Diabetes-related foot disease

Overview 
Theory 
Diagnosis 
Management 
Follow up 
Resources 

Please note that formulations/routes and doses may differ between drug names and brands, drug formularies, or locations. Treatment recommendations are specific to patient groups: see disclaimer

ACUTE

at initial presentation

1st line – wound debridement

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1st line –

wound debridement

Debridement of slough, necrotic tissue, and surrounding callus of the ulcer is recommended, after taking account of relative contraindications such as pain or severe ischemia.[24][63] The goal of debridement is to create a clean wound bed and promote wound healing.

Sharp debridement of ulcers using surgical instruments remains the standard of care, despite a lack of high-quality clinical trials to support its use. [ ]

Numerous alternative debridement techniques exist, including using enzymes, larvae, hydrogels, lasers and ultrasound; however, there is currently insufficient evidence to support the routine use of any of these over sharp debridement, according to the International Working Group on the Diabetic Foot (IWGDF).[63]

Wounds with tunneling (i.e., the presence of deep sinus tracts), copious exudate, or a significant amount of overlying eschar (i.e., dried/desiccated material) should be referred to an interdisciplinary foot clinic for debridement.[64] Surrounding callus should be debrided (usually by a podiatrist) to optimize offloading of the ulcer periphery and facilitate re-epithelialization.

Neuropathic ulcers can usually be debrided without the need for local anesthesia.[40]

There is reasonable-quality evidence that negative-pressure wound therapy after surgical debridement may decrease the time to healing, and the IWGDF and the UK’s National Institute for Health and Care Excellence (NICE) both recommend its use in this circumstance.[9][63] This type of therapy is especially useful in wound preparation for skin grafts and flaps and assists in the closure of deep, large wounds, according to American Diabetes Association (ADA) guidelines.[24]

Plus – wound dressing

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Plus –

wound dressing

Treatment recommended for ALL patients in selected patient group

Evidence is sparse to inform decisions about the best choice of wound dressing for diabetic foot ulcers. Dressings that maintain a moist environment, including nonadherent dressings covered with a layer of gauze or other absorptive material, are commonly used.[65] [ ] [ ] Use of a sucrose octasulfate-impregnated wound dressing is supported by the International Working Group on the Diabetic Foot (IWGDF) and the UK National Institute for Health and Care Excellence, after other modifiable factors such as infection have been treated; however the American Diabetes Association (ADA) does not specifically recommend this type of dressing.[63][66][67]

Split-thickness skin grafting is a helpful option for achieving wound healing in patients with a large epithelial defect that has a tissue bed with healthy granulation. The success rate for autologous skin grafting is high; however, its use over high-pressure areas (namely, the heel and the plantar forefoot overlying the metatarsal heads) may be limited. [ ]

Plus – offloading footwear and devices

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Plus –

offloading footwear and devices

Treatment recommended for ALL patients in selected patient group

Repetitive trauma sustained during ambulation is the most common cause of foot ulcers in patients with diabetes. All patients with diabetes should be encouraged to routinely wear appropriate footwear, even if they do not have any signs of active foot ulceration.

For those with active ulceration, offloading the foot is essential to minimize or avoid this repetitive trauma to achieve ulcer healing.[40]

Well-fitted athletic or walking shoes with customized pressure-relieving orthoses are recommended for people with increased plantar pressures, as demonstrated by plantar calluses.[24] Patients with hammertoes or bunions may require specialized footwear that provide extra depth. Custom-made footwear may be required in patients with significant deformities.

There are no data to support specialized orthotics in average-risk patients.[68]

In people with active ulceration, total contact casts and nonremovable cast-walkers are the most effective options for offloading footwear, although removable cast-walkers and modified footwear can be considered if frequent access to the wound is required, according to guidelines from the International Working Group on the Diabetic Foot (IWGDF).[25][32] Nonremovable devices are contraindicated when there is both mild infection and mild ischemia, or moderate infection or ischemia, or heavy exudate present.

The IWGDF also recommends the following:

In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer, a nonremovable knee-high device should be used as the first choice of offloading treatment: either a total contact cast or nonremovable knee-high walker, with the choice depending on the resources available, technician skills, patient preferences, and the extent of any foot deformity present.

If a nonremovable knee-high device is not tolerated or is contraindicated, a removable knee-high or ankle-high device is recommended second-line, with the patient encouraged to wear the device during all weight-bearing activities.

For neuropathic plantar rearfoot ulcers, consider a nonremovable knee-high offloading device over a removable device.

For nonplantar foot ulcers, use a removable offloading device, footwear modifications, toe spacers, orthoses, or digital flexor tenotomy, depending on the type and location of the foot ulcer.

In any patient using a knee-high or ankle-high offloading device, consider adding a shoe lift on the contralateral limb to improve comfort and balance.

Consider – dietary advice and supplements

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Consider –

dietary advice and supplements

Treatment recommended for SOME patients in selected patient group

Malnutrition, including sarcopenia, is very common in patients with diabetes and may impair wound healing. Patients should be advised that a balanced diet, with adequate fluids, calories, proteins and nutrients is critical to the ulcer healing process.[72] Patients should be screened for risk of malnutrition, and if present, malnutrition should be addressed with dietary counseling and supplementation as needed. Nutritional goals should ideally be addressed within the context of an interdisciplinary team, which may include podiatrists, dietitians, surgeons, primary care physicians, dermatologists, and wound care specialists.[72] Optimal glycemic control is essential.

Caloric needs are high when a diabetic foot ulcer is present. Indirect calorimetry is the preferred method for identifying energy needs in individual patients.[72] As a general guide, offer most people at risk of nutritional deficiencies a minimum of 30-35 calories per kg body weight per day, 1.25 to 1.50 g of protein per kg body weight per day, and 1 mL/kcal/day of fluid intake. Aiming for a lower calorie intake, while maintaining protein goals, may be more appropriate for patients with a high body mass index. Priority should be given to nutrient dense foods.[72] Between meals, oral nutrition supplements may be required as needed to provide additional protein and micronutrients. Where patients are unable to meet their energy needs despite nutrition interventions, enteral and parenteral feeding should be considered.

Vitamins and minerals should be included as part of nutritional assessments and supplementation programs.[72]

with mild infection

Plus – oral antibiotic therapy

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Plus –

oral antibiotic therapy

Treatment recommended for ALL patients in selected patient group

Mild infection is defined as the presence of ≥2 of the following: local swelling or induration, erythema 0.5 cm to <2 cm around the wound, local tenderness or pain, local increased warmth, or purulent discharge (exclude other causes of inflammatory response, such as trauma, gout, acute Charcot neuro-osteoarthropathy, fracture, thrombosis, and venous stasis).[44]

For guidance on collecting samples for microbiologic culture.

Do not start antibiotics if there are no active signs or symptoms of infection, for example with the goal of reducing the risk of future infection, or to promote healing.

Prompt initiation of an empiric antibiotic regimen is recommended when there are signs of infection: the choice of antibiotic should be based on the likely etiological agents, local antibiotic policy, and/or the advice of a microbiologist. When choosing an antibiotic for people with a suspected diabetic wound infection, also take account of: the severity of the diabetic foot infection according to the International Working Group on the Diabetic Foot (IWGDF)/IDSA or WIfI classification (mild, moderate, or severe; see Criteria for more details); the risk of developing complications; previous microbiologic results (including previous multiresistant organisms); previous antibiotic use; and patient preferences.[9][44]

Treat with a suitable oral empiric antibiotic regimen. Gram-positive cocci (staphylococci and streptococci) are the most common pathogens in acute infections and narrow-spectrum therapy is appropriate.

Options recommended by the IWGDF and IDSA if there are no complicating features are a semisynthetic penicillinase-resistant penicillin (IWDGF/IDSA suggest cloxacillin, which is not available in the US; dicloxacillin would be a suitable alternative) or cephalexin. If the patient has allergy or intolerance alternatives include clindamycin, levofloxacin, moxifloxacin, trimethoprim/sulfamethoxazole, or doxycycline.[44]

In patients with recent antibiotic exposure, amoxicillin/clavulanate, levofloxacin, moxifloxacin, or trimethoprim/sulfamethoxazole are recommended options.[44]

If MRSA is suspected or confirmed, use linezolid, trimethoprim/sulfamethoxazole, clindamycin, levofloxacin, moxifloxacin, or doxycycline.[44]

Most patients with mild infection can be treated in the community.

Definitive therapy should be based on culture results and clinical response to the empiric regimen.

Systemic fluoroquinolone antibiotics (e.g., levofloxacin, moxifloxacin) may cause serious, disabling, and potentially long-lasting or irreversible adverse events. This includes, but is not limited to: tendinopathy/tendon rupture; peripheral neuropathy; arthropathy/arthralgia; aortic aneurysm and dissection; heart valve regurgitation; dysglycemia; and central nervous system effects including seizures, depression, psychosis, and suicidal thoughts and behavior.[69] Prescribing restrictions apply to the use of fluoroquinolones, and these restrictions may vary between countries. In general, fluoroquinolones should be restricted for use in serious, life-threatening bacterial infections only. Some regulatory agencies may also recommend that they must only be used in situations where other antibiotics, that are commonly recommended for the infection, are inappropriate (e.g., resistance, contraindications, treatment failure, unavailability). Consult your local guidelines and drug information source for more information on suitability, contraindications, and precautions.

Antibiotic therapy should be continued for 1-2 weeks for patients with a skin or soft tissue infection.[44] If the infection is improving but is extensive and is taking longer than expected to resolve, or if the patient has severe peripheral arterial disease, 3-4 weeks of antibiotic treatment may be appropriate.[44] Further diagnostic tests or alternative treatments may need to be considered if the infection has not resolved after 4 weeks.[44]

Primary options

dicloxacillin: 500 mg orally four times daily

cephalexin: 500 mg orally four times daily

clindamycin: 300-450 mg orally three to four times daily

levofloxacin: 500-750 mg orally once daily

moxifloxacin: 400 mg orally once daily

sulfamethoxazole/trimethoprim: 160 mg orally twice daily

doxycycline: 100 mg orally twice daily

amoxicillin/clavulanate: 875 mg orally twice daily

linezolid: 600 mg orally twice daily

with moderate-to-severe infection

Plus – oral or intravenous antibiotic therapy

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Plus –

oral or intravenous antibiotic therapy

Treatment recommended for ALL patients in selected patient group

Moderate infection in an adult is defined as a patient with no systemic manifestations and involving erythema extending ≥2 cm from the wound margin, and/or tissue deeper than skin and subcutaneous tissues (e.g., tendon, muscle, joint, and bone).[44]

Severe infection in an adult is defined as any foot infection with associated manifestations of systemic inflammatory response syndrome, as manifested by ≥2 of the following: temperature > 38°C or < 36°C, heart rate > 90 beats/min, respiratory rate >20 breaths/min, or PaCO₂ < 4.3 kPa (32 mmHg), WBC count >12 × 10⁹ cells/L (12,000/microlitre) (leukocytosis) or <4 × 10⁹ cells/L (4000/microlitre) (leukopenia); or a normal WBC count with >10% immature (band) forms.[44]

Should be promptly referred to an established interdisciplinary diabetic foot clinic for further management.

Prompt initiation of an empiric antibiotic regimen is recommended when there are signs of infection, with the choice of antibiotic based on the severity of the infection and the likely etiological agents, with guidance from local agencies if available.

Consider hospital admission if the patient has a moderate infection that is complex (e.g., wound penetrates to subcutaneous tissues, contains a foreign body, or has discoloration, necrosis or gangrene), associated with severe foot ischemia or metabolic or hemodynamic instability, or if outpatient management has failed or is inappropriate, for example, requiring intravenous therapy or frequent dressing changes.[44]

Severe infections are usually treated as an inpatient with parenteral, broad-spectrum, empiric antibiotics. Oral antibiotics should generally not be used for severe infections, except as follow-on (switch) after initial parenteral therapy.

The IDSA and International Working Group on the Diabetic Foot recommend the following antibiotic options.[44]

No complicating features: amoxicillin/clavulanate, ampicillin/sulbactam, cefuroxime, cefotaxime, or ceftriaxone.

In patients with recent antibiotic exposure: piperacillin/tazobactam, cefuroxime, cefotaxime, ceftriaxone, or ertapenem.

Macerated ulcer or warm climate: consider piperacillin/tazobactam, meropenem, imipenem/cilastatin or ciprofloxacin.

Ischemic limb/necrosis/gas forming: amoxicillin/clavulanate, ampicillin/sulbactam, piperacillin/tazobactam, ertapenem, meropenem, imipenem/cilastatin, or one of cefuroxime, cefotaxime, or ceftriaxone plus clindamycin or metronidazole.

If the patient has risk factors for extended-spectrum beta-lactamase drug resistance: ertapenem, meropenem, imipenem/cilastatin, ciprofloxacin, amikacin, or colistimethate.

Definitive therapy should be based on culture results and clinical response to the empiric regimen.

Systemic fluoroquinolone antibiotics (e.g., ciprofloxacin) may cause serious, disabling, and potentially long-lasting or irreversible adverse events. This includes, but is not limited to: tendinopathy/tendon rupture; peripheral neuropathy; arthropathy/arthralgia; aortic aneurysm and dissection; heart valve regurgitation; dysglycemia; and central nervous system effects including seizures, depression, psychosis, and suicidal thoughts and behavior.[69] Prescribing restrictions apply to the use of fluoroquinolones, and these restrictions may vary between countries. In general, fluoroquinolones should be restricted for use in serious, life-threatening bacterial infections only. Some regulatory agencies may also recommend that they must only be used in situations where other antibiotics, that are commonly recommended for the infection, are inappropriate (e.g., resistance, contraindications, treatment failure, unavailability). Consult your local guidelines and drug information source for more information on suitability, contraindications, and precautions.

Primary options

amoxicillin/clavulanate: 875 mg orally twice daily

ampicillin/sulbactam: 3 g intravenously every 6 hours

cefuroxime sodium: 1.5 g intravenously every 6-8 hours

cefotaxime: 2 g intravenously every 6-8 hours

ceftriaxone: 1-2 g intravenously every 24 hours

piperacillin/tazobactam: 3.375 g intravenously every 6 hours; or 4.5 g intravenously every 6-8 hours

ertapenem: 1 g intravenously every 24 hours

meropenem: 1 g intravenously every 8 hours

imipenem/cilastatin: 500 mg intravenously every 6 hours

cefuroxime sodium: 1.5 g intravenously every 6-8 hours

cefotaxime: 2 g intravenously every 6-8 hours

ceftriaxone: 1-2 g intravenously every 24 hours

-- AND --

clindamycin: 600-900 mg intravenously every 8 hours

metronidazole: 500 mg intravenously every 6-8 hours

ciprofloxacin: 400 mg intravenously every 8-12 hours

amikacin: 15-20 mg/kg intravenously every 24 hours

colistimethate: consult specialist for guidance on dose

Consider – MRSA antibiotic cover

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Consider –

MRSA antibiotic cover

Treatment recommended for SOME patients in selected patient group

If MRSA is suspected or confirmed: add or substitute with vancomycin, linezolid, daptomycin, trimethoprim/sulfamethoxazole, or doxycycline.[44]

Primary options

vancomycin: 15-20 mg/kg intravenously every 8-12 hours

linezolid: 600 mg intravenously every 12 hours

daptomycin: 4-6 mg/kg intravenously every 24 hours

sulfamethoxazole/trimethoprim: 160 mg orally twice daily

doxycycline: 100 mg orally twice daily

Consider – drainage and/or debridement

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Consider –

drainage and/or debridement

Treatment recommended for SOME patients in selected patient group

Seek an urgent surgical opinion in cases of severe infection, or moderate infection with extensive gangrene, necrotizing infection, suspected deep abscess, compartment syndrome, or severe lower limb ischemia.[44] Prompt removal of infected and necrotic tissues (within 24-48 hours), including bone if there is osteomyelitis, in combination with antibiotics has been shown to improve wound healing rates and lower major amputation rates.[44]

ONGOING

after initial definitive treatment

1st line – follow-up and continuing diabetic care ± referral

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1st line –

follow-up and continuing diabetic care ± referral

Patients should be followed up every 1-2 weeks to assess for resolution of infection and check for wound healing. A wound that has not healed or decreased in area by ≥50% within 2-4 weeks should be referred to a diabetic foot clinic or inpatient unit.

Primary care providers should provide basic clinical care at an initial visit for a new diabetic foot ulcer, but they should also have a low threshold to refer to interdisciplinary foot clinics or inpatient units for more focused care. Lack of recognition of ischemia and infection are two major, but avoidable, pitfalls that lead to delayed referral.[88] Interdisciplinary care – usually including at least a podiatrist and vascular surgeon with experience and interest in diabetes-related foot disease, perhaps with orthopedic, infectious disease, dermatologic, and prosthetist/orthotist input – has repeatedly been demonstrated to significantly lower leg amputation rates.[89][90][91][92]

It is important to remember the need for proper management of the diabetes itself (e.g., regular check-ups, maintenance of target blood glucose levels, blood pressure, and lipid management) according to current guidelines. These goals do not change in the presence or absence of diabetes-related foot disease. There is some evidence that intensive glucose control is associated with a long-term reduction in risk of developing diabetic foot ulcers in patients with type 1 diabetes.[61]

Sodium-glucose cotransporter-2 (SGLT2) 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 who develop a foot ulcer or gangrene while already using them, until the foot is healed.[11]

Consider – offloading footwear

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Consider –

offloading footwear

Treatment recommended for SOME patients in selected patient group

The use of specialized therapeutic footwear is recommended for high-risk patients with diabetes, such as those with loss of protective sensation (severe peripheral neuropathy), foot deformities, ulcers, callus formation, poor peripheral circulation, or a history of amputation.[24] There are no data to support specialized orthotics in average-risk patients.[68]

The International Working Group of the Diabetic Foot recommends footwear that accommodates the shape of the feet and fits properly.[25] The inside length of the shoe should be 1-2 cm longer than the foot, and should not be too tight or too loose. The internal width should equal the width of the foot at the metatarsal-phalangeal joints or the widest part of the foot), and the height should allow enough room for all the toes. Evaluate the fit with the patient in the standing position, preferably later in the day.

If there is no appropriate off-the-shelf footwear, or if they have an existing foot deformity, consider prescribing therapeutic footwear such as extra-depth shoes, custom-made footwear, insoles and/or toe orthoses.[25]

Patients with a healed plantar foot ulcer should be prescribed therapeutic footwear that has a demonstrated plantar pressure relieving effect during walking, to help prevent a recurrent plantar foot ulcer. Encourage the person to consistently wear this prescribed footwear, both indoors and outdoors.[25]

Prompt treatment of any pre-ulcerative lesions, excess callus, ingrown toenails, or fungal infections is important.[25]

Consider – offloading surgery

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Consider –

offloading surgery

Treatment recommended for SOME patients in selected patient group

For pressure offloading in patients with active ulceration, where conservative measures have failed, the IWGDF advises surgery can be considered as follows (to be used in combination with an offloading device): achilles tendon lengthening or metatarsal head resection for neuropathic plantar metatarsal head ulcers; joint arthroplasty for neuropathic hallux ulcers; metatarsal osteotomy for neuropathic plantar ulcers on metatarsal heads 2-5; digital flexor tenotomy for neuropathic plantar or apex ulcers on digits 2-5, secondary to a flexible toe deformity; digital flexor tenotomy for nonplantar foot ulcers (depending on its location).[32]

Consider – surgical bypass and/or endovascular intervention

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Consider –

surgical bypass and/or endovascular intervention

Treatment recommended for SOME patients in selected patient group

A revascularization procedure should be considered for anyone with peripheral artery disease, a foot ulcer and clinical findings of ischemia (absent pulses, monophasic or absent pedal Doppler waveforms, ankle pressure <100 mmHg or toe pressure <60 mmHg), and for those with ulcers that do not improve within 4 weeks despite appropriate management.[11] Seek an urgent vascular opinion if there are signs of severe ischemia: ankle-brachial pressure index <0.4, ankle pressure <50 mmHg, toe pressure <30 mmHg, or transcutaneous oxygen pressure <30 mmHg.

Consider – amputation

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Consider –

amputation

Treatment recommended for SOME patients in selected patient group

Minor amputations of the lower extremities (i.e., below the ankle, with toe or partial-foot resections) may be performed on areas with irreversible gangrene.

Major amputations (i.e., above the ankle) are generally reserved for two situations: infection or gangrene that is so extensive that reconstruction is either not possible or will not preserve meaningful function in the affected limb; and patients who have very little or no function in the limb (excluding previous history of stroke or paralysis).[2][11]

Consider – management of cardiovascular risk factors and associated long-term comorbidities

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Consider –

management of cardiovascular risk factors and associated long-term comorbidities

Treatment recommended for SOME patients in selected patient group

In addition to optimizing glycemic control, management of other risk factors and associated conditions is important for course and outcomes.

Chronic kidney disease: renal function should be considered when selecting antibiotic therapy. Check your local drug information source. In patients receiving renal replacement therapy, feet should be protected during the hemodialysis session (e.g., offloading with protective boot).[76]

Cardiovascular disease and risk factors: patients with diabetic foot ulcers are at increased risk of cardiovascular-related morbidity and mortality compared with patients with diabetes without foot ulcers.[77][78][79] Control of blood pressure and lipid levels may reduce risk of vascular complications.[20] All patients should receive regular blood pressure and lipid monitoring along with lifestyle advice and optimal pharmacologic management. Aggressive cardiovascular risk management (blood pressure, lipids, glycemic control) has been demonstrated to reduce mortality in patients with diabetic foot ulcers in one study.[80] Note that overly aggressive antihypertensive treatment may result in reduced limb perfusion, increasing the risk of complications.[81]

Heart failure: edema (associated with heart failure) may affect tissue perfusion and wound healing and should be treated where present.[40]

Depression: has been associated with a higher risk of developing diabetic foot ulcers and also a higher risk of major lower-limb amputation and mortality.[84][85][86][87] Screening for depression is recommended.[81]

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Diabetes-related foot disease

Treatment algorithm

at initial presentation

wound debridement

wound dressing

offloading footwear and devices

dietary advice and supplements

oral antibiotic therapy

Primary options

oral or intravenous antibiotic therapy

Primary options

MRSA antibiotic cover

Primary options

drainage and/or debridement

after initial definitive treatment

follow-up and continuing diabetic care ± referral

offloading footwear

offloading surgery

surgical bypass and/or endovascular intervention

amputation

management of cardiovascular risk factors and associated long-term comorbidities