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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3876_Библиотеки_им_академика_М_И_Перельмана
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• We recommend that patients with DFU have pedal perfusion assessed by
ABI, ankle and pedal Doppler arterial waveforms, and either toe systolic
pressure or transcutaneous oxygen pressure (TcPO2) annually (Grade 1B).
• In patients with DFU who have PAD, we recommend revascularization by
either surgical bypass or endovascular therapy (Grade 1B). Technical and
implementation remarks)
– Prediction of patients most likely to require and to benet from revascular-
ization can be based on the Society for Vascular Surgery (SVS) Wound,
Ischemia, and foot Infection (WIfI) lower extremity threatened limb
classication.
– A combination of clinical judgment and careful interpretation of objective
assessments of perfusion along with consideration of the wound and infection extent is required to select patients appropriately for
revascularization.
– In functional patients with long-segment occlusive disease and a good
autologous conduit, bypass is likely to be preferable.
– In the setting of tissue loss and diabetes, prosthetic bypass is inferior to
bypass with vein conduit.
– The choice of intervention depends on the degree of ischemia, the extent of
arterial disease, the extent of the wound, the presence or absence of infection, and the available expertise.
17 The Diabetic Foot
17.1.2 International Working Group ontheDiabetic
Foot (IWGDF)
17.1.2.1 Recommendations ontheDiagnosis andManagement ofFoot
Infections inPersons withDiabetes [2]
Quality of evidence is rated as ‘high’, ‘moderate’ or ‘low’. Strength of each recommendation is assessed as ‘strong’ or ‘weak’.
• Classication/diagnosis
– Diabetic foot infection must be diagnosed clinically, based on the presence of
local or systemic signs or symptoms of inammation (strong; low).
– Assess the severity of any DFI using the Infectious Diseases Society of
America/International Working Group on the Diabetic Foot classication
scheme (strong; moderate).
• Osteomyelitis
– For an infected open wound, perform a probe-to-bone test; in a patient at low
risk for osteomyelitis, a negative test largely rules out the diagnosis, while in
a high-risk patient, a positive test is largely diagnostic (strong; high).
17.1 Guidelines
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– Markedly elevated serum inammatory markers, especially erythrocyte sedi-
mentation rate, are suggestive of osteomyelitis in suspected cases (weak;
moderate).
– A denite diagnosis of bone infection usually requires positive results on
microbiological (and, optimally, histological) examinations of an aseptically
obtained bone sample, but this is usually required only when the diagnosis is
in doubt or determining the causative pathogen’s antibiotic susceptibility is
crucial (strong; moderate).
– A probable diagnosis of bone infection is reasonable if there are positive
results on a combination of diagnostic tests, such as probe-to-bone, serum
inammatory markers, plain X-ray, magnetic resonance imaging (MRI) or
radionuclide scanning (strong; weak).
– Avoid using results of soft tissue or sinus tract specimens for selecting antibi-
otic therapy for osteomyelitis as they do not accurately reect bone culture
results (strong; moderate).
– Obtain plain X-rays of the foot in all cases of non-supercial diabetic foot
infection (strong; low).
– Use MRI when an advanced imaging test is needed for diagnosing diabetic
foot osteomyelitis (strong; moderate).
– When MRI is not available or contraindicated, consider a white blood cell-
labelled radionuclide scan, or possibly single-photon emission computed
tomography (CT) and CT (SPECT/CT) or uorine-18-uorodeoxyglucose
positron emission tomography/CT scans (weak; moderate).
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• Assessing severity
– At initial evaluation of any infected foot, obtain vital signs and appropriate
blood tests, debride the wound and probe and assess the depth and extent of
the infection to establish its severity (strong; moderate).
– At initial evaluation, assess arterial perfusion and decide whether and when
further vascular assessment or revascularization is needed (strong; low).
• Microbiological considerations
– Obtain cultures, preferably of a tissue specimen rather than a swab, of infected
wounds to determine the causative microorganisms and their antibiotic sensitivity (strong; high).
– Do not obtain repeat cultures unless the patient is not clinically responding to
treatment, or occasionally for infection control surveillance of resistant pathogens (strong; low).
– Send collected specimens to the microbiology laboratory promptly, in sterile
transport containers, accompanied by clinical information on the type of specimen and location of the wound (strong; low).
• Surgical treatment
– Consult a surgical specialist in selected cases of moderate, and all cases of
severe diabetic foot infection (weak; low).
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– Perform urgent surgical interventions in cases of deep abscesses, compart-
ment syndrome and virtually all necrotizing soft tissue infections (strong; low).
– Consider surgical intervention in cases of osteomyelitis accompanied by
spreading soft tissue infection, destroyed soft tissue envelope, progressive
bone destruction on X-ray or bone protruding through the ulcer (strong; low).
• Antimicrobial therapy
– While virtually all clinically infected diabetic foot wounds require antimicro-
bial therapy, do not treat clinically uninfected wounds with antimicrobial
therapy (strong; low).
– Select specic antibiotic agents for treatment based on the likely or proven
causative pathogens, their antibiotic susceptibilities, the clinical severity of
the infection, evidence of efcacy of the agent for diabetic foot infection and
costs (strong; moderate).
– A course of antibiotic therapy of 1–2weeks is usually adequate for most mild
and moderate infections (strong; high).
– Administer parenteral therapy initially for most severe infections and some
moderate infections, with a switch to oral therapy when the infection is
responding (strong; low).
– Do not select a specic type of dressing for a diabetic foot infection with the
aim of preventing an infection or improving its outcome (strong; high).
– For diabetic foot osteomyelitis, we recommend 6weeks of antibiotic therapy
for patients who do not undergo resection of infected bone and no more than
a week of antibiotic treatment if all infected bone is resected (strong;
moderate).
– We suggest not using any adjunctive treatments for diabetic foot infection
(weak; low).
– When treating a diabetic foot infection, assess for use of traditional remedies
and previous antibiotic use and consider local bacterial pathogens and their
susceptibility prole (strong; low).
17 The Diabetic Foot
17.1.3 International Working Group ontheDiabetic
Foot (IWGDF)
17.1.3.1 Guidance onUse ofInterventions toEnhance theHealing
ofChronic Ulcers oftheFoot inDiabetes [3]
• Clean ulcers regularly with clean water or saline, debride them when possible in
order to remove debris from the wound surface and dress them with a sterile,
inert dressing in order to control excessive exudate and maintain a warm, moist
environment in order to promote healing (strong; low).
• In general, remove slough, necrotic tissue and surrounding callus with sharp
debridement in preference to other methods, taking relative contraindications
such as severe ischemia into account (strong; low).
17.1 Guidelines
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• Select dressing principally on the basis of exudate control, comfort and cost
(strong; low).
• Do not use antimicrobial dressings with the goal of improving wound healing or
preventing secondary infection (strong; moderate).
• Consider the use of systemic hyperbaric oxygen therapy, even though further
blinded and randomized trials are required to conrm its cost-effectiveness, as
well as to identify the population most likely to benet from its use (weak;
moderate).
• Topical negative pressure wound therapy may be considered in post-operative
wounds even though the effectiveness and cost-effectiveness of the approach
remain to be established (weak; moderate).
• Do not select agents reported to improve wound healing by altering the biology
of the wound, including growth factors, bioengineered skin products and gases,
in preference to accepted standards of good quality care (strong; low).
• Do not select agents reported to have an impact on wound healing through altera-
tion of the physical environment, including through the use of electricity, magnetism, ultrasound and shockwaves, in preference to accepted standards of good
quality care (strong; low).
• Do not select systemic treatments reported to improve wound healing, including
drugs and herbal therapies, in preference to accepted standards of good quality
care (strong; low).
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17.1.4 International Working Group ontheDiabetic Foot
(IWGDF 2019 Update) [4, 5]
17.1.4.1 Guidelines onDiagnosis, Prognosis, andManagement
ofPeripheral Artery Disease inPatients withFoot Ulcers
andDiabetes [4]
• Examine the feet of all patients with diabetes annually for the presence of periph-
eral artery disease (PAD), even in the absence of foot ulceration. At a minimum,
this should include taking a relevant history and palpating foot pulses
(strong; low).
• Clinically examine (by relevant history and palpation of foot pulses) all patients
with diabetes and foot ulceration for the presence of PAD (strong; low).
• As clinical examination does not reliably exclude PAD in most persons with
diabetes and a foot ulcer, evaluate pedal Doppler arterial waveforms in combination with ankle systolic pressure and systolic ankle brachial index (ABI) or toe
systolic pressure and toe brachial index (TBI) measurement. No single modality
has been shown to be optimal, and there is no denite threshold value above
which PAD can reliably be excluded. However, PAD is a less likely diagnosis in
the presence of ABI, 0.9–1.3; TBI, ≥0.75; and triphasic pedal Doppler waveforms (strong; low).
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17 The Diabetic Foot
• Perform at least one of the following bedside tests in a patient with a diabetic
foot ulcer and PAD, any of which increases the pretest probability of healing by
at least 25%: a skin perfusion pressure of ≥40 mmHg, a toe pressure of
≥30 mmHg, or a transcutaneous oxygen pressure (TcPO2) of ≥25 mmHg
(strong; moderate).
• Use the Wound, Ischaemia, and foot Infection (WIfI) classication system as a
means to stratify amputation risk and revascularization benet in a patient with a
diabetic foot ulcer and PAD (strong; moderate).
• Always consider urgent vascular imaging, and revascularization, in a patient
with a diabetic foot ulcer and an ankle pressure of <50mmHg, ABI of <0.5, a toe
pressure of <30 mmHg, or a TcPO2 of <25mmHg (strong; low).
• Always consider vascular imaging in patients with a diabetic foot ulcer, irrespec-
tive of the results of bedside tests, when the ulcer is not healing within 4–6 weeks
despite good standard of care (strong; low).
• Always consider revascularization in a patient with a diabetic foot ulcer and
PAD, irrespective of the results of bedside tests, when the ulcer is not healing
within 4–6 weeks despite optimal management (strong; low).
• Do not assume diabetic microangiopathy, when present, is the cause of poor
healing in patients with a diabetic foot ulcer; therefore, always consider other
possibilities for poor healing (strong; low).
• Use any of the following modalities to obtain anatomical information when con-
sidering revascularizing a patient’s lower extremity: colour duplex ultrasound,
computed tomographic angiography, magnetic resonance angiography, or intraarterial digital subtraction angiography. Evaluate the entire lower extremity arterial circulation with detailed visualization of below-the-knee and pedal arteries,
in an anteroposterior and lateral plane (strong; low).
• When performing revascularization in a patient with a diabetic foot ulcer, aim to
restore direct blood ow to at least one of the foot arteries, preferably the artery
that supplies the anatomical region of the ulcer. After the procedure, evaluate its
effectiveness with an objective measurement of perfusion (strong; low).
• As evidence is inadequate to establish whether an endovascular, open, or hybrid
revascularization technique is superior, make decisions based on individual factors, such as morphological distribution of PAD, availability of autogenous vein,
patient co-morbidities, and local expertise (strong; low).
• Any centre treating patients with a diabetic foot ulcer should have expertise in,
and rapid access to facilities necessary to diagnose and treat, PAD, including
both endovascular techniques and bypass surgery (strong; low).
• Ensure that after a revascularization procedure in a patient with a diabetic foot
ulcer, the patient is treated by a multidisciplinary team as part of a comprehensive care plan (strong; low).
• Urgently assess and treat patients with signs or symptoms of PAD and a diabetic
foot infection, as they are at particularly high risk for major limb amputation
(strong; moderate).
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• Avoid revascularization in patients in whom, from the patient’s perspective, the
risk-benet ratio for the probability of success of the procedure is unfavourable
(strong; low).
• Provide intensive cardiovascular risk management for any patient with diabetes
and an ischaemic foot ulcer, including support for cessation of smoking, treatment of hypertension, control of glycaemia, and treatment with a statin drug as
well as low-dose clopidogrel or aspirin (strong; low).
17.1.4.2 Guidelines onOfoading Foot Ulcers inPersons
withDiabetes [5]
1. (a) In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer,
use a nonremovable knee-high ofoading device with an appropriate foot-device
interface as the rst choice of ofoading treatment to promote healing of the
ulcer (strong; high).
(b) When using a nonremovable knee-high ofoading device to heal a neuropathic plantar forefoot or midfoot ulcer in a person with diabetes, use either a
total contact cast or nonremovable knee-high walker, with the choice dependent
on the resources available, technician skills, patient preferences, and extent of
foot deformity present (strong; moderate).
2. In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer for
whom a nonremovable knee-high ofoading device is contraindicated or not tolerated, consider using a removable knee-high ofoading device with an appropriate foot-device interface as the second choice of ofoading treatment to
promote healing of the ulcer. Additionally, encourage the patient to wear the
device at all times (weak; low).
3. In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer for
whom a knee-high ofoading device is contraindicated or not tolerated, use a
removable ankle-high ofoading device as the third choice of ofoading treatment to promote healing of the ulcer. Additionally, encourage the patient to wear
the device at all times (strong; low).
4. (a) In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer,
do not use, and instruct the patient not to use, conventional or standard therapeutic footwear as ofoading treatment to promote healing of the ulcer, unless none
of the abovementioned ofoading devices is available (strong; moderate).
(b) In that case, consider using felted foam in combination with appropriately
tting conventional or standard therapeutic footwear as the fourth choice of
ofoading treatment to promote healing of the ulcer (weak; low).
5. In a person with diabetes and a neuropathic plantar metatarsal head ulcer, consider using Achilles tendon lengthening, metatarsal head resection(s), or joint
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arthroplasty to promote healing of the ulcer, if non-surgical ofoading treatment
fails (weak; low).
6. In a person with diabetes and a neuropathic plantar or apex digital ulcer, consider
using digital exor tenotomy to promote healing of the ulcer, if non-surgical
ofoading treatment fails (weak; low).
7. (a) In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer
with either mild infection or mild ischaemia, consider using a nonremovable
knee-high ofoading device to promote healing of the ulcer (weak; low).
(b) In a person with diabetes and a neuropathic plantar forefoot or midfoot
ulcer with both mild infection and mild ischaemia or with either moderate infection or moderate ischaemia, consider using a removable knee-high ofoading
device to promote healing of the ulcer (weak; low).
(c) In a person with diabetes and a neuropathic plantar forefoot or midfoot
ulcer with both moderate infection and moderate ischaemia or with either severe
infection or severe ischaemia, primarily address the infection and/or ischaemia,
and consider using a removable ofoading intervention based on the patient’s
functioning, ambulatory status, and activity level, to promote healing of the ulcer
(weak; low).
8. In a person with diabetes and a neuropathic plantar heel ulcer, consider using a
knee-high ofoading device or other ofoading intervention that effectively
reduces plantar pressure on the heel and is tolerated by the patient, to promote
healing of the ulcer (weak; low).
9. In a person with diabetes and a nonplantar foot ulcer, use a removable ankle-high
ofoading device, footwear modications, toe spacers, or orthoses, depending
on the type and location of the foot ulcer, to promote healing of the ulcer
(strong; low).
17 The Diabetic Foot
17.1.5 Guidelines ontheClassication ofFoot Ulcers
inPeople withDiabetes (IWGDF 2023 Update) [6]
• In a person with diabetes and a foot ulcer, use the SINBAD system for commu-
nication between healthcare professionals about the characteristics of an ulcer,
and clearly state the presence or absence of each of the composing variables
(Strength of recommendation: Strong; Certainty of evidence: Low)
• In a person with diabetes and a foot ulcer, when re-sources exist in addition to an
appropriate level of expertise and it is considered feasible, consider using the
WIfI system for communication about the characteristics of an ulcer between
healthcare professionals, but with characterization of each of the composing
variables (Conditional; Low)
SINBAD system for grading foot ulcers
17.1 Guidelines
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Category Denition Score
Site
Ischemia
Neuropathy
Bacterial infection
Area ulcer
Depth
Total possible score 0–6
- Forefoot
- Midfoot and hindfoot
- Pedal blood ow intact: at least one palpable pulse
- Clinical evidence of reduced pedal ow
- Protective sensation intact
- Protective sensation lost
- None
- Present
- Ulcer <1cm
- Ulcer ≥1cm
- Ulcer conned to skin and subcutaneous tissue
- Ulcer reaching muscle, tendon or deeper
2
2
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0
1
0
1
0
1
0
1
0
1
0
1
17.1.6 WIfI Classication System
For patients with a threatened lower extremity because of ischemia, wound and
infection, the Society for Vascular Surgery has proposed the threatened limb classication system. The primary purpose of this classication is to provide more precise description of the disease burden to allow accurate outcomes assessments and
comparisons between similar groups of patients and alternative therapies [7]. The
classication system is based simply on grading each of the three major factors
(Wound, Ischemia, and foot Infection [WIfI]). It is based on a scale from 0 to 3,
where 0 represents none, 1 mild, 2 moderate, and 3 severe.
1. Wound Grades
• 0=No ulcer/No gangrene
• 1= Small, shallow ulcer(s) on distal leg or foot; no exposed bone, unless
limited to distal phalanx/No gangrene
• 2=Deeper ulcer with exposed bone, joint or tendon; generally not involving
the heel; shallow heel ulcer, without calcaneal involvement/Gangrenous
changes limited to digits
• 3=Extensive, deep ulcer involving forefoot and/or midfoot; deep, full thick-
ness heel ulcer±calcaneal involvement/Extensive gangrene involving forefoot and/or midfoot; full thickness heel necrosis±calcaneal involvement
2. Ischemia
• 0=ABI≥0.80/Ankle systolic pressure>100mmHg/Tp, TcPO2≥60mmHg
• 1 = ABI 0.6–0.79/Ankle systolic pressure 70–100 mmHg/Tp, TcPO2
40–59mmHg
• 2 = ABI 0.4–0.59/Ankle systolic pressure 50–70 mmHg/Tp, TcPO2
30–39mmHg
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17 The Diabetic Foot
• 3=ABI≤0.39/Ankle systolic pressure<50mmHg/Tp, TcPO2<30mmHg
ABI, Ankle-brachial index; TP, toe pressure; TcPO2, transcutaneous oximetry.
3. Clinical manifestation of infection
• 0=No symptoms or signs of infection
• 1=Local infection involving only the skin and the subcutaneous tissue (with-
out involvement of deeper tissues and without systemic signs)
• 2=Local infection with erythema >2cm, or involving structures deeper than
skin and subcutaneous tissues (e.g., abscess, osteomyelitis, septic arthritis,
fasciitis)
• 3=Local infection (as described above) with the signs of SIRS, as manifested
by two or more of the following:
– Temperature>38° or<36°C
– Heart rate>90beats/min
– Respiratory rate>20breaths/min or PaCO2<32mm Hg
– White blood cell count >12,000 or < 4000 cu/mm or 10% immature
(band) forms
PAC O2, Partial pressure of arterial carbon dioxide; SIRS, systemic inammatory
response syndrome.
Since each of the three categories (wound, ischemia, and foot infection) has four
grades of severity, the system produces a grid with 64 theoretically possible clinical
combinations (WIfI classes).
The available evidence was reviewed by van Reijen etal. [8] regarding the value
of the WIfI classication in patients presenting with CLTI to predict the one-year
major amputation risk and the benet of revascularization. In this systematic review,
12 studies comprising 2669 patients, most of whom underwent endovascular or
open revascularization were included. Overall study quality was moderate. All but
one were retrospective studies, including a variety of subpopulations of patients
with CLTI, such as only haemodialysis dependent, diabetic or non-diabetic patients.
Estimated one year major amputation rates from four studies comprising 569
patients were 0%, 8% (95% CI 3–21%), 11% (95% CI 6–18%) and 38% (95% CI
21–58%), for WIfI stages I-IV, respectively. This review showed that the likelihood
of a major amputation after 1year in patients with CLTI does increase with higher
clinical WIfI stages, especially in stage IV, which is important prognostic information. Similarly, the higher the WIfI stage, the lower AFS and limb salvage rates after
1year. However, sufcient evidence was not found to support the use of the WIfI
classication to predict the benet of revascularization.
17.2 Systematic Reviews andStudies
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17.2 Systematic Reviews andStudies
17.2.1 Classication
A systematic review aimed to gather all the available evidence around the existing
systems that were used to classify foot ulcers in people with diabetes [9]. 28 systems
addressed in 149 studies were found. Overall, the certainty of the evidence for each
classication was low or very low, with 19 (68%) of the classications being
assessed by ≤3 studies. The most frequently validated system was the one from
Meggitt-Wagner, but the articles validating this system focused mainly on the association between the different grades and amputation. Clinical outcomes were not
standardized but included ulcer-free survival, ulcer healing, hospitalisation, limb
amputation, mortality, and cost. Despite the limitations, this systematic review provided sufcient evidence to support recommendations on the use of six particular
systems in specic clinical scenarios.
Meggitt-Wagner classication of foot ulcers
Grade Description
0 Pre-or post-ulcerative site
1 Supercial ulcer
2 Ulcer penetrating to tendon or joint capsule
3 Lesion involving deeper tissues
4 Forefoot gangrene
5 Whole foot gangrene involving more than two thirds of the
foot
17.2.2 Epidemiology andPrognosis
Nascimento de Aquino etal. [10] analyzed the incidence, prevalence, and risk factors associated with diabetic foot in people with type 2 Diabetes Mellitus. The metaanalysis showed that the prevalence of diabetic foot was 14% in a hospital setting
and 5% in a community setting. The overall prevalence and incidence were 9% and
4%, respectively. Signicant risk factors included time of DM (odds ratio [OR]
=1.46, condence interval [CI], 0.36–2.57, P=0.009), smoking (OR=1.46, CI,
1.16–1.85, P<.001), glycated hemoglobin (OR=0.96, CI, 0.50; 1.42, P<.001),
peripheral arterial disease (OR=3.38, CI, 2.07; 5.53, P<.001) and peripheral neuropathy (OR=5.88, CI, 2.39–14.45, P<.001). Multidisciplinary monitoring, educational strategies, periodic foot examination for alterations, and early identication
of risk factors are essential to prevent ulceration and reduce the disease burden.
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