Group Title: Cases Journal 2010, 3:54
Title: Healing enhancement of chronic venous stasis ulcers utilizing H-WAVE® device therapy: a case series
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Title: Healing enhancement of chronic venous stasis ulcers utilizing H-WAVE® device therapy: a case series
Series Title: Cases Journal 2010, 3:54
Physical Description: Archival
Creator: Blum K
Chen ALH
Chen TJH
Downs BW
Braverman ER
Kerner M
Savarimuthu S
Bajaj A
Madigan M
Blum SH
Reinl G
Giordano J
DiNubile N
Publication Date: 40219
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Volume ID: VID00001
Source Institution: University of Florida
Holding Location: University of Florida
Rights Management: Open Access: http://www.biomedcentral.com/info/about/openaccess/

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Blum et al. Cases Journal 2010, 3:54
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CASES
JOURNAL


Healing enhancement of chronic venous stasis

ulcers utilizing H-WAVE device therapy:

a case series

Kenneth Blum1,4,5,6,8*, Amanda LH Chen2, Thomas JH Chen3, B William Downs4, Eric R Braverman45,
Mallory Kerner5, Stella Savarimuthu5, Anish Bajaj5, Margaret Madigan6, Seth H Blum6, Gary Reinl7, John Giordano8,
Nicholas DiNubile9


Abstract
Introduction: Approximately 15% (more than 2 million individuals, based on these estimates) of all people with
diabetes will develop a lower-extremity ulcer during the course of the disease. Ultimately, between 14% and 20%
of patients with lower-extremity diabetic ulcers will require amputation of the affected limb. Analysis of the 1995
Medicare claims revealed that lower-extremity ulcer care accounted for $1.45 billion in Medicare costs. Therapies
that promote rapid and complete healing and reduce the need for expensive surgical procedures would impact
these costs substantially. One such example is the electrotherapeutic modality utilizing the H-Wave" device therapy
and program.
It has been recently shown in acute animal experiments that the H-Wave" device stimulation induces a nitric
oxide-dependent increase in microcirculation of the rat Cremaster skeletal muscle. Moreover, chronic H-wave"
device stimulation of rat hind limbs not only increases blood flow but induces measured angiogenesis. Coupling
these findings strongly suggests that H-Wave" device stimulation promotes rapid and complete healing without
need of expensive surgical procedures.
Case presentation: We decided to do a preliminary evaluation of the H-Wave" device therapy and program in
three seriously afflicted diabetic patients. Patient 1 had chronic venous stasis for 6 years. Patient 2 had chronic
recurrent leg ulcerations. Patient 3 had a chronic venous stasis ulcer for 2 years. All were dispensed a home
H-Wave" unit. Patient 1 had no other treatment, patient 2 had H-Wave" therapy along with traditional compressive
therapy, and patient 3 had no other therapy.
For patient 1, following treatment the ulcer completely healed with the H-Wave" device and program after 3
months. For patient 2, by one month complete ulcer closure occurred. Patient 3 had a completely healed ulcer
after 9 months.
Conclusions: While most diabetic ulcers can be treated successfully on an outpatient basis, a significant proportion
will persist and become infected. Based on this preliminary case series investigation we found that three patients
prescribed H-Wave" home treatment demonstrate accelerated healing with excellent results. While these results are
encouraging, additional large scale investigation is warranted before any interpretation is given to these interesting
outcomes.


* Correspondence' Drd2gene@aol com
'Department of Psychiatry, University of Florida College of Medicine,
Gainesville, FI, USA


0 BioMed Central


2010 Blum et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commono
Attribution Licene (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.






Blum et al. Cases Journal 2010, 3:54
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Introduction
The worldwide increase in prevalence of type 2 diabetes
has resulted in a parallel increase in diabetic foot ulcers,
which is a pervasive and significant problem associated
with this disease [1]. Currently, an estimated 10.3 million
people have been diagnosed with diabetes, while an addi-
tional estimated 5.4 million people with diabetes remain
undiagnosed, representing a six-fold increase in the inci-
dence of diabetes over the past four decades [2]. Approxi-
mately 15% (more than 2 million individuals, based on
these estimates) of all people with diabetes will develop a
lower-extremity ulcer during the course of the disease
[3]. While most of these ulcers can be treated successfully
on an outpatient basis, some will persist and become
infected. Ultimately, between 14% and 20% of patients
with lower-extremity diabetic ulcers will require amputa-
tion of the affected limb [4]. Diabetic foot ulcers can
result in staggering financial burdens for both the health-
care system and the patient. For example, analysis of the
1995 Medicare claims revealed that lower-extremity ulcer
care accounted for $1.45 billion in Medicare costs and
contributed substantially to the high cost of care for dia-
betics, compared with Medicare costs for the general
population [5]. A search in PUBMED revealed that there
has not been an update published on the actual cost of
Medicare for diabetic ulcers, however the cost as stated
earlier they have been increasing at the rate of six-fold
over the last four decades [6]. While there are other con-
ditions that result in chronic venous stasis ulcers such as
vein striping failed surgery, diabetes is a major etiology of
this condition. Therapies that promote rapid and com-
plete healing and reduce the need for expensive surgical
procedures would impact these costs substantially.
It is important to note that while the etiology of dia-
betic foot ulcers is the impairment of microcirculation
and autonomic dysfunction, the causes of chronic
venous insufficiency are multiple. One of the possible
causes of chronic venous insufficiency is extraluminal
lipoma with common femoral vein obstruction. However
it is also of note that the etiology may be best explained
by the well-known valve cusp hypothesis. In this sce-
nario firstly, should the foregoing events not proceed to
frank thrombogenesis, the valves may nevertheless be
chronically injured and become incompetent. Serial
incompetence in lower limb valves may then generate
"passive" venous hypertension. Secondly, should ostial
valve thrombosis obstruct venous return from muscles
via tributaries draining into the femoral vein, "active"
venous hypertension may supervene. Muscle contraction
would force the blood in the vessels behind the blocked
ostial valves to re-route. Passive or active venous hyper-
tension opposes return flow, leading to luminal hypoxe-
mia and vein wall distension, which in turn may impair


vasa venarum perfusion; the resulting mural endothelial
hypoxia would lead to leukocyte invasion of the wall
and remodeling of the media.
It has been recently shown in acute animal experi-
ments that the H-wave" (Electronic WaveForm Lab,
Huntington, Beach, California) device stimulation
(HWDS) induces a nitric oxide (NO)-dependent
increase in microcirculation of the rat Cremaster skele-
tal muscle [7]. Moreover, chronic HWDS of rat hind
limbs not only significantly increases blood flow (above
247% from baseline) but induces measured angiogenesis
[7]. Coupling these findings strongly suggests that
HWDS promotes rapid and complete healing without
the need of expensive surgical procedures. With this in
mind, we decided to preliminary evaluate H-Wave"
device therapy and program in three seriously inflicted
diabetic patients with chronic venous stasis ulcers.

Case presentation
Methods
In this preliminary case series we selected three ser-
iously inflicted patients with chronic venous stasis
ulcers. Each patient signed an informed consent. The
study was evaluated and approved by the Path Research
Foundation IRB committee (NIH registration
#IRB0002334). The study was designed and executed by
one of us (MSA) and subsequently approved by the
other authors. The setting for this case study was
LACUSC Medical Center. In each case the location and
size in cm were denoted pre and post H-Wave" treat-
ment. At initial contact each patient was dispensed a
home H-Wave" device and provided follow-up instruc-
tion by a representative. There were three different sce-
narios executed in this study: 1) H-Wave" therapy alone;
2) H-wave" therapy with traditional compression ther-
apy; 3) H-Wave" therapy and weekly wound care.

H-Wave Therapy Regimen
Patient one received a two-channel home H-wave"
device at the beginning of the study period and used it
throughout. Patient two received only once weekly treat-
ments with the three channel clinical H-wave" device.
Patient three started with once weekly clinical H-wave"
treatments, but after nine months received a home H-
wave" device to use daily in addition to once weekly
treatments.
Home treatment was given with a two channel portable
H-wave" device. The patient was instructed to self treat for
at least one hour per day. The pads from the first channel
were placed on the quadriceps muscle of the affected leg.
The pads from the second channel were placed on the
gastrocnemius and over the head of the fibula. The fre-
quency dial of the H-wave" device was set to minimum (1-


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2 Hz) to create rhythmic non-fatiguing muscle contrac-
tions. The intensity dial was increased to at or near maxi-
mum to create strong muscle contractions.
In clinic treatment was given with a three channel
clinical H-wave" device.
Treatment times were between 30 and 60 minutes. The
pads from the first channel were placed on the quadri-
ceps muscle of the affected leg. The pads from the sec-
ond channel were placed on the gastrocnemius and over
the head of the fibula. The pads from the third channel
were placed on the top and bottom of the foot. The fre-
quency dial of the H-wave" device was set to minimum
(1-2 Hz) to create rhythmic non-fatiguing muscle con-
tractions. The intensity dial was increased to at or near
maximum to create strong muscle contractions.
Both H-wave" models have identical waveforms and
output parameters, the difference is only in the number
of output channels and therefore electrodes that can be
placed one the skin.

Wound Care Procedure
Our approach to the utilization of standard wound care
was palliative in nature. Thus this approach can be sum-
marized with the mnemonic S-P-E-C-I-AL (S = stabiliz-
ing the wound, P = preventing new wounds,
E = eliminate odor, C = control pain, I = infection pro-
phylaxis, A = advanced, absorbent wound dressings, L =
lessen dressing changes) as described by Alvarez et al.
[8]. Our approach to wound healing was based on the
National Guideline Clearinghouse report and recom-
mendations. The report included summary algorithm
for venous ulcer care with annotations of available evi-
dence [9]. The diagnosis of venous stasis ulcers was
confirmed by the following process:
1) Patient history prior phlebitis, deep vein thrombo-
sis, lower leg swelling/edema, ache or tiredness in leg,
trauma/intimal damage, maternal venous ulcer
2) Differential diagnosis Plethysmography, elevated
temperature
3) Physical exam clinical severity, etiology, anatomy,
pathophysiology, edema, stasis dermatitis, measure ulcer
size. The following standard of care was adopted in the
wound care procedure: manage of peri-wound skin,
local wound care, maintain moist wound environment
for healing or venous ulcer pain management, antimi-
crobial wound care and dressings. Patients) that
received compression therapy conformed to standard
practice as denoted by Arnold et al. [10].

Inclusion/exclusion criteria
It is noteworthy that all of these patients were uninsured
and were treated free of charge. The three patients were
part of an approved IRB larger study. The the three


patients were ambulatory out-patients and met all cri-
teria for inclusion of this study.

Inclusion
One major inclusion criteria into the study was that
each patient had to have diabetes for more than 24
months. They had to be ambulatory and not satisfied
with any previous treatment. All patients had to have
chronic venous stasis ulcers.

Exclusion
The main purpose of this series was to assess the bene-
fits of administering the H-wave" device" in the treat-
ment of chronic diabetic ulcers. Therefore, we utilized
strict inclusion criteria which was approved as part of
the larger study. Exclusion consisted of having: serious
co-morbid cardiovascular problems, arterial insuffi-
ciency, cancer of any type, addiction to any psychoactive
drug, or be currently taking medications for existing
conditions other than anti-diabetic agents.
None of the patient's underwent angiographic assess-
ment of their lower limb circulation or other techniques
such as prostaglandin analogues.

Results
The following information is provided on each patient
including the actual progression of healing of the ulcer.
This information was obtained by the staff of clinic at
LACUSC Medical Center under the clinical supervision
of MSA.
Case report 1
The first patient was a 58 year old Caucasian male with a
chronic venous stasis ulcer of the lateral ankle. This
patient had a history of vein stripping surgery in 1992
and multiple leg ulcerations. The patient was referred to
the LACUSC Medical Center Clinic because of his non-
healing ulcerated wound. At the initial contact on 11-09-
98 the ulcer size measured 5.5 cm L. x 3.5 cm W x 3
mm deep with an ankle circumference of 28 cm (See fig-
ure 1 photo A). At this date the patient was dispensed a
home H-wave" unit. On 11-23-98, figure 1 photo B
shows the improvement following home H-Wave" ther-
apy used daily for two weeks. In addition this patient was
seen weekly for wound care and light compression ther-
apy. At this date the ulcer size measured 3.5 cm L x 3.5
cm W x 2 mm deep with an ankle circumference of 26
cm. On 11-27-99, figure 1 photo C shows healing of
about 75% or distal two-thirds of ulcer has closed after
2.5 months of home H-Wave" therapy. At this date the
ulcer size measured 3.5 cm L x 1 cm W at widest 0.5 cm
at smallest W x 1 mm deep and spoon shaped. Finally on
2-17-99, Figure 1 photo D shows complete healing of
ankle ulcer after 3 months of H-Wave" therapy.


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PATIENT 1


Initial Patient Contact: 11-09-98


PIHT A
"58 year old male with a chronic vonnus, stasis uakcr for 6 wars.. He ha, a
history of eiri stripping miremr in 1992 and 0lUli[ip!e Ilt ulcraLions.
Patienti refrred tL itur clinic hccause of hisi nonhcaling wouiul,"


Ulcer Lxatiun: I.aeral anklc
Ulcer Size: 5-.5 cin L x 1.5 cm W x 3 mm detp.
An kle c I um6:=ncc : !X cm
A Lonme H-Wlae unull Nia dispensud.


PHOTO B

-'Home H-Wawe Ihcrapy otti i zerd daih, for Ib~ A o tks:'
Patientl seen wifrkly forW Ov~nd ramand ln liehi compresision, lierpy,

Ulcer Siz,- 35 cmgi i. L 3_5 cm W % 2 mm deii.
Ankle circuflLer1ifncc: 26 1ii,
1123-959

PHOTO C

I Iuuwc I I-Wavie ii.:rj p with healing ofLhoul 75% oif alwkr,"
Ulcter Si/c: S poon hapcd. -.5 cm 1. x I cm W at widcNI 1.5 cm in
mallsct W x I mm] deep.

Distal Itwothlrds or ulcer hasilosed ualvr 2.5 munth-s of HIome


PHOTO D


'"U~er healed after 3 months of Home H-Wave therapy."



2-17-990

Figure 1 Cumulative Wound healing pictures of Patient #1.


Case report 2
The second patient was a 47 year old African-American
male with a chronic venous stasis ulcer of the medial
ankle. This patient had a history of recurrent leg ulcera-
tions. The last ulceration in 1996 took one year to heal.
The patient was referred to the LACUSC Medical Cen-
ter Clinic because of his non-healing ulcerated wound.
At the initial contact on 4-14-98 the ulcer size measured
3.0 cm L. x 2.0 cm W x 3 mm deep with an ankle cir-
cumference of 25 cm (See figure 2 photo A). On 4-28-
98, figure 2 photo B shows the improvement of greater
than 50% following H-Wave" therapy after 3 H-wave"
sessions. The patient received once a week H-wave"


therapy at the clinic. In addition this patient received
traditional compressive therapy. At this date the ulcer
size measured 1.2 cm L x 0.7 cm W x 1 mm deep with
an ankle circumference of 22 cm. On 5-05-98, figure 1
photo C shows continued closure after 4 H-wave" ses-
sions. At this date the ulcer size measured 3.0 mm L x
5 mm W x less than 1 mm with an ankle circumference
of 22.5 cm. and spoon shaped. Finally on 5-12-98, Fig-
ure 1 photo D shows complete healing of ankle ulcer
after one month of once weekly of H-Wave" therapy.
Case report 3
The third patient was a 52 year old African American
male with a chronic venous stasis ulcer of the medial


Page 4 of 8


11a-09m 8


V**




r







Blum et al. Cases Journal 2010, 3:54
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PATIENT 2


Initial Patient Contact: 4.14.98


PHOTO A
`47 year old male widi a chirmic sasis ulcer for three weeks. The patient
has a history of recurrent le ulceralion. Last ulceration in 1996, which
look une year to heaL"

Ulcer Iicaiion: IMidial ankle
Ulcer Size: 3.0 cm x 2,0 cm W x 3 mrm deep
Ankle circumrfecrne: 25 cm

4-14-98 )

PHOTO B

"Greiar ihan 50%f dlucton, after 3 H-Wave sessions."
Ul-er Siz.e: 1.2 cm L x 0,7 cm W x I mm deep.
Ankle circumference: 22 cm

Patient has received once a week TH-Wave therapy, with
traditional cornpresive therapy.
4-28-98

PHOTO C

"Continiued ulcer closure afler 4 H-Wave s~sseons,"
Ulcer Size: Sprorn .haped, 3 mm L 5 mm W x less than I n1111 deep
Ankle circumference: 22.5 cm


5-os05-98 )

PHOTO D


"Complete ulcer closure after one month of once weekly H-Wave
therapy.'




5-12-98 )

Figure 2 Cumulative Wound healing pictures of Patient # 2


ankle for 2 years. The patient was referred to the
LACUSC Medical Center Clinic because of his non-
healing initial contact on 07-21-98 the ulcer size mea-
sured 6.0 cm L. x 5.0 Cm W x 0.6 mm deep with an
ankle circumference of 29 cm (See figure 3 photo A). At
this date the patient was dispensed a home H-wave"
unit. On 04-20-99, figure 3 photo B shows the improve-
ment following home H-Wave" therapy utilized once a
week in the clinic. In addition this patient was seen
weekly for traditional compression therapy. At this date
of eight months of traditional compression therapy and


once a week therapy the ulcer size measured 2.5 cm L x
2.5 cm W x 1 mm deep with an ankle circumference of
26 cm. Moreover at this date home H-Wave" therapy
was added including weekly wound care. On 04-27-99,
figure 3, photo C shows healing improvement after one
week of home H-Wave" therapy. At this date the ulcer
size measured 1.5 cm L x 1 cm W x less than 1 mm
deep with a circumference of 25 cm. Finally on 5-11-99,
Figure 3 photo D shows complete healing of ankle ulcer
after 9 months of H-Wave" therapy and weekly wound
care.


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PATIENT 3


Initial Patient Contact: 07-21-98


PHOTO A
"52 year old IriuLO with a chrorkiL ell(Ms Ma'il. ulcer for 2 years. Pacient



U lcur Uiicati4m: N-ediall a nkle
U Icrr Sue: 6.0 cm L x 5A) cm W x 0.6 cm ictp-
Ankle irnutiIrrn e: 29 cm


07-21-98 )


PHOTo B


"Eight tnornh, t f lradiliomti Conipressioi therapy and once a wcek
H-Wa-e therapy:"

L'1cr k S i/c. 2.5 cm L K 2.5 cim W x I fint dcp,
Ankle citcuniference: 26 cm

New tm 7LAtment addlvd: Norn HA% ai i th erarn.~ 4.20-99


PHOTO C

"Ituproved U'k,:r h'.lii- afler one week of 11om0e H1-Wake therapy"

Ulcer Size: 1.5 cm L K I.0 cin W x Ied chan I mm deep.
Ankle :ii'.timi, wiici 25 cin

Reeullor uu of Howe H-Wove Iherapy and weekly wound care.

4-27-99 )

PHOTO D

-U1cer completely Ilealed after 9 nornihs of weekly wound care and
H-V4LvL! Lht!niPY.

Wound healing was acelierated with consistent and additiornal use
of H1omre H-Wave therapy.

5-11-99)


Figure 3 Cumulative Wound healing pictures of Patient # 3


Discussion
This is the first study that has investigated the effects of
HWDS in wound healing and in particular venous stasis
ulcers. It is our contention the effects observed in this
case series is not surprising in light of the mechanism
by which HWDS increases microcirculation in rat


experiments [7]. Moreover, nitric oxide is profoundly
involved with wound healing by virtue of its effects to
control blood flow to tissues and anti-inflammatory
effects to influence pain [11]. Interestingly, wound heal-
ing represents a particularly challenging clinical problem
to which no efficacious treatment regimens currently


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- B


rb'







Blum et al. Cases Journal 2010, 3:54
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exist. Although protein-type mediators are well estab-
lished players in this process, emerging evidence from
both animal and human studies indicates that nitric
oxide plays a key role in wound repair. The beneficial
effects of nitric oxide on wound repair may be attribu-
ted to its functional influences on angiogenesis, inflam-
mation, cell proliferation, matrix deposition, and
remodeling [12,13]. The H-wave" nitric oxide rat study
revealed that the increase in microcirculation induced
by H-wave" was blocked by the nitric oxide receptor
inhibitor L-NAME (N-monomethylarginine), indicating
a nitric oxide-dependent response. It is well established
that angiogenesis plays an important role during adult
life span, and it is primarily involved in tissue repair
mechanisms [14]. Angiogenesis heals injured or frac-
tured body parts by activating genes which ultimately
leads to the production of the angiogenic factors such as
Vascular Endotherial Growth Factor [VEGF] [15].
Understanding physiological processes involved in
wound healing along with the findings related to both
nitric oxide dependent increases in microcirculation, as
well as significant induction of angiogenesis following
chronic HWDS in rats provides a clear mechanism for
the H-wave" positive effects.

Conclusion
Approximately 15% (more than 2 million individuals) of
all people with diabetes will develop a lower-extremity
ulcer during the course of the disease. While most of
these ulcers can be treated successfully on an outpatient
basis, a significant proportion will persist and become
infected. Based on this preliminary case series investiga-
tion we found that three patients prescribed H-Wave"
home treatment demonstrate accelerated healing of
chronic venous stasis of ankle ulcers with excellent
results. While these results are encouraging, additional
large scale investigation is warranted before any inter-
pretation is given to these interesting outcomes.

Consent
Written informed consent was obtained from the
patients for publication of this case report and accompa-
nying images. A copy of the written consent is available
for review by the Editor-in-Chief of this journal.


Acknowledgements
This work was supported by Electronic Waveform Labs, Huntington Beach,
California The authors appreciate the arduous work of the entire LACUSC
Medical Center staff The authors would like to thank the staff of Path
Research Foundation

Author details
'Department of Psychiatry, University of Florida College of Medicine,
Gainesville, FI, USA 2Engineering & Management of Advanced Technology,
Chang Jung University, Taiwan, Republic of China Department of
Occupation Health and Safety, Chang Jung University, Taiwan, Republic of


China 4Department of Neurosurgery, Weill Cornel School of Medicine, New
York, NY, USA sDepartment of Clinical Reearch, Path Reearch Foundation,
New York, NY, USA 6Department of Personalized Medicine, Synaptamine,
nc San Antonio, Texas, USA 'Nautilus, Inc Vancouver, WA, USA
Department of Holistic Medicine, G&G Holistic Addiction Treatment Center
(Pain Track) North Miami Beach, Florida, USA Department of Orthopedic
Surgery, Hospital of the University of Pennsylvania, Philadelphia, PA, USA

Authors' contributions
KB developed the writing of the manuscript and directed the publication
submission; ALCC contributed to the overall writing of the manuscript and
provided comments; TJHC contributed to the literature background and
edited the manuscript; BWD contributed to the overall edits of the
manuscript and provided important concepts; ERB was responsible for the
RB approval and clinical direction; MK contributed to the overall submission
of the manuscript and provided important editorial feedback and
development of journal formatting; SS provided important feedback and
developed the informed consent forms; AB contributed to editorial review
of the final manuscript; MM provided important information on wound care;
SHB provided literature search and reference checking including editorial
comments; GR provided important conceptual physiological directed
comments and literature search; JG provided editorial review of the fina
manuscript; ND provided important editorial and conceptual comments and
consulted on appropriate wound care parameters All authors read and
approved the final manuscript

Competing interests
While KB, GR and ND are paid consultants of Electronic Waveform Labs,
Huntington Beach, California, they do not have any ownership There is no
other conflict of interest related to this data

Received: 30 November 2009
Accepted: 10 February 2010 Published: 10 February 2010

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doi:10.1186/1757-1626-3-54
Cite this article as: Blum et al Healing enhancement of chronic venous
stasis ulcers utilizing H-WAVE* device therapy: a case series. Cases
Joumal 2010 3 54


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