Context Among persons diagnosed as having diabetes mellitus, the prevalence
of foot ulcers is 4% to 10%, the annual population-based incidence is 1.0%
to 4.1%, and the lifetime incidence may be as high as 25%. These ulcers frequently
become infected, cause great morbidity, engender considerable financial costs,
and are the usual first step to lower extremity amputation.
Objective To systematically review the evidence on the efficacy of methods advocated
for preventing diabetic foot ulcers in the primary care setting.
Data Sources, Study Selection, and Data Extraction The EBSCO, MEDLINE, and the National Guideline Clearinghouse databases
were searched for articles published between January 1980 and April 2004 using
database-specific keywords. Bibliographies of retrieved articles were also
searched, along with the Cochrane Library and relevant Web sites. We reviewed
the retrieved literature for pertinent information, paying particular attention
to prospective cohort studies and randomized clinical trials.
Data Synthesis Prevention of diabetic foot ulcers begins with screening for loss of
protective sensation, which is best accomplished in the primary care setting
with a brief history and the Semmes-Weinstein monofilament. Specialist clinics
may quantify neuropathy with biothesiometry, measure plantar foot pressure,
and assess lower extremity vascular status with Doppler ultrasound and ankle-brachial
blood pressure indices. These measurements, in conjunction with other findings
from the history and physical examination, enable clinicians to stratify patients
based on risk and to determine the type of intervention. Educating patients
about proper foot care and periodic foot examinations are effective interventions
to prevent ulceration. Other possibly effective clinical interventions include
optimizing glycemic control, smoking cessation, intensive podiatric care,
debridement of calluses, and certain types of prophylactic foot surgery. The
value of various types of prescription footwear for ulcer prevention is not
clear.
Conclusions Substantial evidence supports screening all patients with diabetes to
identify those at risk for foot ulceration. These patients might benefit from
certain prophylactic interventions, including patient education, prescription
footwear, intensive podiatric care, and evaluation for surgical interventions.
Among persons diagnosed as having diabetes mellitus, the lifetime risk
of developing a foot ulcer is estimated to be 15%.1 Based
on recent studies, the annual population-based incidence ranges from 1.0%
to 4.1%2 and the prevalence ranges from 4%
to 10%, which suggests that the lifetime incidence may be as high as 25%.3,4Quiz Ref IDLower extremity disease,
including peripheral arterial disease, peripheral neuropathy, foot ulceration,
or lower extremity amputation, is twice as common in diabetic persons compared
with nondiabetic persons and it affects 30% of diabetic persons who are older
than 40 years.5 Foot ulcers cause
substantial emotional, physical, productivity, and financial losses.6-9 The estimated
costs of treating a diabetic foot ulcer were $28 000 in a 1999 US study,10 and $18 000 (with no amputation) and $34 000
(with amputation) in a 2000 Swedish study.11
The most costly and feared consequence of a foot ulcer is limb amputation,
which occurs 10 to 30 times more often in diabetic persons than in the general
population.12,13 Diabetes underlies
up to 8 of 10 nontraumatic amputations, of which 85% follow a foot ulcer.1,3,14 The age-adjusted annual
incidence for nontraumatic lower limb amputations in diabetic persons ranges
from 2.1 to 13.7 per 1000 persons.2 Mortality
following amputation ranges from 13% to 40% at 1 year, 35% to 65% at 3 years,
and 39% to 80% at 5 years—worse than for most malignancies.2
In light of the enormous disease burden of diabetic foot ulcers, it
is crucial to know if they are preventable. This review summarizes and critically
evaluates evidence on the efficacy of identifying diabetic persons at high
risk for foot ulcers and of interventions designed to prevent them.
Assisted by a medical librarian, we conducted a systematic literature
search using the EBSCO (EBSCO Information Services, Birmingham, Ala), MEDLINE,
and the National Guideline Clearinghouse databases for articles published
between January 1980 and April 2004 and used the following phrases: diabetes or diabetic, foot ulcer or infection, and prevention or preventing. The EBSCO
database includes the American Medical Association Collection, Comprehensive
Biomedical Reference Collection, Cumulative Index to Nursing and Allied Health
Literature, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials
Register, Database of Abstracts of Reviews of Effectiveness, Health Business
Fulltext Elite, International Pharmaceutical Abstracts, Comprehensive Nursing
and Allied Health Collection, and the American Medical Association’s
Archive. We also searched (1) the bibliography of each identified article;
(2) the National Guideline Clearinghouse Web site (http://www.guidelines.gov); (3) an extensive printed diabetic foot reference collection15; and (4) several Web sites specializing in issues
related to the diabetic foot.
This search identified 165 articles that addressed preventing diabetic
foot ulcers, including 22 randomized controlled studies, most of which measured
changes in the rates of foot ulceration and amputations related to various
interventions. For topics on which there were only a few randomized controlled
studies, we focused on selected case-control and cohort studies.
Pathophysiology of Diabetic Foot Ulcers
Causative Factors.Quiz Ref IDThe causal
pathways leading to foot ulceration include several component causes, the
most important of which is peripheral neuropathy.16 This
is present to some degree in more than 50% of diabetic persons older than
60 years.17 Peripheral neuropathy must usually
be profound before leading to loss of protective sensation; the consequent
vulnerability to physical and thermal trauma increases the risk of foot ulceration
7-fold.18,19 A second causative
factor in foot ulceration is excessive plantar pressure.20 This
is related to both limited joint mobility (at the ankle, subtalar, and first
metatarsophalangeal joints) and to foot deformities.21-23 In
one study of patients with peripheral neuropathy, 28% with high plantar pressure
developed a foot ulcer during a 2.5-year follow-up compared with none with
normal pressure.24 A third component cause
is trauma, especially when repetitive. Among 669 persons with a foot ulcer,
21% were attributed to rubbing from footwear, 11% were linked to injuries
(mostly falls), 4% to cellulitis complicating tinea pedis, and 4% to self-inflicted
trauma (eg, cutting toenails).25 Persons who
had a previous foot ulceration could withstand fewer cycles of stress to their
feet before an ulcer recurred.26
Contributory Factors. Once a foot ulcer develops,
several factors may contribute to adverse outcomes. The most important is
atherosclerotic peripheral vascular disease, which is twice as common in persons
with diabetes as in persons without diabetes5 and
particularly affects the femoropopliteal and smaller vessels below the knee,
while frequently sparing the pedal vessels.27 Diabetes
is also associated with several intrinsic wound-healing disturbances, including
impaired collagen cross-linking and matrix metalloproteinase function,27,28 and immunologic perturbations, especially
in polymorphonuclear leukocyte function.29,30 Furthermore,
persons with diabetes have a higher rate of onychomycosis and toe-web tinea
infections that can lead to skin disruption.31-34
Having a foot ulcer dramatically worsens physical, psychological, and
social quality of life.6-8,35,36 The
obesity and poor vision that are associated with diabetes may also impair
self-care. Optimal prevention (and treatment) outcomes require both a motivated
patient and an effective medical care system.
Screening to Identify Patients at Risk for Diabetic Foot Ulcers
Quiz Ref IDPreventing foot complications begins with identifying
those at risk. Primary care clinicians should inquire about factors known
to be associated with foot ulcers, namely, previous foot ulceration (relative
risk [RR], 1.6; 95% confidence interval [CI], 1.2-2.3; P = .004),37 prior lower extremity
amputation (RR, 2.8; 95% CI, 1.8-4.3; P<.001),37 long duration (>10 years) of having diabetes (odds
ratio [OR], 3.0; P<.04),38 poor
glycemic control (glycosylated hemoglobin >9%; OR, 3.2; P<.03),38 and impaired vision (acuity
<20/40; RR, 1.9; 95% CI, 1.4-2.6; P<.001).37 Clinicians should also examine the feet for structural
abnormalities (eg, calluses, hammer or claw toes, flat feet, bunions), reduced
joint mobility, dry or fissured skin, tinea, or onychomycosis,39,40 and
also inspect footwear to ensure proper fit.
Screening for Loss of Protective Sensation. Nerve
conduction studies are generally considered the criterion standard for diagnosing
peripheral neuropathy. They are less useful in screening for loss of protective
sensation (ie, degree of neuropathy beyond which the patient has a measurably
increased risk for diabetic foot ulceration),41 and
are not widely available.
Monofilament. The most frequently used instrument
for detecting neuropathy is the nylon Semmes-Weinstein monofilament.42 Inability to perceive the 10g of
force a 5.07 monofilament applies is associated with clinically significant
large-fiber neuropathy (Figure). In
3 prospective studies, the Semmes-Weinstein monofilament identified persons
at increased risk of foot ulceration with a sensitivity of 66% to 91%, a specificity
of 34% to 86%, a positive predictive value of 18% to 39%, and a negative predictive
value of 94% to 95%.37,45,46 Certain
brands of monofilaments are more accurate than others47 and
they should not be used on more than 10 patients without a recovery period
of 24 hours.42,47
While authorities recommend testing 8 to 10 anatomic sites, testing
just 4 plantar sites on the forefoot (great toe and base of first, third,
and fifth metatarsals) identifies 90% of patients with an insensate site.48 Most consider a lack of perception at any site(s)
to be abnormal, but as the threshold for an abnormal test is raised from 1
to 4 insensate sites, the sensitivity remains higher than 90% while the specificity
improves from 60% to 80%.44 Asking the patient
to say “yes” or “no” when asked if he/she believes
the Semmes-Weinstein monofilament is being applied is equally accurate and
quicker than the “forced-choice” method (asking the patient to
correctly identify whether it was at time “A” or “B”
that the monofilament was applied).49
Biothesiometer. A biothesiometer (Xilas Medical,
San Antonio, Tex) is a handheld device that assesses vibration-perception
threshold.50 A rubber tactor is applied to
the distal aspect of the toe and the amplitude is increased to a maximum of
100 V (converted from microns).41,46 In
one study, a vibration-perception threshold of more than 25 V had a sensitivity
of 83%, a specificity of 63%, a positive likelihood ratio of 2.2 (95% CI,
1.8-2.5), and a negative likelihood ratio of 0.27 (95% CI, 0.14-0.48) for
predicting a foot ulceration over 4 years.19,51 A
case-control study with 255 diabetic persons found that having either abnormal
Semmes-Weinstein monofilament perception or a vibration-perception threshold
of more than 25 V predicted foot ulceration with a sensitivity of 100% and
a specificity of 77%.43
Tuning Fork. The tuning fork provides an easy
and inexpensive test of vibratory sensation. With a conventional fork, an
abnormal response occurs when the patient loses vibratory sensation while
the examiner still perceives it.37 With a graduated
(Rydel-Seiffer) fork (Gebrueder Martin, Tuttlingen, Germany), persons indicate
first loss of vibration at the plantar hallux as the intersection of 2 virtual
triangles moves on a scale exponentially from 0 to 8 in a mean (SD) of 39.8
(1) seconds.52 This test correlates more strongly
with biothesiometer results (r, –0.90; P<.001)53 than the conventional
tuning fork,54 but the latter predicted foot
ulceration in 2 studies.37,55 Tuning
fork results are less predictive of ulceration than results from using the
monofilament.37
Screening for Patients With Elevated Plantar Pressure. Devices identifying high plantar pressure include mats to measure
barefoot plantar load distribution and transducers distributed in a removable
shoe insole to measure pressure inside footwear.56 The
numerical values generated are often device-specific and cannot easily be
compared. There is no generally accepted plantar pressure level associated
with an increased risk of diabetic foot ulceration. In case-control studies
using the EMED pressure platform system (Novell, Minneapolis, Minn), a peak
barefoot dynamic pressure of 70 N/cm2 had a sensitivity of 70.0%
and a specificity of 65.1%, while a cutoff of 87.5 N/cm2 had a
sensitivity of 64%, a specificity of 46%, a positive predictive value of 17%,
and a negative predictive value of 90% (Table
1).57,58
Screening for Peripheral Vascular Disease.Quiz Ref IDPeripheral vascular disease is most easily detected by the ankle-brachial
index (ABI), which is the ratio of systolic blood pressure in the ankle to
that in the brachial artery. An ABI of 0.90 or less suggests peripheral vascular
disease, while higher than 1.1 may represent a falsely elevated pressure caused
by medial arterial calcinosis.59 This
test is easily performed, objective, and reproducible.59 One
large study found that the ABI was strongly related to the risk of foot ulceration
(0.3 higher ABI is associated with an RR of 0.83; 95% CI, 0.73-0.96; P = .01).37
Arterial oxygen supply can also be measured by transcutaneous oximetry.59 A transcutaneous oxygen tension higher than 30 mm
Hg correlates with a high likelihood of wound healing.59 Transcutaneous
oxygen tension is also inversely associated with the risk of foot ulceration
(15 mm Hg higher dorsal foot transcutaneous oxygen tension is associated with
an RR of 0.80; 95% CI, 0.69-0.93; P = .004).37 Because accurately measuring transcutaneous oxygen
tension requires expensive equipment and a trained technician, it is not routinely
used.
Educational Interventions to Prevent Foot Ulceration
Patient Education. Most patient education studies
emphasize foot care, but have been short-term and have measured changes in
behavior and cognition rather than the incidence of relevant clinical outcomes
such as ulceration. Patient education formats have included lectures, hands-on
workshops, skills exercises, behavioral modification programs, and telephone
reminders (Table 2).
Two recent reviews concluded that patient education improves short-term
knowledge and may modestly reduce risk of foot ulcerations and amputations.51,67 Larger randomized clinical trials
are needed to assess which patient education formats are the most effective,
how often periodic reinforcement is required, and the long-term effectiveness
of various programs.
Physician Education. Health care organizations
have used various strategies to improve clinicians’ performance with
patient education.68,69 In one
strategy, a computerized registry reminded physicians to enter the patient’s
risk status for lower extremity amputation. After 28 months, the percentage
of patients who had received foot screening and risk assessment increased
from 15% to 76%.68 Project LEAP (Lower-Extremity
Amputation Prevention), developed by the US Department of Health and Human
Services, is a 1-day workshop on diabetes foot care. When given to 560 clinicians
from 85 organizations, it improved the rate of documenting foot care education
from a baseline of 38% to 62% after 9 months.70 More
importantly, appropriate foot care self-management increased from 32% to 48%,
and there was a trend toward reduced lower extremity amputations.70
Another approach is implementing foot care clinical practice guidelines.
An Indian Health Service diabetes program observed 669 patients during a standard
care period (1986-1989) with routine foot screening; a public health period
(1990-1993) with an annual foot examination and initial risk stratification
to give those at high-risk special interventions; and a staged diabetes management
period (1994-1996) during which clinicians used clinical practice guidelines.71 The average lower-extremity amputation incidence
per 1000 diabetic person-years was 29 during the standard care period, 21
during public health, and 15 during staged management. The overall reduction
in lower extremity amputation was 48% (P = .02),
and the incidence of first amputation decreased from 21 per 1000 to 6 per
1000 from the first to the third period (P<.001).71
Clinical Practice Guidelines on the Diabetic Foot.Quiz Ref IDPublished guidelines72-77 uniformly
recommend that all diabetic persons have an annual foot examination that includes
assessing for anatomic deformities, skin breaks, nail disorders, loss of protective
sensation, diminished arterial supply, and improper footwear. The clinician
should then assign the patient to a risk category by using any of several
systems. The recommended interventions for various risk groups differ slightly
among the guidelines, but persons at higher risk for foot ulceration should
have more frequent foot examinations.72-77 (Table 3)
Clinical Interventions to Prevent Foot Ulceration
Optimizing Glycemic Control. The Diabetes Complications
and Control Trial reported a 57% reduction in the incidence of clinical neuropathy
in patients managed with intensive compared with conventional glycemic treatment.78 In the United Kingdom Prospective Diabetes Study,
a 1% mean reduction in hemoglobin A1c was associated with a 25%
reduction in microvascular complications, including neuropathy. There was
also a nonsignificant reduction in amputations (by 36%) in the intensive compared
with the conventional treatment group.79
Smoking Cessation. Some but not all studies
have found a direct causal association between tobacco use and foot ulceration
or amputation.37 A case-control study of diabetic
persons in the United Kingdom found the lower risk of leg amputation in those
of South Asian compared with European ancestry (OR, 0.26; 95% CI, 0.11-0.65; P = .004) partly attributable to their lower
rates of smoking (31% vs 57%; P = .03).80 Similarly, a cross-sectional study of 1142 patients
with type 2 diabetes in Jordan found smoking to be a strong predictor of amputation.81
Foot Examination by a Clinician. Foot examinations
did not significantly reduce amputations among 244 diabetic patients in 1
case-control study (OR, 0.55; 95% CI, 0.2-1.7; P = .31).82 These results may reflect the study’s limited
sample size, high rates of foot examination in both case and control patients,
different degree of risk between the groups, as well as the unusually high
rates of diabetes and amputations among the Pima Indian population studied.83 Another randomized study of diabetic persons (N = 91)
with a previous foot ulceration found a significantly reduced risk for ulceration
recurrence (RR, 0.52; 95% CI, 0.29-0.93; P = .03) at
1 year for those who received routine podiatric care.84 Thus,
screening foot examinations are unlikely to reduce the incidence of foot complications
unless they eventuate in appropriate specialist referrals (eg, for intensive
podiatric care and customized footwear; Table
4).
Custom Footwear and Orthotics. Prescription
shoes for high-risk patients should reduce areas of high plantar pressure
and friction and accommodate foot deformities (eg, with a deep, wide toe box
and ample padding).85 Similarly, shoe inserts
should cushion the plantar surface and redistribute pressure over a greater
surface area.85 Clinical data supporting the
benefits of prescription footwear are surprisingly meager. In the largest
of several studies, 400 persons with a history of a foot ulcer (but without
a severe deformity) were randomized to receive extradeep, extrawide therapeutic
shoes with customized neoprene-covered cork inserts; therapeutic shoes with
nylon-covered polyurethane inserts; or instructed to wear usual footwear.86 Persons assigned to therapeutic shoes had a similar
incidence of foot ulcer recurrence as controls.86 These
surprising findings may have resulted from excluding patients with severe
foot deformities, a person’s low baseline prevalence (58%) of “foot
insensitivity,”87 and defining a foot
ulcer as existing for 30 days or longer. This and other studies suggest that
patients at low risk for foot complications may safely wear well-fitting,
good-quality over-the-counter athletic or walking shoes, whereas those with
neuropathy and foot deformities may benefit from custom shoes (Table 5). Larger randomized studies should explore which type of
therapeutic footwear (including stockings) may best reduce ulceration in patients
with neuropathy and deformities and whether patients with only neuropathy
require prescription footwear.
Debridement of Calluses. Calluses (hyperkeratotic
lesions caused by pressure) further increase pressure, which is a component
cause of ulceration. Because debriding hyperkeratoses can reduce peak plantar
pressure by 26%,91 this should be routinely
provided by trained personnel. Wearing proper footwear may not only prevent
but also reduce development of calluses. Among 78 diabetic persons, the mean
size of plantar calluses decreased in direct proportion with the amount of
time spent wearing running shoes.92 Similarly,
among high-risk persons, those who visited podiatrists most frequently (every
3-4 weeks) had the lowest mean plantar pressure before and after callus removal.93 The optimal frequency of podiatric evaluation and
management is uncertain.
Foot Specialist and Multidisciplinary Team Care. A
few studies have assessed the role of foot specialist care as the main intervention
in preventing diabetic foot ulcers.84,94 Among
91 diabetic persons with a healed foot ulcer, there were 20 ulcer recurrences
in those randomized to podiatric care and 32 in the control group after a
median follow-up of 386 days (RR, 0.52; 95% CI, 0.30-0.93; P = .03).84 In another trial
of diabetic persons with neuropathy, 235 were randomized to receive podiatric
care at least twice a year and 263 to receive no podiatric treatment.95 During the study period (≤3 years), there was
no difference in the incidence of foot ulcers, but the podiatric care group
had fewer deep ulcers (6 vs 12), infected ulcers (1 vs 10; P<.01), and hospital admission days (24 vs 346; P<.01).95
Other studies have used multidisciplinary (eg, podiatrists, internists,
surgeons, nurses, dieticians, social workers) care teams. In one study, 341
diabetic persons were examined to categorize baseline risk,96 initiate
appropriate education and interventions, and schedule follow-up foot examinations
and podiatric care.97 After 3 years, the incidence
of lower-extremity amputation was only 1.1 per 1000 persons per year. Among
high-risk persons, those who missed more than 50% of their appointments with
the team were 54 times more likely to develop an ulcer and 20 times more likely
to require an amputation than those who kept most appointments.97
Prophylactic Foot Surgeries. A dramatically
increased interest in reconstructive surgery has occurred in the past 2 decades.72,98-113 One
proposed classification system divides nonvascular foot surgery into elective
(to alleviate pain), prophylactic (to reduce risk of ulceration), curative
(to heal an open wound), and emergent (to help control a limb-threatening
infection).114 Only a few small studies have
reported long-term outcomes for prophylactic procedures, generally aimed at
correcting deformities that increase plantar pressure (Table 6). For example, a short Achilles tendon leads to increased
pull on the calcaneus, elevated plantar-flexory movement about the ankle,
and subsequent elevated forefoot plantar pressure; this may be improved by
tendon lengthening. Preventing foot ulcers in patients with Charcot arthropathy
usually requires an expert pedorthist and potentially a foot surgeon. In this
condition, some advocate surgical options including removal of osseous prominences
and reconstruction of the deformed foot or ankle, but controlled trials are
lacking.103,120
Revascularization Surgery. Vascular surgeons
have developed techniques (eg, bypass grafts from femoral to pedal arteries
and peripheral angioplasty) to improve blood flow to an ischemic foot. While
these procedures help heal ischemic ulcers, no prospective study shows that
they reduce foot ulceration.121 The reported
effect of revascularization procedures on the incidence and site of amputations
varies, but most recent studies suggest benefits.122-124
Cost-Effectiveness. A recent cost of illness
model, based on published data about diabetic complications and the value
of health resources from numerous sources found that the mean annual cost
of treatment in 2001 was $9306 for an uninfected diabetic foot ulcer, $24 582
for an infected foot ulcer, and $45 579 for a foot ulcer with osteomyelitis.125 Another review compiled cost data from 1990 to 1997
from 7 studies—4 conducted in the United States and 3 in other countries.126 After inflation adjustment and currency conversion,
the cost of treating foot ulcers not requiring amputation ranged from $993
to $17 519, and approached $30 724 in 1 study that spanned 2 years
after diagnosis.
A few groups have modeled cost-utility analyses for strategies to prevent
foot ulcers. A Markov model from Sweden of intensive prevention (patient education,
use of appropriate footwear, and access to therapeutic foot care) for high-risk
patients was cost-effective if the incidence of foot ulcers and lower extremity
amputations was reduced by 25%.127 A similar
model for patients with newly diagnosed type 2 diabetes found that implementing
a guideline-based foot program that included intensive glycemic control, regular
foot examinations, risk stratification, patient education, clinician education,
and multidisciplinary foot care increased life expectancy and quality-adjusted
life-years and reduced the incidence of foot complications.128 The
cost of achieving a 10% reduction in the incidence of foot lesions was less
than $25 000 per quality-adjusted life-year gained.128
Diabetes confers a dramatically increased risk of foot ulceration, but
available evidence suggests that this risk may be reduced to some degree by
appropriate screening and intervention measures. Clinicians should screen
all patients with diabetes to identify those at risk for foot ulceration.
This includes reviewing relevant past history, identifying any current foot
deformities, and especially assessing for loss of protective sensation with
a monofilament. Other helpful screening methods include assessing for peripheral
vascular disease by measuring ABIs, ensuring that the patient is wearing appropriate
footwear, and checking for high plantar pressure when possible.
Screening allows the clinician to assign the patient to a risk category
that dictates both the type and frequency of foot interventions needed. Effective
interventions include patient (and clinician) education. Possibly effective
interventions include optimizing glycemic control, smoking cessation, intensive
podiatric care, and debridement of calluses. The value of prescription footwear
for ulcer prevention is unclear. In selected cases, evaluation for surgical
procedures may be indicated. Each of these interventions, when used appropriately,
may reduce the risk of foot ulceration and its devastating consequences.
Corresponding Author: Nalini Singh, MD,
VA Puget Sound Healthcare System, Mailcode: S-111-ENDO, 1660 S Columbian Way,
Seattle, WA 98108 (Nalini.Singh2@med.va.gov).
Author Contributions: All of the authors had
full access to all of the data in the study and take responsibility for the
integrity of the data and the accuracy of the data analysis except for the
few cases mentioned in the tables.
Study concept and design: Singh, Armstrong,
Lipsky.
Acquisition of data: Singh, Lipsky.
Analysis and interpretation of data: Singh,
Lipsky.
Drafting of the manuscript: Singh, Armstrong,
Lipsky.
Critical revision of the manuscript for important
intellectual content: Singh, Armstrong, Lipsky.
Statistical analysis: Singh.
Administrative, technical, or material support:
Singh, Armstrong, Lipsky.
Study supervision: Lipsky.
Role of the Sponsor: There was no sponsor for
this study and no agency or company reviewed the manuscript.
Acknowledgment: We thank VA Puget Sound Healthcare
System employees Ted Hamilton, MLIS, for his invaluable assistance with the
literature searches, and Christopher Pacheco for providing the initial version
of the monofilament figure. We also thank Edward J. Boyko, MD, MPH, for his
time and expertise in calculating measures of effect in the tables.
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