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Diabetic Foot Ulcer Off-loading: The GapBetween Evidence and Practice. Data
from the US Wound RegistryCaroline E. Fife, MD; Marissa J. Carter, PhD; David Walker, CHT;
Brett Thomson, MS; and Kristen A. Eckert, MPhil
ABSTRACTOBJECTIVE: To evaluate the practice of off-loading diabetic foot
ulcers (DFUs) using real-world data from a large wound registry to
better identify and understand the gap between evidence and practice.
DESIGN: Retrospective, deidentified data were extracted from the
US Wound Registry based on patient/wound characteristics,
procedures performed, and at which clinic the DFU was treated.
SETTING: 96 clinics (23 from the United States and Puerto Rico).
PATIENTS: 11,784 patients; 25,114 DFUs.
MAIN OUTCOME MEASURES: Healed/not healed, amputated, percent
off-loading, percent use of total contact casting (TCC), infection rate.
MAIN RESULTS: Off-loading was documented in only 2.2% of
221,192 visits from January 2, 2007, to January 6, 2013. The most
common off-loading option was the postoperative shoe (36.8%)
and TCC (16.0%). There were significantly more amputations
within 1 year for non-TCCYtreated DFUs compared with TCC-treated
DFUs (5.2% vs 2.2%; P = .001). The proportion of healed wounds
was slightly higher for TCC-treated DFUs versus non-TCCYtreated DFUs
(39.4% vs 37.2%). Infection rates were significantly higher for
non-TCCYtreated DFUs compared with TCC-treated DFUs (2.6 vs 1.6;
P = 2.1 � 10j10). Only 59 clinics used TCC (61%); 57% of those
clinics used traditional TCC, followed by TCC-EZ (36%). Among clinics
using any type of TCC, 96.3% of the DFUs that did not receive
TCC were ‘‘TCC-eligible’’ ulcers. Among clinics using ‘‘traditional’’
TCC systems, 1.4% of DFUs were treated with TCC, whereas clinics
using TCC-EZ provided TCC to 6.2% of DFUs.
CONCLUSION: Total contact casting is vastly underutilized in DFU
wound care settings, suggesting that there is a gap in practice for
adequate off-loading. New, easier-to-apply TCC kits, such as the
TCC-EZ, may increase the frequency with which this ideal form
of adequate off-loading is utilized.
KEYWORDS: diabetic foot ulcer, off-loading, electronic health records
ADV SKIN WOUND CARE 2014;27:310Y6
INTRODUCTIONDiabetic foot ulcers (DFUs) are a potentially deadly and costly
complication of diabetes. Comprehensive wound management
is necessary for DFU care to heal and avoid amputation.1Y3 The
current standard of care for DFUs involves a comprehensive pa-
tient and wound assessment, the management of vascular disease,
infection control, debridement, moist wound care, and the off-
loading of pressure. Even with optimal management of all other
factors, DFU healing is unlikely in the absence of adequate pres-
sure relief, making off-loading an essential part of DFU man-
agement supported by at least a moderate level of evidence.1Y3
Total contact casting (TCC) is considered the ‘‘presumptive’’ cri-
terion standard of care of off-loading.4Y6 This has been reconfirmed
by a recent Cochrane Review,7 which concluded that nonremovable
casts are the most effective off-loading devices for DFUs. ‘‘Tra-
ditional’’ TCC, however, typically has been found to be a complex,
technically difficult, and time-consuming procedure for the average
wound care clinic, although the application of a TCC is a reim-
bursable procedure under Medicare. Studies suggest that most
wound care practitioners neither use TCC nor perform adequate off-
loading, and off-loading, in general, is not commonly practiced.8Y10
The gap between the moderate level of evidence supporting the
efficacy of off-loading in controlled clinical trials and its use in clinical
practice (real-world practice) warrants further investigation. Conse-
quently, the authors developed the current pilot study to explore how
off-loading is implemented in the real-world wound care setting.
The objective of this study was to evaluate the practice of off-loading
DFUs in the clinical care setting using real-world data from a large
wound registry to more clearly identify the gap between evidence
and practice. Because the authors did not know in advance whether
they would have a large enough sample size or be able to identify all
the covariates that could influence wound healing when TCC is used
or indeed have relatively complete data for covariates, they planned
a simple data analysis rather than an ad hoc multivariate analysis.
ADVANCES IN SKIN & WOUND CARE & VOL. 27 NO. 7 310 WWW.WOUNDCAREJOURNAL.COM
ORIGINAL INVESTIGATION
Caroline E. Fife, MD, is Executive Director, US Wound Registry; Chief Medical Officer, Intellicure, Inc; and Medical Director, St Luke’s Wound Center, The Woodlands, Texas. Marissa J.
Carter, PhD, is President, StrategicSolutions, Inc, Cody,Wyoming.DavidWalker, CHT, is President andChief ExecutiveOfficer, Intellicure, Inc, TheWoodlands, Texas.Brett Thomson,MS, is Chief
InformationOfficer, Intellicure, Inc, TheWoodlands, Texas.KristenA. Eckert,MPhil, isConsultant/SeniorWriter/Editor,StrategicSolutions, Inc,Cody,Wyoming.DrFife,MrWalker, andMrThomson
have disclosed that Intellicure, Inc, received grant monies from Derma Sciences Inc related to this article. Dr Carter has disclosed that Strategic Solutions, Inc, is/was a consultant/advisor for
Intellicure, Inc;wasaconsultant forDermaSciences Inc; is/was the recipientof payment formanuscripts forDermaSciences Inc; andDrCarter is amember of the speakers’ bureau for theAmerican
Professional Wound Care Association. Ms Eckert has disclosed she received payment from Strategic Solutions, Inc, for the writing of this manuscript. This project was financially supported by
Derma Sciences Inc. Submitted December 17, 2013; accepted in revised form April 14, 2014.
Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
METHODSStudy EligibilityAll patients who had visited the clinic more than 1 time for a
new DFU were eligible to be included in the study. No exclusion
was made in regard to Wagner grade, wound severity, or patient
comorbidity.
Settings and Database DescriptionData were contributed by clinics participating in the Intellicure Re-
search Consortium, a national clinical data research network (CDRN)
of hospital-based outpatient wound centers across the United States
and Puerto Rico that agree to share deidentified data from patient
electronic health records (EHRs) in exchange for benchmarking
services. Clinics utilizing the Intellicure EHR sign a data use agree-
ment that allows all the clinical information contained in the EHRs
of all patients to be Health Insurance Portability and Accountability
Act (HIPAA) deidentified and moved on to servers operated by
the US Wound Registry (USWR). The USWR provides quality re-
porting services to the Centers for Medicare & Medicaid Services
(CMS) on behalf of physicians participating in the Physician Qual-
ity Reporting System (PQRS), as well as data for clinical bench-
marking for facilities. Key benchmarks, such as healing rates,
compression of venous ulcers, off-loading of DFUs, amputation
rates, and more than 50 other quality and outcome indicators are
available for each clinic to view their own results in comparison with
the deidentified aggregate.
The clinics utilized a specialty-specific EHR certified to meet the
recent Health Information Technology for Economic and Clinical
Health Act standards,12 which has achieved an unusually high de-
gree of structured language programming, facilitating data acqui-
sition and analysis. Intellitrack (Intellicure, Inc, The Woodlands,
Texas) is an EHR specifically designed for the documentation needs
of wound centers and wound care physicians. It archives photo-
graphs; internally calculates complex billing functions, such as de-
bridement codes and cellular- and tissue-based product application
codes; tracks wound size and volume changes, and wound out-
comes. It is used by approximately 100 hospital-based outpatient
clinics specifically to document the patient-care functions provided
in wound and hyperbaric centers. The pooled, deidentified records
from clinics participating in the CDRN were analyzed for this study.11
The USWR Independent Institutional Review Board (The Wood-
lands IRB) approved this study and determined that retrospective
analysis of HIPAA-compliant data, as described here, was exempt
from the requirement for patient consent.
Data ExtractionThe USWR was queried using Microsoft’s SQL programmable
relational database management system (Microsoft, Redmond,
Washington) to provide specific data sets. The term queryhere refers
to use of program commands to delineate specific sets of variables
associated with visits to a clinic related to a patient, ulcer, or the visit
itself (eg, male patients with DFUs of Wagner grade 1 or 2 with
visits from January 1, 2009, to December 31, 2011). Data sets are
constructed at the ‘‘patient level’’ (eg, patient characteristics, such
as age in years), the ‘‘problem level’’ (eg, ulcer characteristics, such
as duration of ulcer in days at first visit), and the ‘‘visit level’’
(eg, characteristics associated with ulcers or patients at a given
visit, such as the surface area in centimeters squared of a DFU
at that visit).
Data on independent variables were collected as follows: (1) pa-
tient related: age, gender, race, insurance type, and wound care
center at which the DFU was treated; (2) ulcer related: Wagner
grade, surface area, and exposed tissue type at each clinic visit (eg,
bone, tendon, subcutaneous tissue); (3) procedure related: whether
off-loading of the DFU was documented and, if so, what type of
off-loading was ordered.
Within the EHR, because there is no unique International Classi-
fication ofDiseases,NinthRevision,ClinicalModification code for DFUs,
diabetic ulcers are identified as chronic ulcers ‘‘related to’’ the un-
derlying disease of diabetes. Thus, the mere presence of diabetes
in a patient with a leg ulcer did not constitute a diagnosis of a DFU.
Specific body location was identified using ‘‘free text’’ entries (eg,
‘‘left first metatarsal head’’). The EHR internally audits the chart to
calculate both the physician and the facility (hospital) level-of-
service charge. The charges for procedures such as TCC are directly
transmitted to the hospital billing software from the wound center
EHR. Both physicians and nurses perform point-of-care documen-
tation in the examination room with the patient. Thus, documen-
tation of TCC, if performed, was required for the facility to bill the
application of the cast and would have been documented at the
time of casting. As TCC must be documented within the EHR for
reimbursement to be obtained, if TCC was performed, it was highly
likely to be documented. No similar monetary ‘‘incentive’’ exists to
document other forms of DFU off-loading, such as shoe modi-
fication or custom orthotics. However, documentation of these
other off-loading options is facilitated by the presence of ‘‘drop-
down’’ menus from which clinicians can easily select the off-loading
method in use.
Types of off-loading were categorized as follows: TCC, post-
operative shoe (standard brand provided by hospital after foot
surgery [Figure 1]), shoe modification (meaning, the patient’s own
shoe often with a hole cut to relieve pressure), half shoe, custom
insert, DH walker (Royce Medical, Camarillo, California, also known
as the ‘‘Active Off-loading Walker’’), CROW (‘‘Charcot Restraint
Orthotic Walker,’’ usually custom fabricated [Figure 2]), or ‘‘other’’
in case none of the previous classifications applied. Categories of
TCC were further elaborated as follows: ‘‘traditional’’ TCC (using
traditional plaster casting materials), MedE-Kast (Derma Sciences
ADVANCES IN SKIN & WOUND CARE & JULY 2014311WWW.WOUNDCAREJOURNAL.COM
ORIGINAL INVESTIGATION
Copyright © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Inc, Princeton, New Jersey), and TCC-EZ (Derma Sciences Inc
[Figure 3]). The TCC-EZ offers a 1-piece, roll-on, woven design
that simplifies the casting process by eliminating the need to apply
multiple rolls of fiberglass and plaster, which can reduce the po-
tential for errors and the staff time needed to apply TCC (Figures 4Y6).
(Note: These images are from a copyrighted video, and an actor
was used; no real patient was used.)
A TCC-eligible DFU was defined as a DFU that fell within the
same range of surface area, type of tissue exposed, and Wagner
grade as the DFUs treated by TCC. Thus, DFUs representing all
Wagner grades and levels of tissues with areas up to 137.1 cm2
were eligible for TCC in this study. The point of these criteria was
to establish a range of wound parameters that were found in TCC-
treated wounds, so the authors could identify which non-TCCY
treated DFUs could have been treated with TCC.
Outcomes were defined as healed, not healed (improving, no
change, or worsening), or amputated. Exposed tissue type was
categorized as follows: partial thickness or full thickness specified
as subcutaneous tissue, fat, tendon, muscle, bone, or undefined.
The following surrogates of infection were also collected for the
development of a surrogate infection variable: wound culture taken,
antibiotics prescribed, wound drainage (green, malodorous, or
purulent), periwound characteristics noted to be erythematous,
and patient temperature noted to be higher than a specified tem-
perature. Although these factors can be summed for a composite
score at any given visit,13 they were summed up over the time to
outcome. Given the fact that the use of wound biopsies in practice
to diagnose localized wound infection does not occur in every in-
stance, the authors wanted to develop a strategy to capture as many
possible infection episodes and thus used this number as a sur-
rogate for possible episodes of infection or bioburden.
Figure 1.
A NEW POSTOPERATIVE SHOE (LEFT) AND A USED
POSTOPERATIVE SHOE THAT HAS ALREADY
BEENWORN BY A PATIENT (RIGHT)
Courtesy of Caroline E. Fife, MD, clinical photos
Figure 2.
CROW (CHARCOT RESTRAINT ORTHOTIC WALKER)
Courtesy of Caroline E. Fife, MD, clinical photos
Figure 3.
THE TCC-EZ ROLL-ON CAST
Image/Courtesy of Derma Sciences Inc
ADVANCES IN SKIN & WOUND CARE & VOL. 27 NO. 7 312 WWW.WOUNDCAREJOURNAL.COM
ORIGINAL INVESTIGATION
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Statistical AnalysisCategorical variables were described using frequencies and per-
centages; continuous variables were described using range, mean,
and SD if normal, and range and median if nonnormal. If sta-
tistical testing by group or other factors was conducted,W2 or Fisher
exact test was used for discrete variables, and t tests or Mann-
Whitney U tests were used for normally distributed variables or
nonnormal/Poisson distributions, respectively. Time to events was
calculated using Kaplan-Meier, with differences tested using the
log-rank test.
An > of .05 was considered statistically significant. All statistical
analyses were conducted using IBM SPSS Statistics 19.0 (IBM,
Chicago, Illinois) using 2-tailed tests.
RESULTSDemographicsA total of 11,784 patients with 25,114 DFUs were seen at 96
clinics in 157,802 unique visits or 221,192 visits in which ulcers
received care per visit (eg, a single patient with 2 DFUs would
have 2 ‘‘ulcer visits’’ on a given clinical encounter) from January 2,
2007, to January 6, 2013. Although data were obtained from a total
of 23 different states, geographically, the 5 states contributing
the largest volume of data were Texas (30.3%), New York (10.9%),
Georgia (9.7%), Mississippi (7.9%), Utah (6.2%), and Florida (5.0%).
The mean age of patients at their first clinic visit was 63.9 (SD,
13.55) years (range, 1Y105 years; 5 patients were G18 years old),
with the population comprising 61.2% males and 38.8% females.
Most patients were white (62.5%), followed by Hispanic (13.0%),
African American (12.8%), Native American Indian (1.0%), Asian
(0.9%), East Indian (0.2%), and Arabic (0.3%); 2.6% were of other
races, and 6.7% of patients had no race documented. Slightly more
than half of the patients were Medicare beneficiaries (50.4%), with
other payers including commercial insurance (34.2%), Medicaid
(5.0%), worker’s compensation (0.2%), or self-pay (1.4%). The re-
mainder did not have insurance recorded.
Off-loading of DFUsOff-loading was documented in only 2.2% of DFU visits (the de-
nominator for this calculation is 221,192 visits). The most common
treatment documented was a postoperative shoe (36.8%) followed
by TCC (Table 1). The majority of DFUs receiving TCC were
Figure 5.
TCC-EZ APPLICATION DOES NOT REQUIRE MULTIPLE
LAYERS OF PLASTER AND FIBERGLASS THAT ARE
REQUIRED FOR THE APPLICATION OF TRADITIONAL TCC
Image/Courtesy of Derma Sciences Inc
Figure 6.
A PATIENT FOLLOWING THE COMPLETE APPLICATION
OF TCC-EZ
Image/Courtesy of Derma Sciences Inc
Figure 4.
THE TCC-EZ CAST SOCK IS ROLLED ON TO THE
PATIENT’S AFFECTED FOOT
Image/Courtesy of Derma Sciences Inc
ADVANCES IN SKIN & WOUND CARE & JULY 2014313WWW.WOUNDCAREJOURNAL.COM
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Wagner 1 (58.3%), followed by Wagner 3 (21.7%), Wagner 2 (19.2%),
Wagner 4 (0.4%), and Wagner 5 (0.2%). Likewise, the level of
tissue exposed at each visit for TCC-treated DFUs was most
commonly full thickness at the level of subcutaneous tissue
(53.6%), followed by partial thickness (13.7%), although it was
undefined in 15.5% of DFUs. The mean maximum wound surface
area for TCC-treated DFUs was 3.5 (SD, 8.45) cm2, with a median
of 1.05 cm2 and a range of 0.01 to 137.3 cm2 (non-TCCYtreated
DFUs, mean maximum wound area: 3.9 [SD, 9.34] cm2).
Usage of TCCOnly 59 clinics ever used TCC (61%), with 57% of those TCC-
using clinics using traditional TCC, followed by TCC-EZ (36%),
plaster/fiber (5%), and MedE-Kast (1%). Looking at the type of
TCC used by visit, the most utilized was traditional (65.1%), fol-
lowed by TCC-EZ (29.8%), plaster/fiber (4.9%), and MedE-Kast
(0.1%). Among clinics using TCC, applying the criteria defined in
the Methods section for a ‘‘TCC-eligible’’ DFU, of the DFUs that
were eligible for TCC, only 3.7% received it. Applying the same
criteria to all clinics, 96.4% of DFUs that did not receive TCC would
have been eligible. Among clinics using plaster/fiber systems, MedE-
Kast, and traditional TCC systems, only 1.4% of DFUs were treated
with TCC. In contrast, clinics using TCC-EZ provided TCC to 6.2%
of DFUs.
Outcomes (TCC vs Non-TCC Treatment)Although the proportion of healed wounds at 1 year was only
slightly higher for TCC-treated DFUs compared with non-TCCY
treated DFUs (39.4% vs 37.2%; not significant), there were signi-
ficantly more amputations within 1 year for the non-TCCYtreated
group compared with the TCC-treated group (5.2% vs 2.2%; P =
.001). Moreover, the time to amputation was significantly shorter for
the non-TCCYtreated group (317 vs 351 days; P = 2.8 � 10j11).
InfectionThe mean surrogate the authors created for ‘‘infection/bioburden
count’’ during the length of treatment by 1 year was significantly
higher for the non-TCCYtreated group compared with the TCC-
treated group (2.6 vs 1.6 [SD, 3.31] vs 4.85; P = 2.1 � 10j10). For
the entire set of TCC-treated DFUs (count not truncated to 1 year
to maximize sample size), however, the mean infection count for
the TCC-EZ group was significantly less compared with other
types of TCC (2.7 vs 3.3 [SD, 5.65] vs 6.64; P = .003). No attempt
was made to control for Wagner grade or patient comorbid con-
ditions in these analyses.
DISCUSSIONThe results of this preliminary study support previous evidence8Y10,14
that, despite the efficacy of TCC as demonstrated by improved
healing outcomes, there exists a gap in practice for off-loading DFUs.
It is possible that poor documentation practices within the EHR
contributed to an apparently low rate of DFU off-loading. It is im-
portant to note that TCC is applied in the clinic and thus must be
documented in the EHR if charges for this procedure are sub-
mitted. Other types of DFU pressure-reducing footwear that may
be used by the patient are not actually applied by the wound care
clinician at the time of service (eg, CROW, which must be
fabricated, usually by an orthotist). Thus, documentation of their
use is dependent on individual clinician motivation for charting
completeness. The result is that the authors’ data likely provide an
accurate representation of TCC utilization but may underrep-
resent non-TCC off-loading options. Despite this, postoperative
shoes are the most frequently documented method for ‘‘off-
loading’’ DFUs.
Off-loading was reported in only 2.2% of the total 221,192 visits.
Just as alarming, TCC use was documented in only 16.0% of the
DFU visits that had off-loading reported. Among those clinics using
TCC, an astounding 96.3% DFUs were eligible for TCC but did not
receive it, indicating that TCC is vastly underutilized even within
facilities familiar with the technique. In the authors’ previous re-
trospective study of the USWR,10 they assessed 108,000 patient visits
in 18 wound centers in 16 states and found that only 6% of pa-
tients with DFUs were treated with TCC. The current study pro-
vides a more thorough examination of off-loading practices in a
larger number of clinics over a longer period. These data indicate
that off-loading in general and TCC in particular are utilized even
less frequently than the authors previously reported. Most visits
by patients with DFUs had no off-loading documented. This is not
surprising as, in the absence of a quality measure within a
program such as the PQRS, there is little incentive to document
the use of off-loading that is not actually performed by the wound
care clinician. When off-loading was documented (only 2.2% of
visits), the most commonly documented type (the removable
Table 1.
TYPES OF OFF-LOADING USED AT THE 2.2%OF VISITS THAT HAD OFF-LOADINGDOCUMENTED
Option Visit Count %
Postoperative shoe 1803 36.8TCC 781 16.0Shoe modification 652 13.3DH walker 469 9.6Half shoe 266 5.4Custom insert 259 5.3CROW 174 3.6Othera 492 10.0Total 4896 100
aMost were multiple combinations of the major types listed.
ADVANCES IN SKIN & WOUND CARE & VOL. 27 NO. 7 314 WWW.WOUNDCAREJOURNAL.COM
ORIGINAL INVESTIGATION
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postoperative shoe) has no evidence base to support its efficacy.
In fact, postoperative shoes and shoe modifications have re-
peatedly been shown to be inadequate and insufficient methods
to facilitate DFU healing.5,7,8,15Y17 Therefore, not only is off-loading
poorly implemented in wound care, but also the preferred method
of off-loading used by most practitioners is the least effective.
The results of this pilot study suggest that TCC might have a
therapeutic benefit in preventing amputations. At 1 year, there
were significantly fewer amputations for the TCC-treated group
compared with the non-TCCYtreated group (2.2% vs 5.2%;P= .001)
and a significantly longer time to amputation (351 vs 317 days; P =
2.8 � 10j11). Although a larger study is needed to confirm this
result, if TCC does help prevent or delay amputations among the
patients commonly seen in wound centers, this finding would be
an enormous cost-effectiveness argument for its use. Although the
Cochrane review7 on the subject did not review amputations as an
outcome, it did report on complete wound healing at 12 weeks
and found through fixed effects meta-analysis a relative risk (RR)
of 1.17 (95% confidence interval, 1.01Y1.36). These results are only
slightly better than the authors’ results (RR, 1.06), most likely be-
cause the patients in their study had more comorbidities and more
severe wounds and took much longer to heal. Finally, the data for
the Cochrane analysis come from 5 small clinical trials, which en-
gender considerable uncertainty regarding the long-term outcome
of the patients.
It is not clear from the authors’ preliminary data whether the
various types of TCC they identified produce substantially dif-
ferent DFU healing outcomes. The authors’ data suggest that the
mean time to outcome (healing, amputation, and so on) was slightly
lower for DFUs treated with TCC-EZ compared with other types
of TCC (mean, 167.5 vs 172.2 days), although these differences
were not statistically significant and probably not clinically mean-
ingful. However, the incidence of infection and bioburden was
slightly higher for those DFUs treated with other types of TCC
compared with TCC-EZ (3.3 vs 2.7; P = .003). This suggests that
patients undergoing treatment with TCC-EZ may be less likely
to experience infection or excess bioburden; however, the mea-
sures used should be considered only as proxies for the diagnosis
of infection.
Total contact casting is widely considered a technically difficult
and time-consuming procedure that requires training to properly
apply and generates low reimbursement compared with the direct
and indirect costs associated with its use (eg, cast saw, materials,
staff time). Thus, despite its proven track record, barriers to adop-
tion are hard to overcome, particularly when other DFU treatments
are easier to utilize and have a better profit margin.7,8,10 Moreover,
TCC is also considered a greater inconvenience to the patient, re-
sulting in reduced mobility, difficulty sleeping, and restrictions in
bathing,7 all of which contribute to at least a perceived patient pre-
ference for removable off-loading options (or none at all).
The authors’ previous work suggests that adoption of TCC
would be improved by making the process easier to perform.10
Thus, more efficient ‘‘kits’’ or the removal of institutional barriers
regarding procurement of TCC supplies is likely to improve usage.
There are new, easier-to-apply, and faster techniques that may
increase the use of adequate off-loading, which are reported to be
as effective as traditional TCC.5,15Y20 These include the instant TCC,
which is a removable cast walker rendered irremovable when
wrapped in a cohesive or plaster bandage.18 Another option is the
TCC-EZ roll-on cast. In fact, the authors found that DFUs were far
more likely to undergo off-loading with TCC among clinics using
the TCC-EZ than other methods of TCC (1.4% in clinics with
other TCC options compared with 6.2% with TCC-EZ). A further
consideration to the more common use of TCC-EZ in this study,
compared with other methods, is that TCC-EZ was not widely
available before late 2008. These preliminary data appear to sup-
port the assertion that decreasing the complexity of TCC appli-
cation may increase the use of adequate off-loading.
Although the main barriers to TCC use are logistical (based on
the skill set and training required, the ongoing learning curve, the
application time, and the supplies and procurement process), reim-
bursement is still an important issue. The current volume-based
structure of outpatient payment rewards inefficient care and pro-
vides no feedback mechanism for quality. In fact, it could be argued
that under the current system, clinicians have a perverse disincentive
to heal DFUs quickly and at a lower cost. The answer would seem
to lie in the development of quality measures that are focused on
best practices such as off-loading.8 Despite the fact that there are
some quality measures relevant to the inspection of diabetic foot-
wear for ulcer prevention or assessing diabetics for peripheral neu-
ropathy, surprisingly there is no quality measure within any CMS
program (such as the PQRS) that addresses the management of
an existing DFU.7,17,21
CONCLUSIONSDeidentified data from EHRs are currently used to estimate the
magnitude of a problem, assess service delivery, document the
types of patients served by providers, observe the progression of a
disease, understand treatment and outcome variations, and deter-
mine the clinical, cost, and/or comparative effectiveness of an
intervention.10 Despite the fact that off-loading is universally rec-
ommended to reduce the pressure and strain rate on a DFU,1Y3 the
authors’ study confirms that the practice of off-loading remains
underutilized in the wound care setting. Thus, the USWR has proved
useful in demonstrating a serious gap between evidence and prac-
tice in the management of DFUs.
ADVANCES IN SKIN & WOUND CARE & JULY 2014315WWW.WOUNDCAREJOURNAL.COM
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An advantage of the authors’ study was that data were taken
directly from a highly structured EHR. Limitations of the study
included a selection bias in that the authors did not adjust for
wound severity and patient comorbidities in comparing groups
(no off-loading vs off-loading, TCC vs other forms of off-loading,
and TCC-EZ vs other forms of off-loading). Second, the number
of wounds that received TCC was relatively small. Last, the authors
did not adjust for any of the results using multivariate analysis.
In conclusion, these data highlight the gap in practice when
it comes to adequate off-loading of DFUs. New, easier-to-apply
TCC kits, such as the TCC-EZ, may increase the frequency of ade-
quate off-loading, but much remains to be done to improve TCC
utilization.&REFERENCES
1. Snyder RJ, Kirsner RS, Warriner RA 3rd, Lavery LA, Hanft JR, Sheehan P. Consensus recom-
mendations on advancing the standard of care for treating neuropathic foot ulcers in patients
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