Preventing Diabetic Foot Ulcer Recurrence

in High-Risk Patients
Use of temperature monitoring as a self-assessment tool
LAWRENCE A. LAVERY, DPM, MPH
1
KEVIN R. HIGGINS, DPM
2
DAN R. LANCTOT, BS
2
GEORGE P. CONSTANTINIDES, MS
2
RUBEN G. ZAMORANO, MSW, MPH
2
KYRIACOS A. ATHANASIOU, PHD, PE
3
DAVID G. ARMSTRONG, DPM, PHD
4
C. MAULI AGRAWAL, PHD, PE
5
OBJECTIVE The purpose of this study was to evaluate the effectiveness of a temperature
monitoring instrument to reduce the incidence of foot ulcers in individuals with diabetes who
have a high risk for lower extremity complications.
RESEARCH DESIGN AND METHODS In this physician-blinded, randomized, 15-
month, multicenter trial, 173 subjects with a previous history of diabetic foot ulceration were
assigned to standard therapy, structured foot examination, or enhanced therapy groups. Each
group received therapeutic footwear, diabetic foot education, and regular foot care. Subjects in
the structured foot examination group performed a structured foot inspection daily and recorded
their ndings in a logbook. If standard therapy or structured foot examinations identied any
foot abnormalities, subjects were instructed to contact the study nurse immediately. Subjects in
the enhanced therapy group used an infrared skin thermometer to measure temperatures on six
foot sites each day. Temperature differences 4F (2.2C) between left and right correspond-
ing sites triggered patients to contact the study nurse and reduce activity until temperatures
normalized.
RESULTS The enhanced therapy group had fewer foot ulcers than the standard therapy
and structured foot examination groups (enhanced therapy 8.5 vs. standard therapy 29.3%, P
0.0046 and enhanced therapy vs. structured foot examination 30.4%, P 0.0029). Patients in
the standard therapy and structured foot examination groups were 4.37 and 4.71 times more
likely to develop ulcers than patients in the enhanced therapy group.
CONCLUSIONS Infrared temperature home monitoring, in serving as an early warning
sign, appears to be a simple and useful adjunct in the prevention of diabetic foot ulcerations.
Diabetes Care 30:1420, 2007
F
oot ulcers are among the most com-
mon complications of diabetes (1,2).
Sensory neuropathy is often a major
component in the critical pathway for the
development of diabetic ulcers and am-
putations. Pain is one of the primary nat-
ural warni ng syst ems t hat al ert s
individuals to take action and seek medi-
cal care (3). Because this early warning
system is faulty, individuals with diabetic
neuropathy can sustain injuries that are
not recognized until they are so severe
that full-thickness wounds result (4). In
the diabetic foot patient, involvement to
identify early warning signs of the disease
process is imperative to reduce the inci-
dence of complications.
Inammation is one of the earliest
signs of tissue injury and ulceration (5
8). However, the clinical signs of inam-
mation are usually too subtle to be
detected by patients or even by trained
health care providers (9). We hypothe-
sized that skin temperatures could be
used as a surrogate measure of injury and
localized inammation. Skin temperature
measurements can be easily performed
and assessed by the lay public and have
been used as a diagnostic tool for diabetic
foot ulcerations, decubitus wounds, and
Charcot arthropathy (1020). Pilot work
in this area suggests that high-risk pa-
tients can effectively use an infrared ther-
mometer as a home monitoring tool to
identify inamed tissue and take action to
prevent foot ulceration (21). The aim of
the present study was to evaluate a home
temperature monitoring tool to help
high-risk individuals identify areas on
their feet that are inamed and prone to
ulceration before a wound develops.
RESEARCH DESIGN AND
METHODS This was a single (phy-
sician) blinded, multicenter, randomized
trial with a 15-month evaluation period.
We randomly assigned 173 individuals at
high risk for diabetic foot ulceration to
three treatment groups (Fig. 1). The three
treatment arms involved a standard ther-
apy group, a structured foot examination
group, and an enhanced therapy group.
The study was approved by the hospital
institutional review board. We used a
computer generated randomization list.
The information was sealed in opaque en-
velopes and opened after randomization
and verication that the subject met all of
the inclusion criteria and had none of the
exclusion criteria. Subjects were in-
structed not to discuss their group assign-
ment with the treating physician.
Standard therapy
Standard therapy consisted of lower ex-
tremity evaluation by a physician every 8
weeks, an education program that fo-

From the
1
Department of Surgery, Scott & White Hospital, Texas A&M University Health Science Center,
Temple, Texas;
2
Xilas Medical, San Antonio, Texas; the
3
Department of Bioengineering, Rice University,
Houston, Texas; the
4
Dr. William M. Scholl College of Podiatric Medicine, Rosalind Franklin University of
Medicine and Science, Chicago, Illinois; and the
5
Department of Engineering, University of Texas, San
Antonio, San Antonio, Texas.
Address correspondence and reprint requests to Lawrence A. Lavery, DPM, MPH, 703 Highland Spring
Ln., Georgetown, TX 78628. E-mail: llavery@swmail.org.
Received for publication 30 July 2006 and accepted in revised form 24 September 2006.
L.A.L. is a member of clinical advisory boards for Xilas Medical, holds stock in Xilas Medical, and serves
as a consultant for Xilas Medical. K.A.A. holds stock in Xilas Medical and is a member of the Board of
Directors. C.M.A. holds stock in Xilas Medical and is a member of the Board of Directors.
A table elsewhere in this issue shows conventional and Syste` me International (SI) units and conversion
factors for many substances.
DOI: 10.2337/dc06-1600
2007 by the American Diabetes Association.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby
marked advertisement in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
C l i n i c a l C a r e / E d u c a t i o n / N u t r i t i o n
O R I G I N A L A R T I C L E
14 DIABETES CARE, VOLUME 30, NUMBER 1, JANUARY 2007
cused on foot complications and self-care
practices, and therapeutic insoles and
footwear. The treating podiatrist evalu-
ated the shoes and insoles during regu-
l arl y schedul ed cl i ni c vi si t s and
determined whether any components of
the shoes or insoles needed to be replaced
or repaired. The education segment of
training was provided by a videotape that
addressed the etiology of diabetic foot ul-
cers, risk factors, self-care practices, and
early warning signs of diabetic foot dis-
ease. In addition, all study participants
were provided with a pedometer to record
their daily activity in a logbook.
Patients were advised to inspect their
feet daily. If patients identied an area of
concern on their foot, they were in-
structed to contact the study nurse. The
nurse then scheduled an appointment
with a study investigator without divulg-
ing the treatment group assignment. Pa-
tients were asked not to discuss their
treatment group assignment with the
treating physician.
Structured foot examination
Patients assigned to this treatment
group received standard therapy in ad-
dition to training to conduct a struc-
tured foot inspection twice a day with
the assistance of a mirror to see the bot-
tom of the foot. The objective of the
examination was to identify redness,
di scol orati on, swel l i ng, and l ocal
warmth by palpation. Patients recorded
normal and abnormal observations in a
logbook with pictorial representations
of both feet and a checklist of the
elements to be included in the self-
examination. The intent of the logbook
was to go beyond customary educa-
tion and recommendations for self-
inspection and provide a structured
protocol for evaluation. In addition, the
logbook provided verication that the
examination was performed. If the pa-
tient identied any abnormalities, he or
she was instructed to contact the study
nurse.
Enhanced therapy
In addition to measures implemented in
the standard therapy group, patients as-
signed to the enhanced therapy group
were taught to use a digital infrared ther-
mometer (TempTouch; Xilas Medical,
San Antonio, TX) to measure and record
temperatures on each foot. To standard-
ize training, a videotape was used to teach
subjects how to use the infrared ther-
mometer. The study nurse had each sub-
ject demonstrate the correct use of the
temperature device. Subjects recorded
foot temperatures in a logbook with pic-
torial representations of the top and bot-
tom of both feet and six sites to measure
temperatures: the great toe, the rst,
third, and fth metatarsal head region,
the midfoot, and the heel. Subjects who
had undergone amputation at the stan-
dard evaluation sites were given alterna-
tive sites on the basis of the site of their
previous amputation. If skin tempera-
tures were elevated by 4F (2.2C) com-
pared with the corresponding site on the
Figure 1Study enrollment schematic.
Lavery and Associates
DIABETES CARE, VOLUME 30, NUMBER 1, JANUARY 2007 15
opposite foot for two consecutive days,
subjects were instructed to contact the re-
search nurse and decrease their activity
until temperatures normalized.
Infrared dermal thermometer
The thermometer is equipped with a
touch sensor tip that detects contact
with skin. Thus, to operate the device, the
user places the tip of the device on the
skin, which then automatically triggers a
temperature measurement and displays it
on a liquid crystal display screen. The
thermometer has a gooseneck design,
which allows the user to reach any point
on the bottom or sides of the foot.
Inclusion and exclusion criteria
To be included in the study, subjects were
required to be 1880 years of and to have
a history of foot ulceration, a diagnosis of
diabetes, the ability to provide informed
consent, and ankle-brachial indexes
0.70. Subjects were excluded if they
had open ulcers or open amputation sites,
active osteoarthropathy, severe periph-
eral vascular disease, foot infection, de-
mentia, or other conditions that would
preclude active participation based on the
investigators judgment.
Outcomes and clinical assessment
The primary outcome was foot ulceration,
which was dened using previously es-
tablished criteria (22,23). Aquestionnaire
was administered at the conclusion of the
study to evaluate self-reported daily use of
prescribed shoes and insoles. An ordinal
scale was used to determine whether pa-
tients wore therapeutic shoes 4 h, 48
h, 812 h, or 12 h each day. The neu-
rological assessment consisted of vibra-
tory perception threshold and 10-g
monolament testing using previously
described methods (2426). When as-
sessing monolament results, we re-
corded the number of sites missed of 10
sites tested on each foot. The vascular as-
sessment consisted of palpation of foot
pulses, noninvasive Doppler, and ankle-
brachial indexes.
Sample size justication
Sample size was calculated on the basis of
the proportion of study patients we ex-
pected to develop ulcers during the 15-
mont h t r eat ment per i od. Thes e
reulceration estimates are based on a pre-
vious randomized trial (20) and reports of
reulceration in high-risk patients (35).
We expected that 9% of subjects in the
enhanced treatment group would de-
velop ulcers during the evaluation period
(P
o
0.09) and that 30%of subjects who
received standard therapy would develop
foot ulcers. A power of 0.8 was chosen to
yield a sample size of 55. We expected a
10%dropout rate. Therefore, we planned
to enroll 60 subjects in each group to have
55 subjects complete the study in each
treatment arm.
Analysis plan
To make between-group comparisons on
continuous-type variables, we used
ANOVA for independent samples. For all
exposures, an odds ratio (OR) with a 95%
CI was identied. For all analyses, we
used 0.05. We evaluated the data
using a last observed carried forward in-
tent-to-treat approach (27).
We used a Kaplan-Meier survival
analysis to compare the time to develop a
foot ulcer by treatment group. We used
three statistical tests to examine whether
the three treatments were different. First,
an overall test was done. Then we used a
pairwise comparison, and nally a test for
trend was performed. We used the log-
rank test, provided in SPSS 10 in the anal-
ysis. We used the Pearson
2
statistic
based on the cell counts of ulcer status
versus treatment (standard therapy, struc-
tured foot examination, and enhanced
therapy) to evaluate the effect of the inter-
ventions on incident foot ulceration.
RESULTS All of the study partici-
pants had a history of a foot wound and
sensory neuropathy with loss of protec-
tive sensation. There were no signicant
differences in age, duration of diabetes,
history of partial foot amputation, sever-
ity of sensory neuropathy, or activity level
among the three treatment groups. De-
scriptive characteristics of this population
are detailed in Table 1. Data are reported
as means SD.
A Kaplan-Meier survival analysis was
performed to evaluate the time to ulcerate
by treatment group (Fig. 2). Subjects were
censored when an ulcer developed or if
they left the study for other reasons. There
was a statistically signicant overall differ-
ence between the times to develop ulcers
by treatment groups using the log-rank
test (P 0.011). Simultaneous pairwise
comparisons using the log-rank test
showed no difference between standard
therapy and structured foot examination
(P 0.910). However, enhanced therapy
was signicantly different fromboth stan-
dard therapy (P 0.0059) and structured
foot examination (P 0.0055). From the
test for trend, there was a statistically sig-
nicant trend of survival with the en-
hanced therapy being superior over the
standard therapy or structured foot exam-
ination (P 0.0107).
The incidence of foot ulceration dur-
ing the 15-month evaluation period was
essentially identical in the standard ther-
apy (29.3%) and structured foot exami-
nation (30.4%) treatment arms. There
was a 4-fold decrease in the risk of de-
veloping foot ulceration in subjects in the
enhanced therapy group (8.5%) com-
pared with the standard therapy group
(OR 4.48[95% CI 1.5313.14], P
0.008) and structured foot examination
group (4.71 [1.6013.85], P 0.0061).
Not surprisingly, adherence to pre-
vention practices was a pivotal factor in
ulcer prevention. In the enhanced ther-
apy group, patients who were compliant
with recording foot temperatures at least
50% of the time were signicantly less
likely to develop a foot ulcer (OR 50.0,
P 0.001). Of patients in the enhanced
therapy group who developed foot ulcers,
80%did not comply with temperature as-
sessment. However, of patients who did
not develop an ulcer in the enhanced
therapy group, 92% recorded their foot
temperatures at least half the time.
Among patients in the structured foot ex-
amination group, there was no difference
in compliance with recording daily foot
inspections in patients who developed ul-
cers (47.1%) and those who did not
(43.6%; P 0.81).
In addition, self-reported adherence
with wearing therapeutic shoes and in-
soles was high in all three treatment arms
(Table 1). There was no signicant differ-
ence in subjects who wore therapeutic
shoes and insoles at least 8 h/day among
treatment groups (standard therapy
89.5%, enhanced therapy 83.0%, and
structured foot examination 73.2%; P
0.071) (Table 1)
Enhanced therapy patients used the
temperature monitoring device as a trig-
ger to contact the study nurse, and they
identied areas of concern more fre-
quently than patients in other treatments
arms who relied on visual signs. Signi-
cantly more patients in the enhanced
therapy group contacted the study nurse
for concerns of foot problems than pa-
tients in the standard therapy (P 0.030)
or structured foot examination groups
(P 0.026) (Table 2). Thirty-one sub-
jects in the enhanced therapy group con-
tacted the study nurse. In addition, 7
more patients did not contact the study
Preventing diabetic foot ulcer recurrence
16 DIABETES CARE, VOLUME 30, NUMBER 1, JANUARY 2007
nurse when they observed elevated foot
temperatures but decreased their activity
based on pedometer activity data. When
we compared the number of steps per day
for the 3 days before and 3 days after an
elevated temperature was identied, on
average, there was a 51.2% decrease in
activity, representing an average reduc-
tion of 1,725 1,784 steps/day.
Based on inspection of their feet, sub-
jects in the structured foot examination
group contacted the study nurse 18 times,
and subjects in the standard therapy
group contacted the study nurse 17 times.
However, by the time patients in the stan-
Table 1Patient characteristics
Subject population Standard therapy Enhanced therapy
Structured foot
examination
n 58 59 56
Age (years) 65.0 9.6 (4180) 65.4 9.3 (4280) 64.2 8.6 (4080)
Sex (% male) 53.4 55.9 51.7
Race
Non-Hispanic white 31 (53.4) 32 (54.2) 31 (55)
Mexican American 24 (41.4) 22 (37.3) 25 (45)
African American 3 (5.2) 3 (5.1) 2 (4)
Type 2 diabetes 56 (97) 55 (93) 53 (95)
Duration of diabetes (years) 13.7 10.3 (222) 12.7 9.7 (425) 13.8 11.5 (531)
Diabetes medication
Oral 31 (53.4) 32 (54.2) 30 (53.6)
Insulin 13 (22.4) 15 (25.4) 10 (17.9)
Combination 10 (17.2) 11 (18.6) 12 (21.4)
Diet 4 (6.9) 1 (1.7) 4 (7.1)
Ulcer history and locations
Hallux 7 (12.1) 4 (6.8) 8 (14.3)
Toes 29 (50.0) 35 (59.4) 30 (53.5)
Submetatarsal 21 (36.2) 17 (28.8) 21 (37.5)
Midfoot to heel 3 (5.1) 7 (11.9) 5 (8.9)
Patients with a history of previous amputation 18 (31.0) 13 (22.0) 14 (25.0)
Amputation sites
Toe 12 (20.7) 11 (18.6) 12 (21.4)
Toe and metatarsal 8 (13.8) 4 (6.8) 4 (7.1)
Midfoot 0 2 (3.4) 2 (3.6)
History of vascular surgery
Lower extremity bypass 3 (5.2) 0 0
Lower extremity angioplasty 0 0 1 (1.8)
Coronary artery bypass surgery 2 (3.4) 1 (1.7) 0
Cardiac angioplasty 0 0 2 (3.6)
Lower extremity examination
Neuropathy evaluation
Semmes-Weinstein 10-g monolament right 5.2 4.8 5.3 4.7 5.2 4.7
Semmes-Weinstein 10-g monolament left 4.7 4.3 4.7 4.3 4.7 4.3
Vibration perception threshold right 41.8 9.8 (1450) 40.6 9.6 (1250) 40.6 8.6 (1450)
Vibration perception threshold left 39.3 8.6 (1250) 38.6 8.1 (1150) 39.0 8.0 (1250)
Foot deformity
Hallux rigidus 50 (86.2) 51 (86.4) 46 (82.1)
Hallux valgus 23 (39.0) 33 (55.0) 12 (21.0)
Claw toe/hammer toe 33 (56.0) 41 (69.0) 41 (73.0)
Vascular examination
Ankle-brachial index right 1.1 0.4 (0.71.5) 1.1 0.4 (0.71.5) 1.1 0.6 (0.82.0)
Ankle-brachial index left 1.2 0.5 (0.71.7) 1.1 0.6 (0.71.9) 1.2 0.6 (0.71.9)
Activity (steps per day) 3,817 3,364 3,489 2,706 3,963 2,363
Footwear compliance
Time prescribed shoes were worn (h)
4 1 (1.7) 2 (3.4) 0
48 5 (8.6) 8 (13.6) 15 (26.8)
812 33 (56.9) 31 (52.5) 19 (33.9)
12 19 (32.6) 18 (30.5) 22 (39.3)
Data are means SD (range) or n (%).
Lavery and Associates
DIABETES CARE, VOLUME 30, NUMBER 1, JANUARY 2007 17
dard therapy and structured foot exami-
nation groups contacted the study nurse,
usually a foot ulceration had already de-
veloped (structured therapy group
94.4%; structured foot examination
group 100%).
CONCLUSIONS Speci al ty di a-
betic foot clinics have been shown to re-
duce the incidence of ulceration and
amput at i on i n hi gh-ri sk pat i ent s
(2,28,29). Often these foot clinics provide
protective shoes and insoles, foot-specic
education, and advanced clinical care.
These clinics usually deliver services that
are well above the local community stan-
dard. However, even in specialty foot
clinics, recurrence of diabetic foot ulcers
is often very high, generally ranging from
25 to 80% per annum (3033). In ideal
circumstances, high-risk patients can
only be evaluated in specialty clinics four
to six times a year. Patients and their fam-
ilies must bridge the gap between exami-
nations. Therefore, self-monitoring to
identify areas on the foot that are injured
is critical to prevent ulceration and lower
extremity amputation.
Self-care may be the single most im-
portant factor in preventing complica-
tions in individuals with a high risk for
diabetic foot ulceration (3436). Patients
and their families must be able to monitor
the lower extremities to identify signs of
disease and precursors to injury. The
medical community has, to date, failed to
provide any practical, efcacious tool to
help in this process. At most, clinicians
encourage self-inspection and occasion-
ally suggest that patients use a mirror to
evaluate the bottom of the foot. Unfortu-
nately, many diabetic patients with a high
risk for ulceration cannot see their feet
because of obesity, limited joint mobility,
or visual impairment (37). As demon-
strated in this study, most of the time,
self-inspection skills are not effective in
identifying the subtle precursors to ulcer-
ation. By the time patients in this study
were able to visualize areas of concern, it
was too late, and an ulceration had al-
ready developed. The results of this study
surprisingly suggested that structured
self-inspection with the aid of a mirror
provided no overt risk reduction com-
pared with general diabetic foot educa-
tion. The incidence of foot ulceration in
the standard therapy and structured foot
examination groups was similar to that in
studies using standard prevention
practices as described in this project
(2,31,33).
The intervention in this study, namely
home temperature monitoring, proved to
be an effective approach to provide objec-
tive feedback, sopatients couldmodifytheir
activity and protect their foot before ulcer-
ation developed. The majority of study
subjects were able to use the device as an
early warning system and reduce their ac-
tivity until temperatures normalized. En-
hanced therapy pati ents used the
temperature device to identify abnormal-
ities more often than the other groups
(standard therapy and structured foot
examination patients) could by visual in-
spection or palpation alone. Overall, 88%
of patients in the enhanced therapy group
recorded their temperatures 50%of the
time during the 15-month study period.
Patients who developed ulcers did not
comply with measuring their foot temper-
atures; four of ve (80%) subjects who
were assigned to use the temperature de-
vice and developed ulcerations did not
Figure 2Kaplan-Meier survival analysis of time to ulceration by treatment group. Kaplan-
Meier survival analysis demonstrated a signicantly longer time to ulcerate in the enhanced
therapy group compared with the structured foot examination and standard therapy groups. The
mean time to ulcerate was 429.5 11.9 in the enhanced therapy group, 377.3 18.4 in the
structured foot examination group, and 378.5 18.6 in the standard therapy group.
Table 2Clinical outcomes, adverse events, and voluntary withdrawals
Outcomes
Standard
therapy
Enhanced
therapy
Structured foot
examination
n 58 59 56
Patients who contacted study nurse
after self-examination
18 (31.0) 31 (52.5) 17 (30.4)
Foot ulceration 17 (29.3) 5 (8.5) 17 (30.4)
Withdrawal from study because of
adverse events
Foot trauma 1 (1.7) 1 (1.7) 0
Fracture 0 1 (1.7) 2 (3.6)
Death 2 (3.4) 1 (1.7) 0
Osteomyelitis: no ulcer 0 0 1 (1.8)
Motor vehicle accident 0 0 1 (1.8)
Myocardial infarction 0 1 (1.7) 0
Voluntary withdrawal from study
Too much to do 2 (3.4) 6 (10.2) 2 (3.6)
Moved out of town 1 (1.7) 0 0
Data are n (%).
Preventing diabetic foot ulcer recurrence
18 DIABETES CARE, VOLUME 30, NUMBER 1, JANUARY 2007
adhere to their prescribed assessment
regimen.
This study was successful in amal-
gamating observations from previous
studies and putting them in the hands of
high-risk subjects in the form of a simple,
easy to use device. The vast majority of
participants were able to comply with in-
structions and subsequently prevent foot
ulcerations. The rates of compliance with
this program seemed to be much higher
than those for home blood glucose mon-
itoring, for which the prevalence of non-
compliance can be as high as two-thirds
(38,39). Thus, the results of this study
suggest that equipping individuals with
diabetes at highest risk for foot ulceration
with simple skin temperature devices may
signicantly reduce the risk for foot ul-
cers. In fact, just as with comprehensive
general programs aimed to facilitate good
glucose control (40), a regimen incorpo-
rating home temperature monitoring may
allow individuals to monitor their dose
of activity by checking their skin temper-
atures just as they might monitor their
dose of insulin by checking their glucose.
It seems likely that the cost benet of
home temperature monitoring might be
much better than that for using glucose
strips for home monitoring. In addition, a
tool to adjust activity could help with the
dilemma of exercising for better health
versus the need to rest and protect the
foot to avoid foot ulcers.
Acknowledgments This project was sup-
ported by Grant R44DK54559 from the Na-
tional Institute of Diabetes and Digestive and
Kidney Diseases, National Institutes of Health.
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