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Role of Pulsed Magnetic Field (PMF) Therapy in the Management of Diabetic Foot Disease

Authors:

Abstract

Pulsed Magnetic Field (PMF) treatment modality is a valuable adjuvant therapy for diabetic foot. It has been shown that PMF therapy has antiinflammatory properties, heals injured tissues & gives relief to pain. PMF acts at cellular level & this energy gets converted to positive physiological responses. The evidence based mechanism involving PMF activation of the calcium/calmodulin/ nitric oxide/growth factor pathway , which reduces inflammation & activates healing process . The three important parameters for PMF therapy are frequency in 1-10 Hz range, amplitude around 1500 nanoTesla and Wave form being Sine & Square. PMF therapy is found to have therapeutic efficacy, especially in the initial stages of diabetic neuropathy and in patients with diabetic foot ulcers. PMF as adjuvant therapy predominantly can serve as an out-patient service in primary and secondary care of diabetic foot disease. Being a low cost technology, the primary advantages of PMF therapy are it is non-invasive, simple and adopts safe procedures.
TAPI Journal Vol. 11, Issue 1, January – April 2019
17
RoleofPulsedMagneticField(PMF)Therapyinthe
ManagementofDiabeticFootDisease
ShivakumarS*andDhilipKS
MadrasInstituteofMagnetobiology,Chennai,India
*Correspondingauthor:drshivakumarsingh@gmail.com
Abstract
Pulsed Magnetic Field (PMF) treatment
modality is a valuable adjuvant therapy for diabetic
foot. IthasbeenshownthatPMFtherapyhas
antiinflammatoryproperties,healsinjured
tissues&givesrelieftopain.PMF acts at cellular
level & this energy gets converted to positive
physiological responses. The evidence based
mechanism involving PMF activation of the
calcium/calmodulin/ nitric oxide/growth factor
pathway. The three important parameters for
PMF therapy are frequency in 1-10 Hz range,
amplitude around 1500 nanoTesla and Wave form
being Sine & Square. PMF therapy is found to
have therapeutic efficacy, especially in the initial
stages of diabetic neuropathy and in patients with
diabetic foot ulcers. PMF as adjuvant therapy
predominantly can serve as an out-patient service
in primary and secondary care of diabetic foot
disease. Being a low cost technology, the primary
advantages of PMF therapy are it is non-invasive,
simple and adopts safe procedures.
Introduction
In recent times, the life expectancy of
people with disabilities has increased. It is
important to ensure that these added years of life
are accompanied with improvements in health
related quality of life. Medical and technological
advances, surgical intervention and
pharmacotherapy have played an important role in
improving the health and quality of life for people
with disabilities. The World Health Organization
(WHO) noted that ‘adding years to life’ is an
empty victory without ‘adding life to years’.
Diabetes is projected to become one of the
world's main disablers within the next twenty-five
years. Diabetic foot is a major complication of
diabetes mellitus and is the second leading cause
of amputation foot after traumatic amputation.
Diabetic foot presents as peripheral neuropathy
and foot ulcers. Diabetic foot ulcers are due to
peripheral neuropathy, peripheral vascular disease
and infection. Management of diabetic foot
consists of control of diabetes by oral
hypoglycemic drugs / insulin, antibiotics for
infection, surgical treatment and offloading
techniques for foot. Additionally, Pulsed Magnetic
Field (PMF) treatment modality can be a valuable
adjuvant therapy for diabetic foot. It has been
shown that PMF therapy has anti
inflammatory properties, heals injured tissues
& gives relief to pain. Pulsed Magnetic Field
(PMF) treatment modality may present as an
effective, low-risk intervention increasing the
chances of maximizing benefit for people with
impaired healing. Future advances in this area of
therapy hold great promise and are expected to
unfold.
Pulsed Magnetic fields (PMF), has been
known to have beneficial effects on the human
body. Ultra low intensity, extremely low frequency
& highly homogenous pulsating magnetic field in
a non invasive manner have been used for treating
various diseases. Specifically, PMF Therapy has
been found to be useful in the management of
diabetic foot diseases. It reduces pain in diabetic
peripheral neuropathy and heals diabetic foot
ulcers by reducing inflammation and activating
healing process. Several studies have proved
the positive effect of PMF on wound closure
[1-3].
Madras Institute of Magnetobiology –
Technology Progenitors
The Madras Institute of Magnetobiology
(MIM) in Chennai, Tamilnadu, India has done
TAPI Journal Vol. 11, Issue 1, January – April 2019
18
research on PMF’s for the past three decades
(1984 -2014). MIM is the only institution of its
kind in South East-Asia devoted exclusively to
studies on the possible control of Pulsed Magnetic
fields (PMF) of extremely low frequencies (ELF)
and ultra low intensities, on test animals and
volunteer human subjects. Experiments, funded
by the Indian government’s Department of
Science and Technology, yielded exciting results
indicating that magnetic fields in pulsed form
interact with and elicit response from biological
systems. Registered as a scientific society in 1984,
the “Madras Institute of Magnetobiology” (MIM)
has, over the last three decades, made milestone
contributions in this arena. During the last two
and a half decades several governmental agencies
and organizations such as the Defence Ministry,
Environment Ministry, Dept. of Science and
Technology, ICMR & CSIR have supported the
Institute’s R&D efforts through research projects
of specific duration and MIM has provided
comprehensive technical reports on findings in
these studies. Research efforts such as the above
have resulted in land mark publications and as
proceedings in national and international
conferences. In recognition of the efforts, the
Directorate of Medical Education, State Health
Dept., on orders from Dept. of Health and Family
Welfare, Govt.of.India, has recommended the
application of results of research effort by Madras
Institute of Magnetobiology for treatment of
diseases in human beings.
More than 5000 patients have been
treated at its O/P centre during this period for
chronic musculoskeletal disorders, diabetic
neuropathy and foot disease, certain neurological
diseases and geriatric ailments. The main
contribution of this Institute being extremely low
frequency and ultra low intensity magnetic fields
are adequate to elicit very good biological
response in damaged tissues [4].
PMF Therapy Device – Description,
Parameters and Usage
The therapy is delivered by an equipment
called PULSATRON (Fig-1) designed by the
Madras Institute of Magnetobiology, which
generates highly homogeneous Extremely Low
Frequency Ultra Low Intensity magnetic fields in
pulsed form inside specially fabricated Controlled
Magnetic Field (CMF) enclosures carrying
alternating currents. The CMF enclosure consists
of four member coil assembly being a modified
Fanselau & Braunbeck system with a two set
circular coils array, the inner two being of larger
diameter and the outer two of smaller diameter
generating the desired magnetic field.
The three important parameters for PMF therapy
by PULSATRON as it were:
1) Frequency: in 1-10 Hz range
2) Amplitude: around 1500 nanoTesla
3) Wave form: being Sine & Square
The duration of treatment per day vary
from 30 to 120 minutes daily. The total duration
of therapy can range from 21 to 45 days. Repeat
therapy (Booster) are given after 3 months if
found necessary [5]. The contra-indications for
PMF therapy are pregnancy and implanted
electronic devices.
Fig-1. PMF Therapy - PULSATRON
PMF – Mode of Action
PMF acts at cellular level and this energy
gets converted to positive physiological responses.
The evidence based mechanism involving PMF
activation of the calcium/calmodulin/ nitric oxide
pathway which suppresses IL-1beta causing anti
inflammatory response & stimulating growth
factors such as VGEF & TGF-Beta leading to
angiogenesis & cell growth is gaining wide-
acceptance apart from the many other mechanism
of cell activation proposed [6].
TAPI Journal Vol. 11, Issue 1, January – April 2019
19
Diabetic Foot – Role of PMF
Various studies have revealed the benefit
of PMF therapy in diabetes. Vinay Graak et al
choose thirty subjects within an age group of 40–
68 years with diabetic polyneuropathy stages N1a,
N1b, N2a (as defined by Dyck and Thomas
classification), randomly allocated to groups 1, 2, 3
with 10 subjects in each. Group 1 and 2 were
treated with PMF. Group 3 served as control on
usual medical treatment of diabetic
polyneuropathy. Significant reduction in pain and
statistically significant (P<0.05) improvement in
distal latency and nerve conduction velocity were
seen in experimental group 1 and 2[7].
Kwan et al treated patients with diabetic
foot ulcer. By the end of the treatment period,
there was an 18% decrease in wound size in the
active PMF group as compared with a 10%
decrease in the control group. The PMF group
demonstrated significant cumulative increase in
cutaneous capillary blood velocity (28%) and 14%
increase in capillary diameter. In contrast, the
control group showed a decrease in both capillary
blood velocity and diameter [8].
Weintraub et al conducted a study on
Pulsed magnetic field therapy in refractory
neuropathic pain secondary to peripheral
neuropathy. The study data demonstrated that
directing PMF to refractory feet can provide
unexpected short term analgesic effects in more
than 50% of individuals. The precise mechanism
is unclear yet suggests that severe and advanced
cases are more magnetically sensitive. Future
studies are needed with longer treatment periods
[9].
Musaev et al studied the use of pulsed
electromagnetic fields in the treatment of patients
with diabetic polyneuropathy. Clinical and
electroneuromyographic studies were performed
in 121 patients with diabetic polyneuropathy
(DPN) before and after courses of treatment with
pulsed electromagnetic fields with complex
modulation (PMF-CM). The earliest and most
significant electroneuromyographic signs of DPN
were found to be decreases in the amplitude of the
H reflex and the Hmax/Mmax ratio in the
muscles of the lower leg. Application of PMF-CM
facilitated regression of the main clinical
symptoms of DPN, improved the conductive
function of peripheral nerves, improved the state
of la afferents, and improved the reflex excitability
of functionally diverse motoneurons in the spinal
cord. PMF-CM at 10 Hz was found to have
therapeutic efficacy, especially in the initial stages
of DPN in patients with diabetes [10].
In a study conducted in 16 American
academic and clinical centres [11], low-frequency
pulsed electromagnetic fields were applied onto
the feet of patients with stage 2 or 3 diabetic
polyneuropathy. Patients exposed to pulsed
electromagnetic field exhibited a trend toward
reductions in diabetic polyneuropathy symptoms
on the Patient’s Global Impression of Change
scale (PGIC) as well as increased epidermal nerve
fibre density which was significantly correlated
with decreases in analogue pain scores.
Our Experience in Diabetic Foot
In a collaborative study between MIM,
Institute of Physiology and Institute of
Diabetology, Madras Medical College, Chennai,
PMF was utilized for the treatment of patients
with diabetic foot ulcer (Wagner 1 and 2) for a
period of 30 days and found good healing rates in
Test group compared to Control. In a study of
patients with painful diabetic neuropathy,
significant reduction in neuropathic pain was
observed in PMF treated group. The studies
revealed in the PMF treated group, improved
peripheral circulation of foot in painful diabetic
polyneuropathy, reduction in pain and influenced
nerve conduction. It also reduced oxidative stress
by increasing Super Oxide Dismutase (SOD)
levels. PMF therapy addressed the pathogenesis of
diabetic neuropathy rather than merely focusing
on pain alleviation. In case of Foot ulcers, there
was significant reduction in wound surface area.
Wound dimensions such as length, width, surface
area and depth decreased significantly. Healthy
granulation tissue and reduction in exudates were
also observed. Significant elevation in Serum
VEGF le
v
were repo
therapy e
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ishwanathan
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[14].
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s
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i
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V
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ulcers (Wag
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nexposed
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ournal Vol. 11,
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earch Center
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Issue 1, Jan
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PM
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uary – April 20
F
therapy can
e
tic neuropat
h
a
voidance o
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dary compl
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o
rs, reductio
n
n
cial burden,
t
er personal p
advantages
m
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l
1
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2
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n
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n
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r
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tes and its c
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n
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nistrators m
u
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ment option
s
m
echanism t
o
d
uces the bes
t
d
ing will
h
r
ventions in
l
ting in the m
o
f
unctionally.
Newer t
h
e
user-friend
l
have started
in specialist
h
p
atient clinics
F
as ad
j
uvant
t
n
out-patient
s
of diabeti
c
h
asized that
F
therapy app
e
19
be valuable
i
h
y and diabet
i
f amputatio
n
i
cations by
b
n
in treatm
e
improved
Q
roductivity.
of PMF
l
ows;
technolog
y
n
dl
y
n
d safe proce
d
a
sive
e
nt service
therapy
n
ctional
by paramedi
c
is an e
n
is needed t
o
n
troduce cost
r
se this trend.
on the fin
a
o
mplications
p
n
uing to rise,
u
st take the
s
for patients
o
identify t
h
t
health outc
o
h
elp to d
terms of
c
o
st superior
o
h
erapy devices
l
y and chea
p
to become
m
h
ospital depa
or even in
t
t
herapy pred
o
s
ervice in pri
m
c
foot disea
amongst the
e
ars to be m
o
i
n the treatm
e
i
c foot ulcer l
e
n
, eliminati
o
b
ringing dow
n
e
nt costs, re
Q
uality of Li
f
therapy ca
n
d
ures
c
al personnel
xpensive d
i
o
stem the t
i
effective tre
a
WHO has
a
a
ncial burde
n
p
oses. With c
Indian healt
h
cost of di
f
into conside
r
h
e treatmen
t
o
mes with av
a
etermine s
u
c
ost and e
f
o
utcome, fina
n
are now bec
o
p
er. Conseq
u
m
ore availabl
e
rtments but
a
t
he patient’s
h
o
minantly can
m
ary and sec
o
se. It shou
l
new interve
n
o
st safe for us
e
e
nt of
e
ading
o
n of
n
risk
duced
f
e and
n
be
i
sease.
i
de of
a
tment
a
lready
n
that
ost of
h
care
f
ferent
r
ation.
t
that
a
ilable
u
itable
f
ficacy
n
cially
o
ming
u
ently,
e
, not
a
lso at
h
ome.
serve
o
ndary
l
d be
n
tions,
e
with
TAPI Journal Vol. 11, Issue 1, January – April 2019
21
very few contraindications in the management of
diabetic foot disease.
Reference
1. Callaghan MJ, Chang El, Seiser N et al. Pulsed
Electromagnetic Field accelerates Normal and Diabetic
Wound healing by increasing endogenous EGF-2
release. Plast Reconstr Surg 2008:121:130-141.
2. Guerriero F, Botarelli E et al. Effectiveness of
innovative pulsed electromagnetic field stimulation in
healing of untreatable skin ulcers in frail elderly: case
reports. Case Rep Dermatol Med 2015;2015:1-6.
3. Choi M Cheung K, Li X, Cheing GL. Pulsed
Electromagnetic Field promotes collagen fibre
deposition associated with increased myofibroblast
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Arch Dermatol Res 2016;308:21-29.
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Magnetobiology , Chennai - 2016 Guidelines.
DOI:10.13140/RG.2.2.14964.76162. Nov., 2016.
6. Berish Strauch, Charles Herman, Richard Dabb, et al.
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Data
Full-text available
The role and impact of Pulsed Magnetic Field (PMF) therapy in certain geriatric ailments was assessed at "ANANDAM"-a senior citizen center located at Ambattur, a suburb of Chennai, Tamilnadu, South India. Several studies related to cellular and biophysical mechanisms along with the clinical implications of Extremely Low Frequency & Ultra Low Amplitude magnetic fields, described generally as pulsed magnetic fields, have shown their adequateness in eliciting very good biological response in damaged tissues. Use of such Pulsed Magnetic Fields (PMF) now as a tool of therapy is getting accepted as part of modern holistic health care for two most important reasons; non-invasiveness and being side effect free, a boon when treating geriatrics. In its medical research publications, the Madras Institute of Magnetobiology (MIM) has given its experience with PMF therapy. Spanning more than two decades, more than 50% of their patients treated have had geriatric disorders. For this study, 131 patients from MIM & 29 patients from Anandam in the age group between 50-90 years were grouped under 3 categories based on the nature of problem exhibited : Musculoskeletal Pain (MSP), Wound healing and Peripheral neuropathy. Post PMF therapy, all patients with Musculoskeletal diseases experienced pain relief and greater physical functional autonomy. Regarding wound healing there was significant healing ranging from 80% to total wound closure. All peripheral neuropathy patients exhibited significant improvement as evidenced from Biothesiometry study, hot/cold perception test and monofilament tests conducted pre and post PMF treatment. The results show promising therapeutic effectiveness in treating geriatric disorders. Integrating PMF therapy as an adjuvant into existing geriatric medicare can help the elderly experience "healthy aging".
Data
Full-text available
PEMF therapy has anti inflammatory effects , heals injured tissues & gives relief to pain . The mechanism of action is activation of the Calcium / Calmodulin / Nitric oxide / Growth factors pathway which reduces inflammation & heals injured tissues . At the Madras Institute of Magnetobiology , PEMF therapy has been utilized for treatment of Musculoskeletal disorders , Diabetic foot & neurological diseases . Pulsed ultra low frequency , low amplitude magnetic field has has been utilized for management . The 2016 protocol has the following features - Frequency : 10Hzs ; Amplitude : 1500 nano Tesla & Wave form : Sine / Square . The duration is 1-2 hours daily & is for 21 - 45 days. PEMF was useful in the management of 1) Musculoskeletal disorders : Osteoarthritis of knee joint , Seronegative & Rheumatoid arthritis , cervical & lumbar spondylosis , Fracture & soft tissue injury healing , 2) Diabetic foot disease : painful Diabetic neuropathy , Diabetic foot ulcer healing , 3) Neurological diseases : Migraine , Depression , Stroke Rehabilitation & Parkinson's disease . PEMF therapy is non invasive , simple , safe & cost effective adjuvant therapy for various ailments. The Guidelines & the protocol for the treatment of various diseases in various specialities have been highlighted .
Article
Full-text available
Introduction. Recalcitrant skin ulcers are a major burden in elderly patients. Specifically, chronic wounds result in significant morbidity and mortality and have a profound economic impact. Pulsed electromagnetic fields (PEMFs) have proved to be a promising therapy for wound healing. Here we describe the first reported case of an innovative PEMF therapy, Emysimmetric Bilateral Stimulation (EBS), used to successfully treat refractory skin ulcers in two elderly and fragile patients. Case Presentation. Two elderly patients developed multiple chronic skin ulcerations. Despite appropriate treatment, the ulcers showed little improvement and the risk of amputation was high. Both patients underwent daily EBS therapy and standard dressing. After few weeks of treatment, major improvements were observed and all ulcers had healed. Conclusion. In patients with refractory ulceration, EBS therapy may be of real benefit in terms of faster healing. This case supports the supportive role for PEMFs in the treatment of skin ulceration in diabetes and is suggestive of a potential benefit of EBS in this clinical condition.
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Absract: This article brings about Madras Institute of Magnetobiology (MIM) experience with Pulsed Magnetic Field (PMF) therapy on several ailments during the period 2004 to 2013. The PMF therapy technique at MIM consists in sweeping or "bathing" the entire body or individual limbs / sections in a highly uniform magnetic field of very low intensity ( 1500 nT ) pulsing at extremely low frequency ( 1 - 10 Hz ) using Controlled Magnetic Field enclosures (PULSATRON R). The common diseases treated were Musculoskeletal disorders , Diabetic foot & Neurological diseases . PEMF gives relief to pain , has anti - inflammatory effects & heals injured tissues . Off the 899 patients taken up for retrospective analysis during the period 2004 to 2013, 160 patients discontinued the PMF treatment for various reasons. Out of the balance 739 patients, 727 of them showed improvement in their condition. With a success rate of 87% in cervical spondylosis, 80% in lumbar spondylosis, 78% in osteo arthritis of knee joint and 85% in polyarthritis category, MIM has obtained good results in the treatment of chronic musculoskeletal disorders with PMF therapy. In Cerebral Palsy cases (children with spastic diplegia), there was significant reduction in grade of spasticity (60%) and in post-PMF therapy re-assessment done after 30 days, persistent effect of grade reduction in spasticity was seen. As regards fracture healing, patients who completed the course of PMF treatment had reduction in pain, swelling, improved range of movement and healing. There was substantial success in diabetic ulcer healing with two-thirds of the patients having 70% reduction in wound surface area. In the treatment of Parkinson's disease there was improvement in gait disturbances, tremor and rigidity in all patients and in spasticity in Hemiplegia patients. Overall, the results highlight the role of PMF therapy as a viable adjuvant modality for several ailments.
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Clinical and electroneuromyographic studies were performed in 121 patients with diabetic polyneuropathy (DPN) before and after courses of treatment with pulsed electromagnetic fields with complex modulation (PEMF-CM) at different frequencies (100 and 10 Hz). Testing of patients using the TSS and NIS LL scales demonstrated a correlation between the severity and frequency of the main subjective and objective effects of disease and the stage of DPN. The severity of changes in the segmental-peripheral neuromotor apparatus--decreases in muscle bioelectrical activity, the impulse conduction rate along efferent fibers of peripheral nerves, and the amplitude of the maximum M response--depended on the stage of DPN and the duration of diabetes mellitus. The earliest and most significant electroneuromyographic signs of DPN were found to be decreases in the amplitude of the H reflex and the Hmax/Mmax ratio in the muscles of the lower leg. Application of PEMF-CM facilitated regression of the main clinical symptoms of DPN, improved the conductive function of peripheral nerves, improved the state of la afferents, and improved the reflex excitability of functionally diverse motoneurons in the spinal cord. PEMF-CM at 10 Hz was found to have therapeutic efficacy, especially in the initial stages of DPN and in patients with diabetes mellitus for up to 10 years.
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Chronic wounds, particularly in diabetics, result in significant morbidity and mortality and have a profound economic impact. The authors demonstrate that pulsed electromagnetic fields significantly improve both diabetic and normal wound healing in 66 mice through up-regulation of fibroblast growth factor (FGF)-2 and are able to prevent tissue necrosis in diabetic tissue after an ischemic insult. Db/db and C57BL6 mice were wounded and exposed to pulsed electromagnetic fields. Gross closure, cell proliferation, and vascularity were assessed. Cultured medium from human umbilical vein endothelial cells exposed to pulsed electromagnetic fields was analyzed for FGF-2 and applied topically to wounds. Skin flaps were created on streptozocin-induced diabetic mice and exposed to pulsed electromagnetic fields. Percentage necrosis, oxygen tension, and vascularity were determined. Pulsed electromagnetic fields accelerated wound closure in diabetic and normal mice. Cell proliferation and CD31 density were significantly increased in pulsed electromagnetic field-treated groups. Cultured medium from human umbilical vein endothelial cells in pulsed electromagnetic fields exhibited a three-fold increase in FGF-2, which facilitated healing when applied to wounds. Skin on diabetic mice exposed to pulsed electromagnetic fields did not exhibit tissue necrosis and demonstrated oxygen tensions and vascularity comparable to those in normal animals. This study demonstrates that pulsed electromagnetic fields are able to accelerate wound healing under diabetic and normal conditions by up-regulation of FGF-2-mediated angiogenesis. They also prevented tissue necrosis in response to a standardized ischemic insult, suggesting that noninvasive angiogenic stimulation by pulsed electromagnetic fields may be useful to prevent ulcer formation, necrosis, and amputation in diabetic patients.