers. A distinct advantage of
the Diapulse treatment was the simplicity of application. Once
the patient is comfortable and the Diapulse treatment head is
placed over the pressure ulcer, it is necessary only to ascertain
that Diapulse head and patient remain in position. |
| COST FACTOR |
Cost of pressure ulcer treatment is a significant factor contributing
to the financial burden of patients, families, institutions,
and healthcare payment systems. Costs include personnel and
support services; materials such as pressure relieving devices;
pharmaceutical and nonpharmaceutical supplies; laboratory tests;
and physical therapy.
At this institution in 1990, conventional treatment cost of
a Stage III ulcer in the buttock or sacral area (including the
costs of personnel and dressing material) was approximately
$8.94 to $10.93 per treatment depending upon the personnel involved.
With change of dressing performed three times per day, the cost
of ulcer treatment varies between $187.74 and $229.53 per week.
One 30-minute Diapulse treatment administered twice daily by
a medical surgical technician costs $7.23 (including the use
of the Diapulse unit) with a weekly cost of $101.22.
Nine Stage II pressure ulcers received conventional treatment
for a mean average of 8.22 weeks. The cost per ulcer of conventional
treatment was $ 229.53 per week, with a total cost of $1,886.74
per ulcer. None of these ulcers demonstrated evidence of healing
during the entire course of treatment. The ulcers were then
treated with a combination of Diapulse and conventional treatment
for a mean average of 2.33 weeks. The mean cost of treatment
per ulcer was $331.03 per week, with a total cost of $771.30
per ulcer. All Stage II ulcers completely healed.
Thirteen Stage III pressure ulcers received conventional treatment
for a mean average of 34.62 weeks. The mean cost of conventional
treatment per ulcer was $229.53 per week with a total cost of
$7,946.33. These ulcers demonstrated no evidence of healing
during the entire course of treatment.
The ulcers were then treated with Diapulse and conventional
treatment for a mean average of 8.85 weeks. The cost of treatment
per ulcer was $331.03 per week with a total cost of $2,929.62
per ulcer. All Stage III ulcers completely healed.
A cost differential between conventional treatment and Diapulse
and conventional treatment of Stage II ulcers, showed a mean
average of $1,115.44 per ulcer. Treatment of the nine ulcers
with combination therapy produced a total savings of $10,038.96.
The same comparison was made for the Stage III ulcers. The cost
differential between conventional treatment and Diapulse and
conventional treatment of Stage III ulcers showed a mean average
of $5,016.71 per ulcer. Treatment of the 13 ulcers with combination
therapy indicated a total savings of $65,217.23. |
| SUMMARY |
After a thorough review of the literature, we found that under
current hospital conditions there was no evidence of complete
healing of Stage II ulcers in a mean average of 2.33 weeks and
Stage III ulcers in a mean average of 8.85 weeks.
Based on historical and clinical experience, any improvement
in rate and degree of healing of the ulcer was attributable
to Diapulse technology. More importantly, all 22-pressure ulcers
in this study healed after Diapulse had been added to the conventional
regimen of treatment. |
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