INTRODUCTION — Foot problems are an important cause of morbidity in patients with diabetes mellitus. The lifetime risk of a foot ulcer for patients with type 1 or 2 diabetes may be as high as 34 percent . Management of diabetic foot ulcers accounts for a large number of inpatient stays, has a high rate of hospital readmission, and is associated with a 2.5-fold risk of death compared with patients with diabetes without foot ulcers [1,2]. A potentially preventable initiating event, most often minor trauma that causes cutaneous injury, can often be identified. Foot amputations, many of which are preventable with early recognition and therapy, may be required in up to 20 percent of diabetic foot ulcers [1,3]. These observations illustrate the importance of frequent evaluation of the feet in patients with diabetes to identify those at risk for foot ulceration . Systematic screening examinations for neuropathic and vascular involvement of the lower extremities and careful inspection of feet may substantially reduce morbidity from foot problems.
Evaluation of the diabetic foot is provided here. A discussion of diabetes-related foot infections (cellulitis and osteomyelitis) and the management of diabetic foot ulcers are found elsewhere. (See "Clinical manifestations, diagnosis, and management of diabetic infections of the lower extremities" and "Management of diabetic foot ulcers".)
RISK FACTORS — Several risk factors are predictive of ulcers and amputation. Early recognition and management of risk factors is important for reducing morbidity of foot ulceration. Most are readily identifiable from the history or physical examination. The most important risk factors are [1,3-5]:
●Previous foot ulceration
●Neuropathy (loss of protective sensation)
The significance of these risk factors was confirmed by the results of a community-based study of 1294 patients with type 2 diabetes . The incidence of lower extremity amputation was 3.8 per 1000 patient-years. Predictors of amputation included foot ulceration (hazard ratio [HR] 5.6, 95% CI 1.2-25), neuropathy (HR 2.6, 95% CI 1.3-5.4), and ankle-brachial index (ABI) ≤0.9 (HR 2.2, 95% CI 1.1-4.4).
Neuropathy, which is present in over 80 percent of diabetic patients with foot ulcers, promotes ulcer formation by decreasing pain sensation and perception of pressure, by causing anatomic deformities (such as hammer toes from greater flexor muscle tone compared with extensor tone, loss of arch, and rocker bottom feet associated with Charcot foot), and by impairing the microcirculation and the integrity of the skin. Once ulcers form, healing may be delayed or difficult to achieve, particularly if infection penetrates to deep tissues and bone and/or there is diminished local blood flow.
Compared with some oral and injectable diabetes agents, sodium-glucose co-transporter 2 (SGLT2) inhibitors may be associated with an increased risk of amputation based on an increased risk observed with canagliflozin in one large, randomized clinical trial . Patients with history of amputation or peripheral vascular disease were at highest absolute risk for this complication. We avoid use of SGLT2 inhibitors in patients who are at increased risk of diabetic foot ulcers. (See "Sodium-glucose co-transporter 2 inhibitors for the treatment of hyperglycemia in type 2 diabetes mellitus", section on 'Amputations'.)
Risk classification — There are several risk classification systems designed to predict foot ulcer in patients with diabetes [8,9]. Risk categorization can be used to design preventive and monitoring strategies (table 1). One system, developed by the International Working Group on the Diabetic Foot, stratifies patients as follows :
●Group 0 – No evidence of neuropathy
●Group 1 – Neuropathy present but no evidence of foot deformity or peripheral vascular disease
●Group 2 – Neuropathy with evidence of deformity or peripheral vascular disease
●Group 3 – History of foot ulceration or lower extremity amputation
In a prospective case-control study of 225 patients with diabetes, stratification using this classification system was predictive of incident ulceration and amputation . During 30 months (mean) of follow-up, ulcers occurred in 5, 14, 13, and 65 percent of patients in groups 0, 1, 2, and 3, respectively. Only patients in groups 2 and 3 had amputations (2 and 26 percent, respectively).
OUR APPROACH — All patients with diabetes should be examined to identify risk for foot ulceration. The feet should be visually inspected at each routine visit to identify problems with nail care, poorly fitting footwear resulting in barotrauma, fungal infections, and callus formation that may result in more severe foot problems. A comprehensive foot examination should be performed annually on patients with diabetes to identify risk factors predictive of ulcers and amputation (table 2) [11,12]. Patients with an existing foot ulcer or with risk factors for foot ulceration (eg, previous foot ulceration, neuropathy, foot deformity, peripheral vascular disease) should be referred to a foot care specialist (table 1).
Our approach to evaluation of the diabetic foot is largely in agreement with the guidelines from the American Diabetes Association (ADA) .
History — Pertinent history to obtain includes duration of diabetes, glycemic control, presence of micro- or macrovascular disease, history of prior foot injury resulting in deformities or prior ulcers, lower limb bypasses or amputation, presence of claudication, and history of cigarette smoking. Two cohort studies have demonstrated an increased risk of foot ulcers in those with a longer history of diabetes [13,14]. This may be related to the finding that the risk of peripheral artery disease and peripheral neuropathy appears to increase with the duration of diabetes [15-17].
The patient should be questioned about foot and leg discomfort. An older scoring system to assess symptoms quantitatively remains a useful guide to collect a history of diabetic neuropathy :
●What is the sensation felt? – Burning, numbness, or tingling (2 points); fatigue, cramping, or aching (1 point). Maximum is 2 points.
●What is the location of symptoms? – Feet (2 points); calves (1 point); elsewhere (no points). Maximum is 2 points.
●Have the symptoms ever awoken you at night? – Yes (1 point).
●What is the timing of symptoms? – Worse at night (2 points); present day and night (1 point); present only during the day (no points). Maximum is 2 points.
●How are symptoms relieved? – Walking around (2 points); standing (1 point); sitting or lying or no relief (no points). Maximum is 2 points.
The total neuropathy symptom score can then be determined:
●0 to 2 – Normal
●3 to 4 – Mild
●5 to 6 – Moderate
●7 to 9 – Severe
Comprehensive foot examination — The annual comprehensive foot examination can be accomplished in the primary care setting and should include inspection, assessment of pedal pulses, and testing for loss of protective sensation (table 2). Several reports indicate that adequate examinations relevant to foot ulceration are often not performed in patients with diabetes [19-21].
A meta-analysis of 16 cohort studies found that the following diagnostic screening tests reliably identified those at risk for foot ulceration :
●Decreased cutaneous sensation with monofilament
●At least one absent pedal pulse
Inspection — The skin should be assessed for integrity, especially between the toes and under the metatarsal heads. Findings that may herald a developing foot ulcer include the following:
●Lesions between adjacent toes due to pressure from tight shoes cramming them together
●Macerated areas between the toes ("athlete's foot"); these lesions are often painless and may go unnoticed until bacterial infection supervenes
●Bunions (callused areas)
The presence of erythema, warmth, or fissures may indicate areas of tissue damage. Patients with evidence of an existing ulcer require additional evaluation. (See 'Evaluation of existing ulcer' below.)
Bony deformities, joint mobility, and gait and balance should also be assessed. Assessment may reveal several abnormalities that result from diabetic neuropathy, such as claw toes and Charcot arthropathy (also called diabetic neuropathic arthropathy). Chronic motor neuropathy often affects the small intrinsic muscles of the feet so that the action of the larger muscles in the anterior tibial compartment is unopposed. This leads to subluxation of the proximal interphalangeal-metatarsal joints, resulting in a claw toe appearance. One consequence of this abnormality is increased pressure on the metatarsal heads, which are a common site of ulcer development (picture 1).
A later complication is Charcot arthropathy, which is characterized by collapse of the arch of the midfoot and abnormal bony prominences (picture 2). These changes are often triggered by injury, inflammation, and hyperperfusion, accompanied by the triad of small muscle wasting, decreased sensation, and abnormal distribution of weight when standing, leading to repetitive microtrauma due to the absence of protective pain sensation . (See "Diabetic neuropathic arthropathy".)
The autonomic neuropathy associated with Charcot arthropathy can lead to several additional problems. Sweating is diminished or absent; as a result, the skin of the feet remains dry and has a tendency to become scaly and cracked, thereby allowing infection to penetrate below the skin. Lack of autonomic tone in the capillary circulation causes shunting of blood from arteries directly into veins, bypassing the tissues that need nutrition. This results in a foot that feels warm and has distended veins and bounding pulses. Despite these apparent signs of adequate perfusion, the foot is vulnerable to local "microvascular" gangrene, will heal very poorly and slowly, and will be less able to resist infection. (See "Screening for diabetic polyneuropathy".)
Assessment of pedal pulses — Assess for peripheral artery disease by asking about a history of claudication and assessing pedal pulses, temperature, and for the presence of dependent rubor, a late finding. If pedal pulses are absent, assess popliteal and femoral pulses. Physical examination findings such as diminished pulses, decrease in skin temperature, thin skin, lack of skin hair, and bluish skin color are not specific enough to guide further management in an individual patient. Patients with clinical evidence of peripheral artery disease should have ankle-brachial index (ABI) testing (noninvasive arterial testing) to guide further management. The presence of peripheral artery disease is highly associated with atherosclerotic cardiovascular disease. (See 'Evaluation of peripheral artery disease' below and "Clinical features and diagnosis of lower extremity peripheral artery disease", section on 'Physical examination'.)
Assessment for loss of protective sensation — Test for loss of protective sensation using a Semmes-Weinstein 5.07 (10 g) monofilament at specific sites to detect loss of sensation in the foot (figure 1), plus any one of the following: vibration using a 128-Hz tuning fork or a biothesiometer, pinprick sensation, and ankle reflexes. The pinprick examination in best performed with a new, clean safety pin, which should be discarded in a sharps container after use.
●Vibration testing – Vibration testing is typically conducted with a 128 Hz tuning fork applied to the bony prominence at the dorsum of the first toe, just proximal to the nail bed. The quickest method of testing is to ask the patient to report the perception of both the start of vibration sensation and the cessation of vibration on dampening. The test should be conducted twice on each great toe. The sensitivity and specificity of vibration testing for peripheral neuropathy have been estimated to be 53 and 99 percent, respectively .
Vibration sense can also be estimated quantitatively with a biothesiometer. This device is essentially an electronic tuning fork that allows the vibration to be adjusted up or down depending upon the voltage applied. The vibration-perception threshold (VPT) is defined as the lowest voltage at which vibration can be sensed on the pulp of the big toe. The value in normal subjects increases with age from approximately 6 volts at age 30 years to 20 volts at age 75 years .
Additional evaluation — Patients who have concerning findings on the comprehensive foot examination require additional evaluation and referral to a foot care specialist.
Evaluation of existing ulcer — The evaluation of an existing diabetic foot ulcer includes careful examination and classification of the wound. Foot ulcers are usually classified into two groups: acute ulcers secondary to dermal abrasion from poorly fitting shoes, and chronic ulcers occurring over areas prone to pressure. Chronic ulceration is probably multifactorial, due to a combination of diabetic neuropathy (with decreased pain sensation and deformity), autonomic dysfunction, and vascular insufficiency. (See "Management of diabetic foot ulcers", section on 'Ulcer classification'.)
The ulcer is examined for drainage, odor, the presence (or absence) of granulation tissue, and any exposed underlying structures, such as tendons, joint capsule, or bone. The wound can be probed gently by an experienced clinician or a surgeon with a sterile, blunt probe to reveal the presence of a sinus track or communication with deeper structures, which may change the wound classification. (See "Management of diabetic foot ulcers", section on 'Management overview'.)
●Signs of infection – The presence of a diabetic foot infection is likely if there is erythema, warmth, tenderness, or swelling (especially with two or more of these findings) around the ulcer site. Infection is even more strongly indicated by pus coming out of an ulcer site and/or a nearby sinus tract.
Osteomyelitis is likely to be present if bone can be seen at the floor of a deep ulcer, or if it can be easily detected by probing the ulcer with a sterile, blunt, stainless steel probe . Other signs that suggest osteomyelitis are an ulcer size larger than 2 x 2 cm and an otherwise unexplained elevation in the erythrocyte sedimentation rate (ESR). An ESR >60 mm/hour or a C-reactive protein (CRP) level >7.9 mg/dL were found to be optimum cutoffs to diagnose osteomyelitis using receiver operative characteristic analyses .
A discussion of diabetes-related foot infections (infected ulcer, cellulitis, and osteomyelitis) is found elsewhere. (See "Clinical manifestations, diagnosis, and management of diabetic infections of the lower extremities".)
●Imaging – Plain radiographs can detect structural foot deformities, soft tissue gas, and foreign bodies and may be able to detect osteomyelitis. However, radiologic changes occur late in the course of osteomyelitis, and negative radiographs do not exclude it. More sensitive imaging techniques that have been used include radionuclide bone imaging, magnetic resonance imaging, and imaging with indium-labeled leukocytes. (See "Clinical manifestations, diagnosis, and management of diabetic infections of the lower extremities", section on 'Diagnosis of underlying osteomyelitis' and "Approach to imaging modalities in the setting of suspected nonvertebral osteomyelitis".)
Evaluation of peripheral artery disease — Patients with clinical evidence of peripheral artery disease should have ABI testing.
ABI is calculated by measuring the systolic blood pressure (by Doppler probe) in the brachial, posterior tibial, and dorsalis pedis arteries . For each leg, the higher of the measurements at the ankle and foot in that limb is divided by the higher of the two (ie, left and right) brachial measurements. The normal ABI is 0.9 to 1.3 and is generally >1.0 because the pressure is higher in the ankle than in the arm. An ABI <0.9 has 95 percent sensitivity for detecting angiogram-positive peripheral artery disease . Patients with extensive vascular calcification and noncompressible arteries may have falsely positive elevations in the ABI. (See "Noninvasive diagnosis of arterial disease", section on 'Ankle-brachial index' and "Clinical features and diagnosis of lower extremity peripheral artery disease", section on 'Physical examination'.)
A low ABI in the absence of a foot ulcer does not correlate with the risk of future foot ulceration ; however, a low ABI in the presence of a foot ulcer suggests that the prognosis will be improved with reconstructive vascular surgery. In one series of patients with neuropathic foot ulcers and severe arterial insufficiency, for example, 35 of 42 extremities (83 percent) with patent bypass grafts achieved and maintained primary healing of their ulcer . A low ABI also indicates more generalized arteriosclerosis and is associated with an increased risk of cardiovascular death .
Evaluation of neuropathy — If vibration sensation is diminished, we assess for other causes of neuropathy (including vitamin B12 deficiency) since diabetic neuropathy is a diagnosis of exclusion. (See "Screening for diabetic polyneuropathy", section on 'Differential diagnosis' and "Overview of polyneuropathy", section on 'Etiology and pathogenesis'.)
For rapidly progressive, atypical, or severe neuropathic syndromes, or if there is motor nerve involvement, referral to a neurologist is indicated.
Preventive foot care — In conjunction with the comprehensive foot exam, advice for prophylactic foot care should be given to all patients. These recommendations are particularly important in patients with existing neuropathy. (See "Patient education: Foot care for people with diabetes (Beyond the Basics)".)
●Avoid going barefoot, even at home, and especially on hot decks and hot sand
●Test water temperature before stepping into a bath
●Trim toenails to shape of the toe, and remove sharp edges with a nail file; do not cut cuticles
●Wash in lukewarm water, dry thoroughly (including between the toes), and check feet daily
●Shoes should be snug, but not tight, and customized if feet are misshapen or have ulcers
●Socks should fit and be changed daily
In a systematic review of foot ulcer prevention interventions, there were few data evaluating prevention of a first foot ulcer . For the prevention of recurrent foot ulcers, customized footwear to reduce plantar pressure and daily foot skin temperature measurements with subsequent preventive action showed some benefit. In one report, as an example, the use of customized shoes reduced the development of a recurrent foot ulcer from 58 to 28 percent over one year of follow-up .
In addition to the foot care measures described above, there are a variety of new technologies utilizing pressure sensors, temperature measurements, and telemetry for monitoring very high-risk patients that may help with early detection and prevention [34,35]. Temperature monitoring involves daily or twice-daily measurements of skin surface temperature with a thermometer equipped with a touch sensor. If a temperature difference (elevation) is detected between a right and left foot site (figure 1), patients are instructed to reduce activity until the temperature normalizes. Whether the benefit of monitoring temperature is specifically related to the monitoring or the heightened attention to foot care in those performing the monitoring is not clear. Additional efficacy and feasibility studies are required before home temperature monitoring can be recommended to reduce the risk of foot ulcers.
SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Diabetes mellitus in adults".)
INFORMATION FOR PATIENTS — UpToDate offers two types of patient education materials, "The Basics" and "Beyond the Basics." The Basics patient education pieces are written in plain language, at the 5th to 6th grade reading level, and they answer the four or five key questions a patient might have about a given condition. These articles are best for patients who want a general overview and who prefer short, easy-to-read materials. Beyond the Basics patient education pieces are longer, more sophisticated, and more detailed. These articles are written at the 10th to 12th grade reading level and are best for patients who want in-depth information and are comfortable with some medical jargon.
Here are the patient education articles that are relevant to this topic. We encourage you to print or e-mail these topics to your patients. (You can also locate patient education articles on a variety of subjects by searching on "patient info" and the keyword(s) of interest.)
●Beyond the Basics topics (see "Patient education: Foot care for people with diabetes (Beyond the Basics)")
SUMMARY AND RECOMMENDATIONS
●The feet should be visually inspected at each routine visit to identify problems with nail care, poorly fitting footwear resulting in barotrauma, fungal infections, and callus formation that may result in more severe foot problems. A comprehensive foot examination should be performed annually on patients with diabetes to identify risk factors predictive of ulcers and amputation (table 2). (See 'Our approach' above.)
●We perform ankle-brachial pressure index (ABI) testing in any patient with symptoms or physical examination findings of peripheral artery disease. (See 'Evaluation of peripheral artery disease' above.)
●Counseling regarding preventive foot care should be given to any patient whose feet are at risk for ulceration. (See 'Preventive foot care' above.)
●We refer patients to a foot care specialist if they have an existing foot ulcer, or if they are at particularly high risk for foot ulceration due to the following risk factors (table 1) (see 'Risk classification' above and 'Our approach' above):
•A previous history of foot ulceration or amputation
•Loss of protective sensation and/or neuropathic foot deformities
•Peripheral vascular disease
ACKNOWLEDGMENT — The editorial staff at UpToDate would like to acknowledge David McCulloch, MD, who contributed to earlier versions of this topic review.