Prevention and Management of Diabetic Foot Disease 2023 Update

Publication Date: May 13, 2023

Prevention

Screen a person with diabetes at very low risk of foot ulceration (IWGDF risk 0) annually for signs or symptoms of peripheral neuropathy and peripheral artery disease, to determine if the person is at increased risk for foot ulceration, using the IWGDF risk stratification system. (S, H)
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If a person with diabetes has loss of protective sensation or peripheral artery disease, extend the screening using clinical history and further foot examinations to assess for
  • a history of foot ulceration or lower-extremity amputation;
  • diagnosis of end-stage renal disease;
  • presence or progression of foot deformity;
  • limited foot and ankle joint mobility;
  • excess callus;
  • and any pre-ulcerative lesion or ulcer on the foot, to determine their risk for foot ulceration using the IWGDF risk stratification system and to inform treatment. Repeat this screening once every 6-12 months for those classified as IWGDF risk 1, once every 3-6 months for IWGDF risk 2, and once every 1-3 months for IWGDF risk 3.
(S, H)
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Educate, and after that encourage and remind a person with diabetes who is at risk of foot ulceration (IWGDF risk 1-3) to protect their feet by not walking barefoot, not walking in socks without shoes, and not walking in thin-soled slippers, whether indoors or outdoors. (S, L)
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Educate, and after that encourage and remind a person with diabetes who is at risk of foot ulceration (IWGDF risk 1-3) to wash their feet daily (with careful drying, particularly between the toes), use emollients to moisturize dry skin, and cut toenails straight across. (S, L)
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Educate, and after that encourage and remind a person with diabetes who is at risk of foot ulceration (IWGDF risk 1-3) to examine their feet daily and with the presence or suspicion of having a (pre-)ulcerative lesion, to rapidly contact an appropriately-trained healthcare professional for further advice. (S, L)
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Provide structured education to a person with diabetes who is at risk of foot ulceration (IWGDF risk 1-3) about appropriate foot self-care for preventing a foot ulcer. (S, L)
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Consider coaching a person with diabetes who is at moderate or high risk of foot ulceration (IWGDF risk 2-3) to self-monitor foot skin temperatures once per day to identify any early signs of foot inflammation and help prevent a first or recurrent plantar foot ulcer. If the temperature difference between corresponding regions of the left and right foot is above a temperature threshold of 2.2 °C (or 4.0 °F) on two consecutive days, coach the patient to reduce ambulatory activity and consult an adequately trained healthcare professional for further diagnosis and treatment. (C, M)
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In a person with diabetes who is at risk of foot ulceration
and with no or limited foot deformity, no pre-ulcerative lesions and no plantar ulcer history (IWGDF risk 1-3), educate to wear footwear that accommodates the shape of the feet and that fits properly. (S, L)
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with a foot deformity that significantly increases pressure or a pre-ulcerative lesion (IWGDF risk 2 or 3), consider prescribing extra-depth shoes, custom-made footwear, custom-made insoles, and/or toe orthoses. (S, L)
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with a healed plantar foot ulcer (IWGDF risk 3), prescribe therapeutic footwear that has a demonstrated plantar pressure relieving effect during walking, to help prevent a recurrent plantar foot ulcer; furthermore, encourage the person to consistently wear this prescribed footwear, both indoors and outdoors. (S, M)
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Provide appropriate treatment for any pre-ulcerative lesion or excess callus on the foot, for ingrown toe nails, and for fungal infections on the foot, to help prevent a foot ulcer in a person with diabetes who is at risk of foot ulceration (IWGDF risk 1-3). (S, VL)
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In a person with diabetes at risk of foot ulceration (IWGDF risk 1-3) and a non-rigid hammertoe with nail changes, excess callus or a pre-ulcerative lesion on the apex or distal part of this toe
consider digital flexor tendon tenotomy for treating these outcomes and to help prevent a first or recurrent foot ulcer (C, M)
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consider prescribing orthotic interventions, such as toe silicone or (semi-)rigid orthotic devices, to help reduce excess callus on the toe. (C, L)
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In a person with diabetes who is at risk of foot ulceration (IWGDF risk 1-3), we suggest not to use a nerve decompression procedure to help prevent a foot ulcer. (C, VL)
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Consider advising and referring a person with diabetes who is at low or moderate risk for foot ulceration (IWGDF risk 1 or 2) to participate in an 8-12-weeks foot-ankle exercise program, preferably under the supervision of an appropriately trained healthcare professional, and to continue performing foot-ankle exercises afterwards, with the aim of reducing risk factors for ulceration. (C, L)
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Consider communicating to a person with diabetes who is at low or moderate risk for foot ulceration (IWGDF risk 1 or 2) that an increase in the level of walking-related weight-bearing daily activity by an extra 1000 steps/day is likely to be safe regarding risk of foot ulceration. Advise this person to wear appropriate footwear when undertaking weight-bearing activities, and to frequently monitor the skin for (pre-)ulcerative lesions. (C, L)
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Provide integrated foot care for a person with diabetes who is at moderate or high risk of foot ulceration (IWGDF risk 2 and 3) to help prevent a first or recurrent foot ulcer. This integrated foot care should include at least professional foot care, adequate footwear and structured education about self-care. Repeat this foot care or re-evaluate the need for it once every one to three months for a person at high risk, and once every three to six months for a person at moderate risk, as necessary. (S, L)
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Table: The IWGDF 2023 Risk Stratification System and corresponding foot screening frequency

Category Ulcer Risk Characteristics Frequency
0 Very Low No LOPS and no signs of PAD Once a year
1 Low LOPS or PAD Once ever 6-12 months
2 Moderate LOPS + PAD, or LOPS + foot deformity or PAD + foot deformity Once every 3-6 months
3 High LOPS or PAD, and one or more of the following: history of a foot ulcer; lower-extremity amputation (minor or major); end-stage renal disease Once every 1--3 months

Foot Ulcer Prevention

If a person with diabetes without a foot ulcer presents at your clinic, there are five key elements that underpin efforts to prevent foot ulcers, as described in the IWGDF Prevention Guideline:
  • Identify the person with an at-risk foot
  • Regularly inspect and examine the feet of a person at-risk for foot ulceration
  • Provide structured education for patients, their family and healthcare professionals
  • Encourage routine wearing of appropriate footwear
  • Treat risk factors for ulceration

Classification

In a person with diabetes and a foot ulcer, use the SINBAD system for communication 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: (S, L)
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In a person with diabetes and a foot ulcer, when resources 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 characterisation of each of the composing variables. (C, L)
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Do not use any of the currently available classification/scoring systems to offer an individual outcome prognosis for a person with diabetes and a foot ulcer. (S, L)
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To classify a person with diabetes and an infected foot ulcer, use the IDSA/IWGDF (2015 version) system. (S, L)
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To classify a person with diabetes and an infected foot ulcer, when resources exist in addition to an appropriate level of expertise and it is considered feasible, consider using the WIfI system. (C, L)
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In a person with diabetes, peripheral artery disease and a foot ulcer, consider using the WIfI system as a means to stratify healing likelihood and amputation risk. (C, L)
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Use the SINBAD system score for any regional/national/international audits, to allow comparisons between institutions on the outcomes of people with diabetes and a foot ulcer. (S, L)
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Table: SINBAD system

Category Definition Score
Site Forefoot 0
Midfoot and hindfoot 1
Ischemia Pedal blood flow intact: at least one palpable pulse 0
Clinical evidence of reduced pedal flow 1
Neuropathy Protective sensation intact 0
Protective sensation lost 1
Bacterial Infection None 0
Present 1
Area Ulcer Ulcer <1cm2 0
Ulcer ≥1 cm2 1
Depth Ulcer confined to skin and subcutaneous tissue 0
Ulcer reaching muscle, tendon or deeper 1
Total Possible Score 0-6

Table: WIfI system

Table: IDSA/IWGDF system

Clinical manifestations Infection severity PEDIS grade
Wound lacking purulence or any manifestations of inflammation Uninfected 1
Presence of ≥ 2 manifestations of inflammation (purulence, or erythema, tenderness, warmth, or induration), but any cellulitis/erythema extends ≤ 2cm around the ulcer, and infection is limited to the skin or superficial subcutaneous tissues; no other local complications or systemic illness Mild 2
Infection (as above) in a patient who is systemically well and metabolically stable but which has ≥ 1 of the following characteristics: cellulitis extending >2cm, lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, and involvement of muscle, tendon, joint or bone Moderate 3
Infection in a patient with systemic toxicity or metabolic instability (e.g. fever, chills, tachycardia, hypotension, confusion, vomiting, leucocytosis, acidosis, severe hyperglycaemia, or azotaemia) Severe 4

Table: Levels of care for diabetes-related foot disease

  • Level 1
    • General practitioner, podiatrist, and diabetes nurse
  • Level 2
    • Diabetologist, surgeon (general, orthopaedic, or foot/ podiatric), vascular specialist (endovascular and open revascularisation), infectious disease specialist or clinical microbiologist, podiatrist and diabetes nurse, in collaboration with a pedorthist, orthotist or prosthetist
  • Level 3
    • A level 2 foot centre that is specialized in care for diabetes-related foot disease, with multiple experts from several disciplines each specialised in this area working together, and that acts as a tertiary reference centre

Infection

Diagnose a soft tissue diabetes-related infection clinically, based on the presence of local or systemic signs and symptoms of inflammation. (S, L)
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Asses the severity of any diabetes-related foot infection using the IWGDF/IDSA classification scheme. (S, L)
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Consider hospitalising all persons with diabetes and a foot infection who have either a severe foot infection as classified by the IWGDF/IDSA classification, or a moderate infection which is associated with key relevant morbidities. (C, L)
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Assess inflammatory serum biomarkers such as C-reactive protein, erythrocyte sedimentation rate, or procalcitonin in a person with diabetes and a possible infected foot ulcer for whom the clinical examination is diagnostically equivocal or uninterpretable. (U, U)
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For diagnosing diabetes-related foot soft-tissue infection, we suggest not using foot temperature (however measured) or quantitative microbial analysis. (C, L)
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In a person with suspected soft tissue diabetes-related foot infection, consider a sample for culture to determine the causative microorganisms, preferably by aseptically collecting a tissue specimen (by curettage or biopsy) from the wound. (C, M)
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Use conventional, rather than molecular, microbiology techniques for the first-line identification of pathogens from soft tissue or bone samples in a patient with a diabetes-related foot infection. (S, M)
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In a person with diabetes, consider using a combination of probe-to-bone test, plain X-rays, and erythrocyte sedimentation rate, or C-reactive protein, or procalcitonin as the initial studies to diagnose osteomyelitis of the foot. (C, L)
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Perform magnetic resonance imaging when the diagnosis of diabetes-related osteomyelitis of the foot remains in doubt despite clinical, plain X-rays and laboratory findings. (S, M)
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Consider using positron emission tomography, leukocyte scintigraphy or single photon emission computed tomography as an alternative to magnetic resonance imaging for the diagnosis of diabetes-related osteomyelitis of the foot. (C, L)
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In a person with diabetes for whom there is suspicion of osteomyelitis of the foot (before or after treatment), consider obtaining bone (rather than soft tissue) samples for culture, either intraoperatively or percutaneously. (C, M)
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Do not treat clinically uninfected foot ulcers with systemic or local antibiotic therapy when the goal is to reduce the risk of new infection, or to promote ulcer healing. (U, U)
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Use any of the systemic antibiotic regimens that have shown to be effective in published randomised controlled trials at standard (usual) dosing to treat a person with diabetes and a soft tissue infection of the foot. (S, H)
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Administer antibiotic therapy to a patient with a skin or soft tissue diabetic foot infection for a duration of 1 to 2 weeks. (S, H)
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Consider continuing treatment, perhaps for up to 3 to 4 weeks, if the infection is improving but is extensive and is resolving slower than expected or if the patient has severe peripheral artery disease. (C, L)
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If evidence of infection has not resolved after 4 weeks of apparently appropriate therapy, reevaluate the patient, and reconsider the need for further diagnostic studies or alternative treatments. (S, L)
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Select an antibiotic agent for treating a diabetes-related foot infection based on: the likely or proven causative pathogen(s) and their antibiotic susceptibilities; the clinical severity of the infection; published evidence of the efficacy of the agent for infections of the diabetes-related foot; risk of adverse events including collateral damage to the commensal flora; the likelihood of drug interactions; agent availability and, costs. (U, U)
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Select an antibiotic agent for treating a diabetes-related foot infection based on: the likely or proven causative pathogen(s) and their antibiotic susceptibilities; the clinical severity of the infection; published evidence of the efficacy of the agent for infections of the diabetes-related foot; risk of adverse events including collateral damage to the commensal flora; the likelihood of drug interactions; agent availability and, costs. Best Practice StatementTarget aerobic gram-positive pathogens only (beta-haemolytic streptococci and Staphylococcus aureus including methicillinresistant strains if indicated) for people with a mild diabetes-related foot infection, who have not recently received antibiotic therapy, and who reside in a temperate climate area. (U, U)
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Do not empirically target antibiotic therapy against Pseudomonas aeruginosa in cases of diabetesrelated foot infection in temperate climates, but use empirical treatment of P. aeruginosa if it has been isolated from cultures of the affected site within the previous few weeks, in a person with moderate or severe infection who resides in tropical/subtropical climates. (U, U)
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Consider a duration of up to 3 weeks of antibiotic therapy after minor amputation for diabetesrelated osteomyelitis of the foot and positive bone margin culture and 6 weeks for diabetesrelated foot osteomyelitis without bone resection or amputation. (C, L)
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Use the outcome at a minimum follow-up duration of 6 months after the end of the antibiotic therapy to diagnose remission of diabetes-related osteomyelitis of the foot. (U, U)
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Urgent surgical consultation should be obtained in cases of severe infection or moderate diabetesrelated foot infection complicated by extensive gangrene, necrotizing infection, signs suggesting deep (below the fascia) abscess, compartment syndrome, or severe lower limb ischaemia. (U, U)
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Consider performing early (within 24-48 hours) surgery combined with antibiotics for moderate and severe diabetes-related foot infections to remove infected and necrotic tissue. (C, L)
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In people with diabetes, peripheral artery disease and a foot ulcer or gangrene with infection involving any portion of the foot, obtain an urgent consultation by a surgical specialist as well as a vascular specialist in order to determine the indications and timings of a drainage procedure and/or revascularisation procedure. (U, U)
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Consider performing surgical resection of infected bone combined with systemic antibiotics in a person with diabetes-related osteomyelitis of the foot. (C, L)
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Consider antibiotic treatment without surgery in case of (i) forefoot osteomyelitis without an immediate need for incision and drainage to control infection, and (ii) without peripheral artery disease, and (iii) without exposed bone. (C, L)
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We suggest not using the following treatments to address diabetes-related foot infections: (a) adjunctive granulocyte colony-stimulating factor treatment or (b) topical antiseptics, silver preparations, honey, bacteriophage therapy, or negative pressure wound therapy (with or without instillation). (C, L)
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We suggest not using topical (sponge, cream, and cement) antibiotics in combination with systemic antibiotics for treating either soft-tissue infections or osteomyelitis of the foot in patients with diabetes. (C, L)
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We suggest not using hyperbaric oxygen therapy or topical oxygen therapy as an adjunctive treatment for the sole indication of treating a diabetes-related foot infection. (C, L)
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Table: The classification system for defining the presence and severity of an infection of the foot in a
person with diabetes

Figure: overview of the diagnosis and management of patients with diabetes-related foot infections

Table: Characteristics suggesting a more serious diabetes-related foot infection and potential indications for hospitalisation

Table: Features characteristic of diabetes-related osteomyelitis of the foot on plain X-rays

  • New or evolving radiographic featuresa on serial radiographsb, including:
    • Loss of bone cortex, with bony erosion or demineralisation
    • Focal loss of trabecular pattern or marrow radiolucency (demineralisation)
    • Periosteal reaction or elevation
  • Bone sclerosis, with or without erosion
  • Abnormal soft tissue density in the subcutaneous fat, or gas density, extending from skin towards underlying bone, suggesting a deep ulcer or sinus tract
  • Presence of sequestruma: devitalized bone with radiodense appearance separated from normal bone
  • Presence of involucruma: layer of new bone growth outside previously existing bone resulting, and originating, from stripping off the periosteum
  • Presence of cloacaea: opening in the involucrum or cortex through which sequestrum or
  • granulation tissue may discharge
a some features (e.g., sequestrum, involucrum, and cloacae) are seen less frequently in diabetes-related foot osteomyelitis than in younger patients with osteomyelitis of larger bones
b usually spaced several weeks apart

Table: Duration of antibiotic therapy according to the clinical situation

Infection severity (skin and soft tissues) Route Duration
Class 2: mild oral 1-2 weeks*
Class 3 / 4: moderate / severe oral/initially iv 2-4 weeks
Bone/joint Route Duration
Resected oral/initially iv 2-5 days
Debrided (soft tissue infection) oral/initially iv 1-2 weeks
Positive culture or histology of bone margins after bone resection oral/initially iv 3 weeks
No surgery or dead bone oral/initially iv 6 weeks
*: 10 days following surgical debridement

Offloading

In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer, use a non-removable knee-high offloading device as the first choice of offloading treatment to promote healing of the ulcer. (S, M)
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In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer for which a nonremovable knee-high offloading device is to be used, choose either a total contact cast or nonremovable knee-high walker based upon local resources and the person’s individual factors and acceptability. (C, M)
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In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer for whom a nonremovable knee-high offloading device is contraindicated or not tolerated, consider using either a removable knee-high or ankle-high offloading device as the second choice of offloading treatment to promote healing of the ulcer, and encourage the person to use the device during all weight-bearing activities. (C, L)
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In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer, do not use, and educate the person not to use conventional footwear or standard therapeutic footwear over an offloading device, to promote healing of the ulcer. (S, L)
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In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer for which offloading devices are not available, consider using felted foam in combination with appropriately fitting footwear as the third choice of offloading treatment to promote healing of the ulcer. (C, VL)
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In a person with diabetes and a neuropathic plantar metatarsal head ulcer for which non-surgical offloading treatment fails, consider using Achilles tendon lengthening in combination with an offloading device to promote and sustain healing of the ulcer. (C, M)
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In a person with diabetes and a neuropathic plantar metatarsal head ulcer for which non-surgical offloading treatment fails, consider using metatarsal head resection in combination with an offloading device to promote and sustain healing of the ulcer. (C, L)
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In a person with diabetes and a neuropathic hallux ulcer for which non-surgical offloading treatment fails, consider using joint arthroplasty in combination with an offloading device to promote and sustain healing of the ulcer. (C, L)
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In a person with diabetes and a neuropathic plantar ulcer on metatarsal heads 2-5 for which nonsurgical offloading treatment fails, consider using a metatarsal osteotomy in combination with an offloading device to promote and sustain healing of the ulcer. (C, VL)
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In a person with diabetes and a neuropathic plantar or apex ulcer on digits 2-5, secondary to a flexible toe deformity, use a digital flexor tenotomy to promote and sustain healing of the ulcer. (S, M)
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In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer with either mild infection or mild ischaemia, consider using a non-removable knee-high offloading device to promote healing of the ulcer. (C, L)
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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 offloading device to promote healing of the ulcer. (C, L)
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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 use a removable offloading intervention over no offloading based on the person's individual factors, to promote healing of the ulcer. (S, VL)
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In a person with diabetes and a neuropathic plantar rearfoot ulcer, consider using a non-removable knee-high offloading device over a removable offloading device to promote healing of the ulcer. (C, VL)
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In a person with diabetes and a non-plantar foot ulcer, use a removable offloading device, footwear modifications, toe spacers, orthoses, or digital flexor tenotomy, depending on the type and location of the foot ulcer, to promote healing of the ulcer. (S, VL)
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In a person with diabetes and a foot ulcer for which a knee-high or ankle-high offloading device is used, consider also using a shoe lift on the contralateral limb to improve the person’s comfort and balance while walking in the device. (C, VL)
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Wound Healing

All recommendations should be considered to be adjunctive to best standard of care when best standard of care alone has failed to heal the ulcers. This should include sharp debridement and basic wound dressings, which according to the IWGDF Practical Guidelines, should be dressings to absorb exudate and maintain a moist wound healing environment.
Do not use autolytic, biosurgical, hydrosurgical, chemical or laser debridement over standard of care. (S, L)
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Do not routinely use enzymatic debridement as opposed to standard of care (i.e. sharp debridement) to improve wound healing outcomes in people with diabetes and a foot ulcer. (S, L)
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n specific situations where the availability of sharp debridement may be limited by access to resources and/ or availability of skilled personnel, consider using enzymatic debridement. (C, L)
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Do not use any form of ultrasonic debridement over standard of care (i.e. sharp debridement). (S, L)
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Do not use surgical debridement in those for whom sharp debridement can be performed outside a sterile environment.

(S, L)
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We recommend the frequency of sharp debridement should be determined by the clinician based on clinical need. (S, L)
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Do not use topical antiseptic or antimicrobial dressings for wound healing of diabetes-related foot ulcers. (S, M)
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Do not use honey (or bee related products) for the purpose of wound healing in diabetes-related foot ulcers. (S, L)
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Do not use collagen or alginate dressings for the purpose of wound healing of diabetes-related foot ulcers. (S, L)
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Consider the use of the sucrose-octasulfate impregnated dressing as an adjunctive treatment, in addition to the best standard of care, in non-infected, neuro-ischaemic diabetes-related foot ulcers which have had insufficient change in ulcer area with best standard of care including appropriate offloading for at least 2 weeks. (C, M)
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Do not use topical phenytoin for the purpose of wound healing in diabetes-related foot ulcers. (S, L)
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Do not use any dressing based or topical applications impregnated with herbal remedies for the sole purpose of wound healing in diabetes-related foot ulcers. (S, L)
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Consider the use of hyperbaric oxygen as an adjunct therapy in neuro-ischemic or ischemic diabetes-related foot ulcers where standard of care alone has failed and where resources already exist to support this intervention. (C, L)
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Consider the use of topical oxygen as an adjunct therapy to standard of care for wound healing in people with diabetes-related foot ulcers where standard of care alone has failed and resources exist to support this intervention. (C, L)
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Do not use other gases (e.g. cold atmospheric plasma, ozone, nitric oxide, CO2) in comparison to standard of care for wound healing in people with diabetes-related foot ulcers. (S, L)
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Do not use any interventions reported in the field of physical therapies for wound healing in the management of diabetes-related foot ulcers. (S, L)
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We suggest not using cellular skin substitute products as a routine adjunct therapy to standard of care for wound healing in patients with diabetes-related foot ulcers.

(C, L)
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We suggest not using acellular skin substitute products as a routine adjunct therapy to standard of care for wound healing in patients with diabetes-related foot ulcers. (C, L)
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Do not use autologous skin graft skin substitute products as an adjunct therapy for wound healing in patients with diabetes-related foot ulcers. (S, L)
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With the exception of the autologous leucocyte, platelet and fibrin patch we suggest not using autologous platelets therapy (including blood bank derived platelets) as an adjunct therapy to standard of care. (C, L)
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Consider the use of autologous leucocyte, platelet and fibrin patch for diabetes-related foot ulcers as an adjunctive therapy to standard of care, where best standard of care alone has been ineffective, and where the resources and expertise exist for the regular venepuncture required. (C, M)
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We suggest not using other cell therapy as an adjunct therapy to standard of care for wound healing in people with diabetes-related foot ulcers. (C, L)
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We suggest not using growth factor therapy as an adjunct therapy to standard of care for wound healing in people with diabetes-related foot ulcers. (C, L)
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Consider the use of placental derived products as an adjunct therapy to standard of care for wound healing in people with diabetes-related foot ulcers where standard of care alone has failed. (C, L)
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Do not use pharmacological agents promoting perfusion and angiogenesis to improve wound healing outcomes over standard of care. (S, L)
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Do not use pharmacological agents that supplement vitamins and trace elements to improve wound healing outcomes over standard of care. (S, L)
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Do not use pharmacological agents that stimulate red cell production or protein supplementation to improve wound healing outcomes over standard of care. (S, L)
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Do not use other pharmacological agents to improve wound healing outcomes over standard of care. (S, L)
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Consider the use of Negative Pressure Wound Therapy as an adjunct therapy to standard of care for the healing of postsurgical diabetes-related foot wounds. (C, L)
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Do not use Negative Pressure Wound Therapy as an adjunct therapy to standard of care for the healing of non-surgically related diabetes foot ulcers. (S, L)
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We do not recommend any specific educational and lifestyle support programmes over standard of care to improve healing of diabetes-related foot ulcers. (S, L)
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Charcot’s neuro-osteo-arthropathy

Diagnosis

Always consider active Charcot neuro-osteoarthropathy in a person with diabetes mellitus, neuropathy and intact skin when there are clinical findings of an increase in temperature, oedema, and/or redness of the foot, compared to the contralateral foot. (U, U)
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Consider using infrared thermometry to measure skin temperature of the feet in a person with diabetes mellitus and suspected Charcot neuro-osteoarthropathy with intact skin, using a standardised approach to the measurement of temperatures to allow for more accurate comparison over time. (C, L)
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When using infrared thermometry to measure skin temperature of the feet in a person with diabetes mellitus and suspected active Charcot neuro-osteoarthropathy with intact skin, consider calculating temperature difference between both legs, using the highest temperature on the affected foot or ankle in comparison with the same anatomic point on the contralateral extremity. (C, L)
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In a person with diabetes mellitus with bilateral active Charcot neuro-osteoarthropathy (CNO) and intact skin or with unilateral CNO and intact skin in the absence of the contralateral limb, ascending temperature gradients (toe-knee) may be useful for comparison over time. (U, U)
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Initiate knee high immobilization/offloading promptly while further diagnostic studies are performed to confirm or rule out active Charcot neuro-osteoarthropathy (CNO) when active CNO is suspected in a person with diabetes mellitus and intact skin. (S, L)
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Perform plain X-ray of the foot and ankle in a person with diabetes mellitus and suspected active Charcot neuro-osteoarthropathy. Ideally, bilateral plain X-rays should be performed, if possible, for comparison purposes. (U, U)
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Perform X-rays that include the anteroposterior (AP), medial oblique, and lateral projections in a person with diabetes mellitus and suspected active Charcot neuro-osteoarthropathy. The ankle and foot views should include the AP, mortise, and lateral projections. Ideally, standing (also known as “weight- bearing”) radiographs should be performed. If a patient is not able to bear weight on their feet, non-weight-bearing radiographs are an alternative, but may not demonstrate malalignments that are more apparent in the standing position. (U, U)
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Perform Magnetic Resonance Imaging in a person with diabetes mellitus and suspected active Charcot neuro-osteoarthropathy with normal appearance of the plain X-rays to diagnose or exclude the disease and its activity. (S, M)
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If Magnetic Resonance Imaging is unavailable or is contraindicated in a person with diabetes mellitus and suspected active Charcot neuro-osteoarthropathy, consider a nuclear imaging scan (scintigraphy), CT (computed tomography) scan, or SPECT-CT (Single Photon Emission Computed Tomography) to support the diagnosis of active Charcot neuro-osteoarthropathy. (C, L)
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We suggest not using C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), white blood count, alkaline phosphatase, or other blood tests in a person with diabetes mellitus and suspected active Charcot neuro-osteoarthropathy with intact skin to diagnose or exclude the disease. (C, L)
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Identification of Remission

Consider measurement of skin temperature of the affected and unaffected limb with serial examinations to monitor disease activity in a person with diabetes mellitus and active Charcot neuro-osteoarthropathy with intact skin. (C, L)
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We suggest not using soft tissue oedema alone to determine when active Charcot neuroosteoarthropathy is in remission. (C, L)
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We suggest that the findings of temperature measurement, clinical oedema, and imaging should all be considered when concluding that active Charcot neuro-osteoarthropathy is in remission. (C, L)
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We suggest that frequency of appointments for assessing disease activity in active Charcot neuroosteoarthropathy should depend on specific factors such as fluctuation in oedema volume, comorbidities, the risks associated with treatment and recovery, access to assistance with home treatment needs, and a person’s progress and recovery. (C, L)
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Treatment

Use a non-removable knee-high device to immobilise and offload the foot to promote remission of the disease, and prevention or progression of deformity in a person with active Charcot neuroosteoarthropathy and intact skin. (S, L)
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Consider using a total contact cast in the treatment of active Charcot neuro-osteoarthropathy with intact skin in a person with diabetes mellitus. A knee-high walker rendered non-removable can be considered as a second choice in order to immobilise and offload the foot. (C, L)
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A removable knee-high device worn at all times can be considered as the third treatment choice in a person with diabetes mellitus, active Charcot neuro-osteoarthropathy and intact skin of the foot for whom a non-removable knee-high offloading device is contraindicated or not tolerated. (C, L)
620
We suggest not to use a below the ankle offloading device (e.g. surgical shoe, postoperative sandal, custom moulded shoe, or slipper cast) in the treatment of active Charcot neuro-osteoarthropathy and intact skin, given the inadequate immobilisation of the diseased bone and joints, and limited offloading capacity. (C, L)
620
Treatment with a knee-high offloading device should be considered as soon as possible once the diagnosis of active Charcot neuro-osteoarthropathy is considered. (S, L)
620
In a person with active Charcot neuro-osteoarthropathy who is being treated with a knee-high device, we suggest using assistive devices to reduce weight-bearing on the affected limb. (C, L)
620
Do not use alendronate, pamidronate, zoledronate, calcitonin, PTH, or methylprednisolone as treatment for active Charcot neuro-osteoarthropathy in a person with diabetes mellitus and intact skin. (S, M)
620
We suggest not to use denosumab as treatment for active Charcot neuro-osteoarthropathy in a person with diabetes mellitus and intact skin. (C, L)
620
We suggest to evaluate the need for vitamin D and calcium supplementation in a person with diabetes mellitus and active Charcot neuro-osteoarthropathy with intact skin during the phase of fracture healing, in doses according to (inter)national guidelines on supplementation in persons at risk for vitamin D deficiency and/or those with insufficient calcium intake. (C, L)
620
In a person with active Charcot neuro-osteoarthropathy and intact skin, and with instability of foot and ankle joints, and/or deformity with a high-risk of developing ulcer in the offloading device, or pain that cannot be sufficiently stabilized in a total contact cast or a non-removable knee-high device, we suggest that surgical intervention should be considered. (C, L)
620

Prevention of Re-Activation

Footwear and/or orthoses that best accommodate and support the shape of the foot/feet and ankle to help prevent re-activation of Charcot neuro-osteoarthropathy (CNO) are recommended in a person with diabetes mellitus, intact skin, treated for active CNO with an off-loading device and who is now in remission. (S, M)
620
When deformity and/or joint instability is present, in order to optimise plantar pressure distribution, below the knee customized devices should be used for additional protection in a person with diabetes mellitus, intact skin, treated for active Charcot neuro-osteoarthropathy who is now in remission. (S, M)
620

Intersocietal PAD guideline

Diagnosis

In a person with diabetes without a foot ulcer, take a relevant history for peripheral artery disease, examine the foot for signs of ischaemia and palpate the foot pulses at least annually, or with any change in clinical status of the feet. (S, L)
620
In a person with diabetes without a foot ulcer, if peripheral artery disease (PAD) is suspected, consider performing pedal Doppler waveforms in combination with ankle-brachial index (ABI) and toe-brachial index (TBI). No single modality has been shown to be optimal for diagnosis of PAD and there is no value above which PAD can be excluded. However, PAD is less likely in the presence of ABI 0.9-1.3; TBI ≥ 0.70; and triphasic or biphasic pedal Doppler waveforms. (C, L)
620
In a person with diabetes and a foot ulcer or gangrene, take a relevant history for peripheral artery disease, examine the person for signs of ischaemia and palpate the foot pulses. (S, L)
620
In a person with diabetes and a foot ulcer or gangrene, evaluate pedal Doppler waveforms in combination with ankle-brachial index (ABI) and toe-brachial index (TBI) measurements to identify the presence of peripheral artery disease (PAD). No single modality has been shown to be optimal for diagnosis of PAD, and there is no value above which PAD can be excluded. However, PAD is less likely in the presence of ABI 0.9-1.3; TBI ≥ 0.70; and triphasic or biphasic pedal Doppler waveforms. (S, L)
620
In a person with diabetes without a foot ulcer in whom a non-emergency invasive foot procedure is being considered, peripheral artery disease should be excluded by performing assessment of pedal Doppler waveforms in combination with ankle-brachial index and toe-brachial index. (U, U)
620

Prognosis

In a person with diabetes and a foot ulcer, or gangrene, consider performing ankle pressures and ankle-brachial index (ABI) measurements to assist in the assessment of likelihood of healing and amputation. Ankle pressure and ABI are weak predictors of healing. A low ankle pressure (e.g. < 50 mmHg) or ABI (e.g. < 0.5) may be associated with greater likelihood of impaired healing and greater likelihood of major amputation. (C, L)
620
In a person with diabetes and a foot ulcer or gangrene consider performing a toe pressure measurement to assess likelihood of healing and amputation. A toe pressure ≥ 30 mmHg increases the pre-test probability of healing by up to 30% and a value < 30mmHg increases the pre-test probability of major amputation by approximately 20%. (C, L)
620
In a person with diabetes and a foot ulcer or gangrene, if toe pressure cannot be performed, consider performing a transcutaneous oxygen pressure (TcPO2) measurement or a skin perfusion pressure (SPP) to assess likelihood of healing. A TcPO2 ≥ 25 mmHg increases the pre-test probability of healing by up to 45% and value < 25 mmHg increases the pre-test probability of major amputation by approximately 20%. A SPP ≥ 40mmHg, increases the pre-test probability of healing by up to 30%. (C, L)
620
In a person with diabetes and a foot ulcer or gangrene it is suggested that the presence of peripheral artery disease and other causes of poor healing should always be assessed. Diabetesrelated microangiopathy should not be considered the primary cause of foot ulceration, gangrene or poor wound healing without excluding other causes. (C, L)
620
In a person with diabetes, peripheral artery disease and a foot ulcer or gangrene, consider using the Wound/Ischaemia/foot Infection (WIfI) classification system to estimate healing likelihood and amputation risk. (C, L)
620

Treatment

In a person with diabetes, peripheral artery disease and a foot ulcer or gangrene who is being considered for revascularisation, evaluate the entire lower extremity arterial circulation (from aorta to foot) with detailed visualization of the below knee and pedal arteries. (U, U)
620
In a person with diabetes, peripheral artery disease, a foot ulcer and clinical findings of ischaemia, a revascularisation procedure should be considered. Findings of ischaemia include absent pulses, monophasic or absent pedal Doppler waveforms, ankle pressure <100 mmHg or toe pressure <60 mmHg. Consult a vascular specialist unless major amputation is considered medically urgent. (U, U)
620
In a person with diabetes, peripheral artery disease, a foot ulcer, and severe ischaemia i.e., an anklebrachial index <0.4, ankle pressure <50mmHg, toe pressure <30mmHg or transcutaneous oxygen pressure <30mmHg or monophasic or absent pedal Doppler waveforms, urgently consult a vascular specialist regarding possible revascularisation. (U, U)
620
In a person with diabetes, peripheral artery disease and a foot ulcer with infection or gangrene involving any portion of the foot, urgently consult a vascular specialist in order to determine the timing of a drainage procedure and a revascularisation procedure. (U, U)
620
In a person with diabetes and a foot ulcer, when the wound deteriorates or fails to significantly improve (e.g. a less than 50% reduction in wound area within 4 weeks) despite appropriate infection and glucose control, wound care, and offloading, reassess the vascular status and consult with a vascular specialist regarding possible revascularisation. (U, U)
620
In a person with diabetes, peripheral artery disease and a foot ulcer or gangrene, avoid revascularisation when the risk–benefit ratio for the probability of success of the intervention is clearly unfavourable. (U, U)
620
In a person with diabetes, peripheral artery disease and a foot ulcer or gangrene who has an adequate single segment saphenous vein in whom infrainguinal revascularisation is indicated and who are suitable for either approach, consider bypass in preference to endovascular therapy. (C, M)
620
A person with diabetes, peripheral artery disease (PAD) and a foot ulcer or gangrene, should be treated in centres with expertise in, or rapid access to, endovascular and surgical bypass revascularisation. In this setting, consider making treatment decisions based on the risk to and preference of the individual, limb threat severity, anatomic distribution of PAD, and the availability of autogenous vein. (U, U)
620
In a person with diabetes, peripheral artery disease and a foot ulcer or gangrene, revascularisation procedures should aim to restore in-line blood flow to at least one of the foot arteries. (U, U)
620
In a person with diabetes, peripheral artery disease and a foot ulcer or gangrene undergoing an endovascular procedure, consider targeting the artery on angiography that supplies the anatomical region of the ulcer, when possible or practical. (C, VL)
620
In a person with diabetes and either a foot ulcer or gangrene who has undergone revascularisation, objectively assess the adequacy of perfusion e.g., using non-invasive bedside testing. (U, U)
620
A person with diabetes, peripheral artery disease and either a foot ulcer or gangrene should be treated by a multidisciplinary team as part of a comprehensive care plan. (U, U)
620
In a person with diabetes and peripheral artery disease the following target levels should be:
  • HbA1c < 8% (< 64 mmol/mol), but higher target HbA1c value can be necessary depending on the risk of severe hypoglycaemia.
  • Blood pressure < 140/ 90 mmHg but higher target levels can be necessary depending on the risk of orthostatic hypotension and other side-effects.
  • Low density lipoprotein target of < 1.8 mmol/L (<70 mg/dLdL) and reduced by at least 50% of baseline. If high intensity statin therapy (with or without ezetimibe) is tolerated, target levels < 1.4 mmol/L (55 mg/dL) are recommended.
(U, U)
620
A person with diabetes and symptomatic peripheral artery disease:
  • should be treated with single antiplatelet therapy,
  • treatment with clopidogrel may be considered as first choice in preference to aspirin
  • combination therapy with aspirin (75 mg to 100 mg once daily) plus low-dose rivaroxaban (2.5 mg twice daily) may be considered for people without a high bleeding risk.
(U, U)
620
In a person with type 2 diabetes and peripheral artery disease: with an eGFR > 30 ml/min/1.73m2, a sodium–glucose cotransporter 2 (SGLT-2) inhibitor or a glucagon-like peptide 1 receptor agonist with demonstrated cardiovascular disease benefit should be considered, irrespective of the blood glucose level. SGLT-2 inhibitors should not be started in drug-naïve people with a diabetes-related foot ulcer or gangrene and temporary discontinuation should be considered in people already using these drugs, until the affected foot is healed. (U, U)
620

Recommendation Grading

Abbreviations

  • AFO: Ankle Foot Orthosis
  • CNO: Charcot Neuro-osteoarthropathy
  • CROW: Charcot Restraining Orthotic Walker
  • CRP: C-reactive Protein
  • CT: Computed Tomography
  • DFI: Diabetic Foot Infection
  • DFO: Diabetes-related Osteomyelitis Of The Foot
  • DFU: Diabetic Foot Ulcer
  • ESR: Erythrocyte Sedimentation Rate
  • HBOT: Hyperbaric Oxygen Therapy
  • HMPAO: Hexa Methyl Propylene Amine Oxime
  • IDFU: Infected Diabetes-related Foot Ulcer
  • IDSA: Infectious Diseases Society Of America
  • IWGDF: International Working Group On The Diabetic Foot
  • MRI: Magnetic Resonance Imaging
  • PAD: Peripheral Arterial Disease
  • PCR: Polymerase Chain Reaction
  • SPECT: Single Photon Emission Computed Tomography
  • TDM: Tomodensitometry

Disclaimer

Overview

Title

Prevention and Management of Diabetic Foot Disease

Authoring Organization

Publication Month/Year

May 13, 2023

Supplemental Implementation Tools

Document Type

Guideline

External Publication Status

Published

Country of Publication

Global

Document Objectives

Serve as reference document to aid health care providers in reducing the global burden of diabetic foot disease.

Target Patient Population

All patients with diabetic foot disease

Target Provider Population

Podiatrists, endocrinologists, vascular surgeons, family practitioners and other providers caring for patients with diabetic foot diease

Inclusion Criteria

Male, Female, Adult, Older adult

Health Care Settings

Ambulatory, Hospital, Outpatient, Operating and recovery room

Intended Users

Nurse, nurse practitioner, physician, physician assistant, podiatrist

Scope

Counseling, Treatment, Management, Prevention

Diseases/Conditions (MeSH)

D017719 - Diabetic Foot, D003929 - Diabetic Neuropathies

Keywords

diabetic foot infection, DFU, diabetic foot, DFD, peripheral neuropathy, foot ulceration

Supplemental Methodology Resources

Data Supplement, Systematic Review Document