Contemporary Surgery |
| July 1995 Vol. 47, No. 1 |
The Application of Diapulse® in the Treatment of Decubitus
Ulcers: Case Reports
Shirley Tung, M.D.
Albert Khaski, M.D.
Evelyn Milano, R.N.
Charlotte Kay, R.N.
Dr. Shirley Tung is director of surgery, Gouverneur Clinics.
Dr. Albert Khaski is the medical director, Evelyn Milano is
an associate executive dir rector, and Charlotte Kay is assistant
director of nursing, Gouverneur Hospital Skilled Nursing Facility,
New York, New York. |
| ABSTRACT |
| Surgical debridement of necrotic tissue is
only the first step in the long process of reversing tissue
injury or ischemia and providing an environment for healing
of decubitus ulcers. When an elderly patient who suffers from
systemic problems has a deep decubitus ulcer in which there
is significant loss of tissue, healing can take a long time,
and transfer to a chronic care facility may be required to provide
extended treatment. A recalcitrant wound on an extremity presents
a threat of limb loss if the prerequisites for healing are not
present; no matter how clean a wound is kept, healing may not
occur. Four cases are reported in which considerable tissue
loss occurred on a compromised extremity that did not respond
to conventional wound treatment. Total healing allowing limb
salvage was achieved with the use of Diapulse, a new technology
that can be a key element in complete healing of stage IV ulcers.
This report demonstrates that rapid healing of decubitus ulcers
can occur in a chronic care setting when special attention is
directed to all details required for wound healing. [Contemporary.
Surgery 47(1):27-32, 1995.] |
| INTRODUCTION |
The incidence of decubitus ulcers in patients
in acute care facilities is 9.2% and the incidence ranges from
2.4-28% in long-term chronic care and nursing facilities.©ˆ
Shear and pressure cause skin changes, particularly in immobilized
elderly patients,©˜ and a stage II ulcer can rapidly
progress to a stage 111 or IV. When additional detrimental factors
such as diabetes mellitus, peripheral vascular disease, anemia,
uremia, hypoproteinemia, hypoxia, etc. are involved, healing
frequently is impossible and there is a risk of limb loss."3,4
A serious attempt to achieve complete wound healing has been
a focus of the surgical/nursing team at Gouverneur Hospital
Skilled Nursing Facility. However, in spite of surgical debridements
and the use of specialty beds, ointments, dressings, alginates,
etc., in many cases stage IV ulcers did not heal.
The use of pulsed high frequency radiowaves in the form of Peak
power electromagnetic energy delivered by Diapulse therapy is
a new technology used to promote and accelerate the healing
of decubitus ulcers. The use of electricity 10 accelerate healing
was first hypothesized in 1799.5 However the application of
this concept was hindered for centuries by the lack of a safe
modality to deliver energy. In 1934, a diathermy apparatus was
developed that produced a field of ultra short radio waves using
the body as part of a condenser system rather than as a resistor.6
By 1940, this device was modality to present a pulsed short
wave field using high potentials with adequate cool ling off
time between pulses, eliminating any significant temperature
elevation.
The Diapulse unit operates at 27.l2 MHz (11-meter band) with
a repetition rate of 80-60 pulses per second, a pulse width
of 65 microseconds, a power range per pulse between 298 and
975 watts, and a duty cycle ranging between 0.5-8.9%7
Basic research conducted at the Mayo Clinic on the mechanisms
of action indicates that the high frequency oscillations induce
alignment of the particulate matter in suspension in a "pearl-chain
formation."8 Controlled animal studies revealed accelerated
wound healing in the Diapulse treated group, with evidence of
white blood cell infiltration, phagocytosis, histiocytic activity,
fat, activity, hernatoma canalization, transverse alignment,
and collagen formation.9-11 Additional animal studies using
Wistar rats showed faster regeneration of transected nerves
in the treated group of matched pairs, as indicated by evidence
from histologic and nerve conduction studies.12, 13 A test of
tensile strength with crossover showed greater strength in animals
treated with Diapulse.14
Clinical research on a group of normal young adults showed noticeable
volumetric changes indicative of increased blood flow in all
20 cases when volumetric plethysmography was measured over the
toes.15 A study of intermittent claudication provided evidence
of improved blood flow, and wound-healing improvement was noted
with the use of Diapulse in plastic and reconstructive surgery.17
In addition, the growth of Fibronectin in wound healing was
stimulated in a control study.18
The efficacy of this technology was demonstrated in a clinical
trial performed in a rehabilitation department in which Diapulse
treatments were applied for 20 minutes every 24 hours in 27
spinal cord injury patients with pressure uIcers.19 Of 12 superficial
ulcers, 11 healed completely and one showed considerable progress.
Four of 15 deep ulcers healed completely, six showed considerable
progress, and five showed moderate progress. No case demonstrated
lack of progress and no detrimental effects were noted.
A controlled investigation demonstrated the value of the adjunctive
use of Diapulse to achieve successful healing of stage II and
III decubitus ulcers.20 A double-blind study conducted at a
Veterans hospital revealed that complete healing of pressure
ulcers occurred three times faster with the use of Diapulse,
thereby reducing the length of hospital stay.2’
In another clinical trial of the effect of Diapulse on pressure
sores in neurologically impaired patients, treatments were administered
twice daily, eight hours apart, for 30 minutes each.22 In a
nine month period, nine stage II ulcers that had not healed
with conventional methods in the prior three to 12 weeks healed
in one to six weeks with the adjunctive use of Diapulse. Thirteen
stage III ulcers that previously had remained unhealed for eight
to 168 weeks were completely healed in one to 22 weeks with
the addition of Diapulse to the treatment regimen.
Since 1991, Diapulse has been used at Gouverneur Hospital on
many decubitus ulcers, including stage IV. The patient population
is elderly and has a wide range of chronic medical and rehabilitative
problems. Sixty-five percent of the patients were more than
80 years of age, and 35% were diabetic. Complete healing of
29 long-term extremity and trunk stage IV ulcers was attained.
Treatments were administered three times a day for 30 minutes
for stage III and TV ulcers; superficial stage II ulcers received
treatments twice daily. Conventional modes of supportive therapy
were continued, i.e., wound dressings, debridement as required,
antibiotics when appropriate, and tube feedings as necessary. |
| CASE REPORTS |
Case 1 (Fig. 1):
Fig. 1A (Case 1) View of large necrotic heel ulcer two weeks
after start of Diapulse in diabetic patient on dialysis. Note
eschar.
A 66-year-old Hispanic male diabetic with renal failure who
was on dialysis was admitted with necrotic black bilateral heel
decubitus ulcers. His medical history was significant for coronary
artery bypass graft myocardial infarction, congestive heart
failure, and multiple AV shunt infections. He was chronically
anemic with an average hematocrit of 31. BUN/creatinine averaged
43/2.4, and he was hypoalbuninemic (total protein 6.8, albumin
2.9).
Fig. 1B (Case 1) Right heel ulcer four weeks after
start of Diapulse & multiple debridements.
The patient was placed on an air mattress. At the start of Diapulse
treatments, the ulcer on the left measured 1.5x1x0.4cm and the
larger ulcer on the right heel measured 9x3x [?] cm. The necrotic
process was controlled with debridements and Betadine dressings.
Once the ulcers were clean, normal saline dressings were applied.
Fig. 1D (Case 1) right heel ulcer four weeks after start of
Diapulse & multiple debridements.
During the course of treatment of the ulcers, the patient was
transferred in and out of an acute care facility for dialysis
and the management of shunt-related problems, including infection.
Despite the lack of continuity in treatment, the ulcers became
less necrotic. Even though the patient had diabetes and renal
failure, which are both known to retard healing, the ulcer on
the left heel healed without incident in nine weeks and healing
of the larger ulcer on the right heel occurred in 30 weeks.
The patient became fully ambulatory after heating of the ulcers.
Fig. 1C (Case1) Completely healed right
heel six months
after use of Diapulse
Fig. 1E (Case 1) Left heel nearly healed 22 days later:
continuing with Diapulse
Case 2 (Fig. 2):
An 87-year-old black male who was not diabetic was admitted
with a large ulcer on his right heel measuring 12x7x?cm. The
patient’s medical history included hypertension, CVA,
renal insufficiency, anemia, and dementia. His hematocrit was
27, BUN/creatinine was 29/1.5, total protein/albumin was 7/2.7.
Fig. 2A (Case 2) Large necrotic
right heel ulcer
three weeks after start of Diapulse. Note eschar.
The patient was placed on a DFS bed. The necrotic black eschar
on the right heel underwent multiple debridements, and Betadine
dressings were applied regularly. Diapulse treatments were begun
two weeks following admission. However, the necrotic process
had extended deep into the depths of the soft tissues and into
the bone. The patient was transferred to an acute care facility
for intravenous antibiotics and bony debridement.
Fig. 2B (Case 2) Right heel ulcer almost
six months after start of Diapulse and debridements. The bone
is still visible. The patient was treated for osteomyelitis.
Upon return after hospitalization for treatment of the osteomyelitis,
the patient was continued on oral ciprofloxacin. At the time
of readmission, the ulcer measured 20x7x6.5 cm. Diapulse treatments
and use of a DFS bed were re-instituted. Dressings were changed
from normal saline to silver sulfadiazine over the course of
the next few months, during which debridements continued, including
removal of bony sequestrum
Fig. 2C (Case 2) Completely healed right
heel ulcer
with no evidence of osteomyelitis four months later.
Following aggressive treatment including Diapulse therapy, antibiotics,
and multiple debridements, healing of this huge ulcer was achieved
in 43 weeks, avoiding amputation.
Case 3:
A blister developed on the heel of an 86-year-old Caucasian
male diabetic while he was at Gouverneur SNE Despite local wound
dressings, cellulitis of the foot quickly developed, and oral
antibiotics and debridement were required. The stage II ulcer
rapidly progressed and deepened, causing additional loss of
viable heel tissue. Despite the use of wound dressings and an
air mattress the wound reached stage IV within six weeks.
The patient had additional negative health factors including
a prior history of chronic alcohol abuse, arteriosclerosis,
anemia (HCT 28), azotemia (BUN 32), and hypoalbuminemia (total
protein 6.5, albumin 2.8).
When Diapulse treatments were instituted, the heel ulcer measured
3.5x2.3x6 cm. Complete healing was achieved in 25 weeks with
adjunctive Diapulse therapy and the continuation of conventional
treatment methods including Betadine dressings, interval debridements,
and use of an air mattress.
Case 4 (Fig. 3):
A 94-year-old Asian female was readmitted to Gouverneur SNF
with stage II skin changes on the lateral aspect of the right
foot.
Fig. 3A (Case 4) Multiple necrotic right
foot ulcers
six months after start of Diapulse and debridements.
The skin changes progressed during the next
seven weeks to stage IV with conventional treatment without
Diapulse.
The patient had a history of peripheral vascular disease and
had undergone a left above-knee amputation. She had experienced
a CVA, ischemic bowel syndrome, cardiac arrhythmias, and herpes
simplex. Other previous surgical procedures included open reduction
and internal fixation in the right hip and a sacral flap for
the treatment of a decubitus ulcer. Her medications included
digoxin, furosemide, diltiazem hydrochloride, and isosorbide.
The hematocrit was 39, BUN/creatinine 2410.8, total protein/albumin
6.3/2.9.
Fig. 3B (Case 4) Completely healed right
foot ulcer.
Note patient had previous amputation of left leg.
The patient had a thin, frail appearance and a stump from the
left above-knee amputation. Three black, necrotic ulcers involved
the entire lateral aspect of the right foot and the right fourth
webspace. Despite debridements and wound dressings, the ulcers
had a pale, lifeless appearance and the fascia remained exposed
for seven weeks. After Diapulse treatment was instituted, the
appearance of the ulcer improved, becoming redder and more hyperemic.
The three ulcers healed completely after six, 15, and 32 weeks
of Diapulse treatment, respectively, and amputation was averted. |
| DISCUSSION |
| The four case histories presented provide
additional evidence of the safety and efficacy of Diapulse therapy
for the treatment of decubitus ulcers. Despite the depth, size,
and extent of necrosis found in stage IV ulcers, and regardless
of the presence of cellulitis, osteomyelitis, diabetes mellitus,
renal failure, or peripheral vascular disease, complete healing
of an extremity ulcer can be achieved, resulting in limb salvage.4
The requirements for success include meticulous debridements,
appropriate antibiotic intervention, adequate nursing care,
proper nutrition, and stimulation of tissues with Diapulse therapy. |
| CONCLUSION |
Diapulse therapy, which is FDA approved,
has steadily gained acceptance as a means of stimulating wound
healing, and no detrimental side effects have been noted. It
is theorized that Diapulse may function by promoting blood flow,
resulting in a concomitant increase in tissue oxygenization,
thereby creating a milieu suitable for the growth of granulation
tissues.
The Diapulse equipment can be used without an attendant for
the majority of patients. No electrodes or accessories are required,
and the energy penetrates surgical dressings, thereby further
reducing nursing time.
The economic impact of the healing of decubitus ulcers has been
documented, and the costs involved with amputation are well-known.20-23
The surgical-nursing staff at our institution has found that
Diapulse therapy is an effective instrument for providing improved
patient care, result wig in reduced expenses. |
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This study received no funding from the manufacturer of
Diapulse and none of the authors has financial interest in the
product.
The equipment is available only from Diapulse® Corporation
of America, 321 East Shore Road, Great Neck, NY 11023.
Copyright, Bobit Publishing, 1995
Reprinted with permission from Contemporary Surgery, Volume
47, #1 July 1995 |
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