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Surg. 2011;29(2):109–14. https://doi.org/10.1089/
pho.2009.2680; Epub 2011 Jan 9.
28. Leclère FM, Puechguiral IR, Rotteleur G, Thomas
P, Mordon SR. A prospective randomized study of
980nm diode laser-assisted venous ulcer healing on
34 patients. Wound Repair Regen. 2011;19(1):116.
https://doi.org/10.1111/j.1524- 475X.2010.00637.x;
Epub 2010 Oct 19.
29. Taradaj J, Franek A, Blaszczak E, Polak A,
Chmielewska D, Krol P, Dolibog P. Using physical modalities in the treatment of venous leg ulcers:
a 14-year comparative clinical study. Wounds.
2012;24(8):215–26.
30. Kajagar BM, Godhi AS, Pandit A, Khatri S.Efcacy
of low level laser therapy on wound healing in patients
with chronic diabetic foot ulcers—a randomised control trial. Indian J Surg. 2012;74(5):359–63.
31. Moskvin SV, Geynitz AV, Askhadulin EV. Efciency
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32. Vitse J, Bekara F, Byun S, Herlin C, Teot L.A doubleblind, placebo-controlled randomized evaluation of
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Alencar de Oliveira R, Amadei Nicolau R, Araújo
Rezende VE, Loschiavo Arisawa EA. Effects of
low-power light therapy on the tissue repair process
of chronic wounds in diabetic feet. Photomed Laser
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34. Bavaresco T, De Fátima LA.Low-laser light therapy
in venous ulcer healing: a randomized clinical trial.
Rev Bras Enferm. 2021;75(3):e20210396.

Treatment ofChronic Wounds
https://t.me/medicina_free
andUlcers withFocused
andDefocused Shock Waves
RaoululSaggini, RosaGraziaBellomo,
andAndreaSaggini
18
18.1 Introduction
Chronic soft tissue wounds pose a therapeutic
challenge, and the problems arise from a combination of factors, the most important being the
outpatient setting, treatment cost, duration, and
patient/nursing staff compliance with dressing
systems. The outpatient problem cannot be
solved by the physician alone, but it is a product
of wound chronicity and the resulting extraneous
decision-making factors (reduction of hospital
beds, cost of hospitalization, and insurance coverage policies) that lead to patient discharge after
primary treatment attempts. The focus in managing chronic soft tissue wounds is directed toward
reducing costs and duration, as well as simplifying treatment modalities in the outpatient/extramural setting.
R. u. Saggini (*)
Physical and Rehabilitation Medicine, Ecampus
University, Novedrate, Italy
R. G. Bellomo
Physical and Rehabilitation Medicine, Carlo Bò
University, Urbino, Italy
A. Saggini
Dermatology and Pathological Anatomy,
Friburg, Germany
e-mail: raoul.saggini@eunicampus.it
18.2 Shock Waves
Shock waves are mechanical and repetitive stimuli with high energy that are similar to acoustic
waves, capable of stimulating the biological healing of both acute and chronic pathological tissues
[1]. They are impulsive phenomena with a rapid
rise time and a slightly slower descent, followed
by a nal readaptation around the zero line. They
are transient disturbances that propagate in three
dimensions and are characterized by an advancing front that falls into the category of acoustic
waves. The treated tissue is subjected to repeated
high-intensity pressure stimuli [2]. Shock waves
are acoustic waves that possess properties such as
high pressure exceeding 400 megapascals, rapid
rise time almost vertical, below 10 billionths of a
second, and a short life span below 10 ms with a
characteristic rise and negative descent phase that
is typical for all shock wave generators but varies
among different types of generators [3]. Today,
through advances in basic sciences, we know the
real effect of shock waves on living tissues, and
these effects can be achieved with signicantly
lower energy treatment protocols that are better
tolerated and free of signicant side effects, making them applicable in the treatment of ulcers. All
this ts into the mechanism of regenerative
medicine.
The treatment consists of a succession of
shock waves at regular intervals, but there are
also interferences between successive stimula-
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2023
M. Maruccia et al. (eds.), Pearls and Pitfalls in Skin Ulcer Management,
https://doi.org/10.1007/978-3-031-45453-0_18
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R. u. Saggini et al.
tions [4]. It should be noted that shock waves
propagating in a medium at approximately the
speed of sound have later stimuli that tend to
have a slightly higher speed than the rst stimuli,
resulting in a partial summation of effects.
Additionally, phenomena such as reection,
refraction, and diffraction should be considered,
as they determine mutual interference between
the emissions of stimuli at different times. The
physical or biological reactions that occur are of
three types. The rst reaction has direct effects on
the interface, meaning that when the wave front
passes between two media with a signicant density difference, a high amount of energy is
released [5]. The second reaction occurs through
the formation of vapor bubbles in the liquids
crossed by shock waves. Inside the bubbles, there
is a negative pressure that tends to induce collapse when new shock waves reach them. The
bubbles then deform in an ellipsoidal direction
until they implode, resulting in a jet of water traveling at a speed over 23 times the speed of sound
[6]. The third reaction is a physical-biological
reaction, specically mechanotransduction,
where shock waves passing through the tissue
cause high-pressure gradients of approximately
160 megapascals per square millimeter. Pressure,
tension, and shear forces stimulate cell irritation
due to the mechanical deformation of the cytoskeleton [7]. Thus, various signicant biochemical processes are triggered, leading to intrinsic
healing of the affected cellular structures [8].
18.3 Aspects ofTechnology
There are three technologies for the production
of focused and defocused waves that, in different
ways, determine a physical stimulation that is
completely overlapping among them. The electrohydraulic generator consists of a water-lled
ellipsoid with a rst focal point called F1, consisting of two electrodes placed 1mm apart. The
high voltage generated between these two electrodes creates a vapor bubble that expands inside
the ellipsoid, causing a pressure wave with the
characteristics of a shock wave. This wave is
reected by the internal walls of the ellipsoid to
an external point called F2, which represents the
treatment area. The electrohydraulic technology
generates a strong potential difference with the
discharge of a spark and is capable of creating a
gas bubble that expands extremely rapidly in a
spherocentric manner, with a specic focal point
formation. It does not rely on a membrane that
needs to be moved, there is no inertia to overcome, and it is very fast and more manageable in
its focusing. It retains less energy near zero while
waiting for another shock wave of the same type
and power to be generated. In this case, it is not a
markedly negative wave, which is a disruptive
aspect of the signal related to the specic characteristics of the electromagnetic generator and the
membrane used [9].
The electromagnetic generator, on the other
hand, can be found in either a at coil or cylindrical coil variant, but its operation is identical. The
coil is coated with a metal membrane that, when
current passes through it, expands and generates
the shock wave, which is then focused outside the
device due to reection. The electromagnetic
technology works by delivering a signal to the
loudspeaker, which magnetically excites the coil
in a magnetic eld, causing it to move back and
forth, pushing the loudspeaker’s membrane. This
process generates the shock wave. In this case,
the membrane is cylindrical and placed around
the coil, which oscillates back and forth to transmit the vibration to the parabola that concentrates
the energy into a focal point.
The piezoelectric generator instead exploits
the ability of piezoelectric crystals to contract or
expand when subjected to a strong electric voltage. In this case, a large number of crystals are
placed on the inner surface of a semispherical
shell, and the individual stimulations of the crystals are all directed toward the focal point, where
the stimuli are summed up and the shock wave is
generated. The piezoelectric technology has an
emitter with a concavity where thousands of
piezoelectric crystals are placed and where the
electric current is generated in the quartz. The
quartz crystals oscillate very rapidly and form
this pressure wave, which is not a true shock
wave. However, as the pressure waves are focused
by the bell, as they approach the focal point, their

18 Treatment ofChronic Wounds andUlcers withFocused andDefocused Shock Waves
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177
peaks come closer together. When the peaks
coincide at a point called the focal point, that is
where the shock wave is formed. This results in
an extremely small focal point.
The essential parameters for establishing the
characteristics to be administered for each session of shock wave treatment are (1) the ux density measured in millijoules per square millimeter,
representing the estimation of the energy or force
delivered per pulse; (2) the number of pulses
administered, which depends on the pathology
being treated and the size of the anatomical structure; and (3) the frequency, i.e., the number of
pulses per second, which can be adjusted to different frequencies ranging from a minimum of 1
Hertz to a maximum of 8 Hertz. It should be
noted that there are focal-type generators that can
generate a defocused shock wave, which is particularly useful in the eld of wound care and
skin treatment [10, 11].
18.4 The Biological Stimulus
oftheShock Wave
In this regard, it should be noted that the concept
of mechanotransduction needs to be introduced,
which correlates with the fact that mechanical
stimuli can induce biological reactions in target
cells, similar to the active ingredient in a drug.
This is a pathway to which many types of cells
are sensitive: This mechanical stimulation is perceived by the extracellular environment and
translated into biochemical responses capable of
inuencing many cellular functions such as
migration, proliferation, differentiation, and
apoptosis. Many cellular structures are involved
in these phenomena, including stretch-activated
ion channels, integrins and cadherins, growth
factor receptors, known as gap junctions, and
endocellular organelles. The cell membrane also
undergoes the effect of the shock wave at specic
therapeutic dosages, resulting in increased
permeability.
The neovascularization effect of shock wave
treatment is also of interest, as it induces an early
effect known as transient vasoplegia, due to a
sympathicoplegic effect directly induced in the
pre-capillary sphincters. This is followed by a
subsequent delayed effect involving the endothelial cell-stimulating angiogenesis factor (ESAF),
a low-molecular-weight peptide capable of activating collagenase, which acts on the basement
membrane of the vessel wall. This creates continuous solutions on the basement membrane
itself and triggers the migration of endothelial
cells, directly initiating a process of neoangiogenesis. These signicant effects can be correlated with the results obtained in the stimulation
of skin affected by diabetic vascular ulcers,
chronic pressure ulcers, brosis, and retracting
scars. The main targets of shock waves appear to
be the membranes, leading to increased permeability of cell membranes and walls, making it a
potential additional treatment in infected conditions. It has been discovered that high-energy
shock waves possess antibacterial activity, which
can have clinical relevance in reducing bacterial
growth [12].
Methods developed in recent decades have
shown a signicant reduction in wound size and
accelerated healing, but also a lack of complete
epithelialization. Extracorporeal shock wave
therapy (ESWT) has been shown to promote
wound closure and complete epithelialization
through neovascularization, mainly driven by
endothelial cell proliferation and vasculogenesis.
When the wound begins to heal, cells proliferate
and build granulation tissue that is highly permeated by capillaries. Subsequently, during epithelialization, scar tissue is formed. Shock waves
have been shown to accelerate granulation and
reepithelialization while reducing scar formation.
Shock waves increase the overall blood circulation of the affected areas and stimulate cutaneous
and muscular microcirculation. They recruit
endothelial progenitor cells and enhance the
expression of angiogenic factors such as VEGF
or TGF-beta, as well as nitric oxide, a potent
vasodilator. Shock waves strongly promote tissue
regeneration cascades, particularly the activation
of TGF-beta1 and type 1 and type 3 collagens,
which are major factors involved in tissue repair
processes. They also stimulate broblast proliferation and the metabolism of the extracellular
matrix [13].

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After demonstrating the dose-effect relationship of shock waves, it is suggested that
for invitro cell treatment, optimal parameters
are an intensity between 0.10 and 0.13 mj/
mm2 and a number of pulses between 200 and
300. For chronic ulcers invivo, it is suggested
to use a number of pulses between 600 and
1000, repeated five times at a 7-day interval,
with an intensity between 0.10 and 0.13 mj/
mm2.
Infection of chronic wounds is a significant
challenge during wound treatment, as microbial colonization sustains inflammation and
impairs the healing process. Shock waves have
been reported to have a bactericidal effect and
can reduce bacterial load in the affected
tissue.
Chronic wound infection poses a signicant
challenge during wound treatment, as microbial
colonization sustains inammation and compromises the healing process. It has been reported
that shock waves have a bactericidal effect and
are capable of reducing the bacterial load in the
affected tissue. Another positive benecial
aspect of shock waves is that they increase the
number of microvessels and improve the systemic administration of antibiotics to the
infected wound.
The negative effects of chronic inammation
are suppressed with shock wave treatment alone,
leading to improved wound healing with better
tissue perfusion and increased blood vessel formation. Difcult-to-heal and chronic wounds
show signicant improvement after treatment,
with a low recurrence rate.
The treatment is clinically effective, noninvasive, and well-tolerated by patients, and it
does not require anesthesia. It is cost-effective
and easily applicable in an outpatient setting.
In summary, the use of low-energy focused
and defocused extracorporeal shock wave therapy (ESWT) on a large patient population with
acute and chronic soft tissue wounds has demonstrated its suitability in achieving complete closure of the majority of wounds (see illustrations
in Figs. 18.1, 18.2, 18.3, 18.4, 18.5, 18.6, 18.7
and 18.8).
R. u. Saggini et al.
Fig. 18.1 Patient 55 year old with chronic cutaneous
ulcers on the Achilles tendon after post-surgical infection.
Before treatment VAS=5
Fig. 18.2 After ve treatments with 1000 pulses at 0.13
mj/mm2 ESWT VAS=2
Fig. 18.3 Patient 58 year old with pain related to chronic
vascular arterial ulcer on lateral malleolus. Before treatment VAS=6

18 Treatment ofChronic Wounds andUlcers withFocused andDefocused Shock Waves
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179
Fig. 18.4 After ve treatments with 1000 pulses at 0.12
mj/mm2 ESWT VAS=2
Fig. 18.5 Patient 70 year old with pain related to chronic
cutaneous ulcer on Achilles tendon. Before treatment
VAS=5
Fig. 18.6 After ve treatments with 1000 pulses at 0.12
mj/mm2 ESWT VAS=0
Fig. 18.7 Patient 62 year old with chronic cutaneous
ulcers related to venous insufciency. Before treatment
VAS=7
Fig. 18.8 After ve treatments with 1000 pulses at 0.12
mj/mm2 ESWT VAS=3
References
1. Saggini R, etal. Extracorporeal shock wave therapy:
an emerging treatment modality for retracting scars of
the hands. Ultrasound Med Biol. 2015;42:185. https://
doi.org/10.1016/j.ultrasmedbio.2015.07.028.
2. Omar MT, Gwada RF, Shaheen AA, Saggini
R. Extracorporeal shockwave therapy for the treatment of chronic wound of lower extremity: current perspective and systematic review. Int Wound
J. 2017;14(6):898–908. https://doi.org/10.1111/
iwj.12723; Epub 2017 Feb 15. Review.
3. Saggini R, Di Stefano A, Saggini A, Bellomo
RG. Clinical application of shock wave therapy in
musculoskeletal disorders: part II related to myofascial and nerve apparatus. J Biol Regul Homeost
Agents. 2015;29(4):771–85.

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R. u. Saggini et al.
4. Larking AM, Duport S, Clinton M, Hardy M, Andrews
K.Randomized control of extracorporeal shock wave
therapy versus placebo for chronic decubitus ulceration. Clin Rehabil. 2010;24:222–9.
5. Wang C-J, et al. Extracorporeal shockwave treatment for chronic diabetic foot ulcers. J Surg Res.
2009;152:96–103.
6. Dumfarth J, et al. Prophylactic low-energy shock
wave therapy improves wound healing after vein
harvesting for coronary artery bypass graft surgery:
a prospective, randomized trial. Ann Thorac Surg.
2008;86:1909–13.
7. Wolff KS, et al. The inuence of comorbidities and
etiologies on the success of extracorporeal shock
wave therapy for chronic soft tissue wounds: midterm
results. Ultrasound Med Biol. 2011;37:1111–9.
8. Ottomann C, et al. Prospective randomized phase Il
trial of accelerated reepithelialization of supercial
second-degree burn wounds using extracorporeal
shock wave therapy. Ann Surg. 2012;255:23–9.
9. Arno A, et al. Extracorporeal shock waves, a new
non-surgical method to treat severe burns. Burns.
2010;36:844–9.
10. Wang C-J, Ko J-Y, Kuo Y-R, Yang Y-J. Molecular
changes in diabetic foot ulcers. Diabetes Res Clin
Pract. 2011;94:105–10.
11. Leal C et al. Shock wave medicine and leprosy: the
ultimate challenge for skin regeneration by mechanotransduction. Abstract ISMST congress milan. 2014.
12. Saggini R, Bellomo RG, Valentina P, Figus A,
Troccola A, Saggini A, Scuderi N. La terapia con
ESWT a specica focalizzazione nella gestione riabilitativa delle ferite difcili. Eur J Phys Rehabil Med.
2009;45(S):1–3; ISSN: 1973-9087.
13. Saggini R, Figus A, Troccola A, Coco V, Saggini A,
Scuderi N. Extracorporeal shock wave therapy for
management of chronic ulcers in the lower extremities. Ultrasound Med Biol. 2008;34(8):1261–71;
ISSN: 0301-5629.

Hydrosurgery inWound Care
https://t.me/medicina_free
FerdinandoCampitiello
19
The concept of water-jet debridement (hydrosurgery) is a fundamental evolution of traditional
wound cleansing, used for ages on acute wounds
and, more recently, on chronic ones.
Hydrosurgery consists of tissue removal
through a water jet used as a dissection tool to
complete the procedure, thanks to which the surgeon is able to aim precisely at the damaged
necrotic tissues, sparing the healthy ones. This
modality represents a better alternative for procedures that involve soft-tissue debridement.
The effect produced is a consequence of water
irrigation, which physically removes foreign
bodies, debris, and other non-anchored material
from the wound. The more rapid and intense irrigation, the more intense the energy transferred to
the tissues and, as a consequence, the larger the
debridement.
Various technologies have been developed in
this eld, and many devices have been produced.
Some have a milder effect, and others are so powerful that they can be compared to some surgical
instruments [1]. Less aggressive options can be
used to remove necrotic tissue, slough, biolm,
F. Campitiello (*)
Department of Advanced Medical and Surgical
Sciences, University of Campania Luigi Vanvitelli,
Naples, Campania, Italy
e-mail: ferdinando.campitiello@unicampania.it
and other material without a stable structure, with
weak consistency and can be easily removed. The
most powerful options, especially those that use
the “Venturi effect,” are able to precisely disentangle brotic and compact tissues and may
sometimes also be used on bony structures,
according to the rapidity and intensity of the jet
going through the tip of the tool [2]. The precision and versatility of this type of device are so
exible that they allow application in different
settings and conditions, ranging from venous
ulcers to post-surgical diabetic wounds. The
angled tip of the instrument allows to perform
debridement in narrow spaces and pockets where
debridement through scissors or blade can be
challenging [3].
Hydro-jet debridement signicantly reduces
operative time when compared to traditional
methods. Moreover, the quality of debridement is
incredibly high. Chronic cutaneous lesions may
require more than one session of traditional
debridement to obtain an acceptable wound bed.
Through hydrosurgery, instead, a single debridement session is often sufcient to reach an optimal wound bed [4] signicantly reducing healing
time. Another interesting aspect of this technology is the possibility to combine antiseptic solutions to maximize antimicrobial action, which is
fundamental during debridement procedures. It is
possible to combine hydrosurgery with superoxidized solutions or solutions containing polyhexanide (PHMB): Both have a neutral pH, are
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2023
M. Maruccia et al. (eds.), Pearls and Pitfalls in Skin Ulcer Management,
https://doi.org/10.1007/978-3-031-45453-0_19
181

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F. Campitiello
non-toxic for tissues, and perform against all
types of infected materials. In particular, hydrosurgery devices can act as physical and biological
debriding tools [5]. The only possible limitation
of this technology is that it can be painful for the
patient; therefore, it should be restricted to cases
in which optimal pain management is available,
for example, through local anesthesia [6].
Another issue is the assumption that the
water jet might spread bacteria, due to the formation of aerosol during use. This could contribute to contamination of the surgical site [7].
Although questionable, this raises awareness on
the importance of adequate staff training.
Physicians in charge should not only be properly trained, but also have a support system that
includes regular control of incidence of nosocomial infections. It is possible to avoid air contamination by using dedicated cuffs or protection
devices capable of reducing aerosol diffusion.
Cost-effectiveness and costs of the equipment
for hydrosurgery vary according to the different
technologies, but are generally higher than those
of other solutions, especially due to the cost of
single-use materials. On the other side, the
advantages of being a rapid, precise, and effective technique make hydrosurgery so appalling
and suitable for complex wound that need to be
debrided, possibly in a single session under
local anesthesia. Therefore, indication represents the main point concerning the cost-tobenet ratio: When used correctly, hydrosurgery
is considered cost-effective thanks to the reduction in hospital management costs and, in some
cases, in hospital stay [7].
References
1. Brown LL, Shelton HT, Bornside GH, Cohn I Jr.
Evaluation of wound irrigation by pulsatile jet and
conventional methods. Ann Surg. 1978;187:170–3.
2. Granick MS, Tenenhaus M, Knox KR, Ulm
JP. Comparison of wound irrigation and tangential
hydrodissection in bacterial clearance of contaminated
wounds: results of a randomized, controlled clinical
study. Ostomy Wound Manage. 2007;53(4):64–70.
3. Caputo WJ, Beggs DJ, DeFede JL, etal. A prospective randomised controlled clinical trial comparing
hydrosurgery debridement with conventional surgical
debridement in lower extremity ulcers. Int Wound J.
2008;5:288–94.
4. Yuan M, Yin M, Zhang L, Feng J, Zhu J, Zhou Z,
Shu B, Zhou F, Zhang F, Yin H, Wang X, Qi S, Wu
J.Selective debridement of burn wounds using hydrosurgery system. Int Wound J. 2020;17(2):300–9.
https://doi.org/10.1111/iwj.13270; Epub 2019 Nov
29.
5. Draeger RW, Dahners LE.Traumatic wound debridement: a comparison of irrigation methods. J Orthop
Trauma. 2006;20:83–8.
6. Gravante G, Delogu D, Esposito G, Montone
A.Versajet hydrosurgery versus classic escharectomy
for burn débridment: a prospective randomized trial. J
Burn Care Res. 2007;28:720–4.
7. Bowling FL, Stickings DS, Edwards-Jones V, et al.
Hydro debridement of wounds: effectiveness in
reducing wound bacterial contamination and potential for air bacterial contamination. J Foot Ankle Res.
2009;8:13.

Ultrasound inWound Care
https://t.me/medicina_free
AlessandroScalise, OrtensiaPirro,
CesareFoggetti, MarinaPierangeli,
MatteoTorresetti,
andGiovanniMariaDi Benedetto
20
20.1 Introduction
The use of ultrasound for medical applications,
including diagnostics, surgery, and therapy, has
been investigated for decades. It is traditionally
widely used in imaging medicine for the purpose
of medical diagnosis. In 1927, it was discovered
that ultrasound produces lasting changes in biological systems, and this represents the starting
point for the application of ultrasound in the therapeutical eld.
Initially, all the attention was focused on the
thermal effects of ultrasound, mainly to selectively raise the temperature of particular tissues;
recently, it shifted to its non-thermal effects,
which led to a variety of therapeutical applications, such as angiogenesis, bone healing, soft
tissue regeneration, inammation modulation,
physiotherapy, and gene therapy.
The biological effects induced by ultrasound
are various and depend on the exposure levels
used. At low levels, benecial and reversible cellular effects may be produced, whereas at high
intensities instantaneous cell death is sought.
Therapeutical ultrasound can be broadly divided
into “low-power” and “high-power” applications
that cause, respectively, reversible and nonreversible effects on target tissues. The “lowpower” group effects include tissue healing,
angiogenesis, bone healing, inammation modulation, physiotherapy, and gene therapy, whereas
the therapies based on “high-power” ultrasound
in medicine known as high-intensity-focused
ultrasound (HIFU) are used for oncological purposes and lithotripsy.
In this chapter, we will focus on the low-power
group and mainly on the use of this type of ultrasound in the treatment of difcult wounds also
evaluate the effects that this therapy generates on
tissues, on the inammatory process, and on
wound healing. Although numerous benets of
ultrasound therapy have been clinically conrmed, much remains to be discovered about the
mechanism of action of this therapy.
A. Scalise (*) · O. Pirro · C. Foggetti · M. Pierangeli
· M. Torresetti · G. M. Di Benedetto
Medical School, Marche Polytechnique University,
Ancona, Italy
e-mail: alessandro.scalise@ospedaliriuniti.marche.it;
marina.pierangeli@ospedaliriuniti.marche.it;
matteo.torresetti@ospedaliriuniti.marche.it;
giovanni.dibenedetto@ospedaliriuniti.marche.it
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2023
M. Maruccia et al. (eds.), Pearls and Pitfalls in Skin Ulcer Management,
https://doi.org/10.1007/978-3-031-45453-0_20
20.2 Device Characteristics
The ultrasound machine (Fig.20.1) is a medical
device composed of:
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