diabetic foot ulcer off-loading: the gap between evidence ... · diabetic foot ulcers (dfus) are a...

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.

http://WWW.WOUNDCAREJOURNAL.COM

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




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





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


Figure 6.

A PATIENT FOLLOWING THE COMPLETE APPLICATION

OF TCC-EZ


Figure 4.

THE TCC-EZ CAST SOCK IS ROLLED ON TO THE

PATIENT’S AFFECTED FOOT






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.





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.





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

with diabetes. Ostomy Wound Manage 2010;56(Suppl 4):S1-24.

2. Frykberg RG, Rogers LC. Emerging evidence on advanced wound care for diabetic foot

ulcerations. Proceedings from the Superbones West Conference; October 21-24, 2010;

Las Vegas, Nevada. Supplement to Podiatry Today, 2010.

3. Boulton AJ. Pressure and the diabetic foot: clinical science and offloading techniques.

Am J Surg 2004;187(5A):17S-24S.

4. Armstrong DG, Nguyen HC, Lavery LA, van Schie CH, Boulton AJ, Harkless LB. Off-loading the

diabetic foot wound: a randomized clinical trial. Diabetes Care 2001;24:1019-22.

5. Bus SA, Valk GD, van Duersen RW, et al. The effectiveness of footwear and offloading

interventions to prevent and heal foot ulcers and reduce plantar pressure in diabetes: a

systematic review. Diabetes Metab Res Rev 2008;24(Suppl 1):S162-80.

6. Gutekunst DJ, Hastings MK, Bohnert KL, Strube MJ, Sinacore DR. Removable cast walker

boots yield greater forefoot off-loading than total contact casts. Clin Biomech 2011;26:649-54.

7. Lewis J, Lipp A. Pressure-relieving interventions for treating diabetic foot ulcers. Cochrane

Database Syst Rev 2013;1:CD002302.

8. Bus SA. Priorities in offloading the diabetic foot. Diabetes Metab Res Rev 2012;28(Suppl 1):54-9.

9. Prompers L, Huijberts M, Apelqvist J, et al. Delivery of care to diabetic patients with foot

ulcers in daily practice: results of the Eurodiale Study, a prospective cohort study. Diabet Med

2008;25:700-7.

10. Fife CE, Carter MJ, Walker D. Why is it so hard to do the right thing in wound care? Wound

Repair Regen 2010;18:154-8.

11. Horn SD, Fife CE, Smout RJ, Barrett RS, Thomson B. Development of a wound healing

index for patients with chronic wounds. Wound Repair Regen 2013;21:823-32.

12. Stark P. Congressional intent for the HITECH Act. Am J Manag Care 2010;16(12 Suppl HIT):

SP24-8.

13. Fife CE, Carter MJ, Walker D, Thomson B. A retrospective data analysis of antimicrobial

dressing usage in 3,084 patients. Ostomy Wound Manage 2010;56(3):28-42.

14. Wu SC, Jensen JL, Weber AK, Robinson DE, Armstrong DG. Use of pressure offloading devices

in diabetic foot ulcers: do we practice what we preach? Diabetes Care 2008;31:2118-9.

15. Armstrong DG, Lavery LA, Nixon BP, Boulton AJ. It’s not what you put on, but what you

take off: techniques for debriding and off-loading the diabetic foot wound. Clin Infect Dis

2004;39(Suppl 2):S92-9.

16. Armstrong DG, Lavery LA, Wu S, Boulton AJ. Evaluation of removable and irremovable

cast walkers in the healing of diabetic foot wounds. A randomized controlled trial. Diabetes

Care 2005;28:551-4.

17. Armstrong DG, Lavey LA, Kimbriel HR, Nixon B, Boulton AJ. Activity patterns of patients

with diabetic foot ulceration: patients with active ulceration may not adhere to a standard

pressure off-loading regimen. Diabetes Care 2003;26:2595-7.

18. Armstrong DG, Short B, Espensen EH, Abu-Rumman PL, Nixon BP, Boulton AJ. Technique for

fabrication of an ‘‘instant total-contact cast’’ for treatment of neuropathic diabetic foot ulcers.

J Am Podiatr Med Assoc 2002;92:405-8.

19. Katz IA, Harlan B, Miranda-Palma B, et al. A randomized trial of two irremovable off-loading

devices in the management of plantar neuropathic diabetic foot ulcers. Diabetes Care 2005;28:

555-9.

20. Piagessi A, Macchiarini S, Rizzo L, et al. An off-the-shelf instant contact casting device

for the management of diabetic foot ulcers: a randomized prospective trial versus traditional

fiberglass cast. Diabetes Care 2007:30:586-90.

21. Reiber GE, Smith DG, Wallace C, et al. Effect of therapeutic footwear on foot reulceration in

patients with diabetes. A randomized controlled trial. JAMA 2002;287:2252-8.

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Advances in Skin & Wound Care issoliciting manuscripts on a varietyof topics, including original investigations,clinical concepts, and literature reviews.Consult the journal’s Web site,www.woundcarejournal.com, for the Author Guidelines.





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