Total Contact Cast Use in Patients With Peripheral Arterial Disease: A Case Series and Systematic Review

Abstract

Introduction:
As the majority of diabetic foot ulcerations (DFUs) occur on the plantar foot, excessive pressure is a major contributing factor to delayed healing. The gold standard for offloading is the total contact cast (TCC); yet, TCC use is contraindicated in patients with ischemia. Lower extremity ischemia typically presents in the more severe end stages of peripheral arterial disease (PAD). As PAD exists on a severity spectrum from mild to severe, designation of a clear cutoff where TCC use is an absolute contraindication would assist those who treat DFUs on a daily basis.

Objective:
The aim of this study is to determine if a potential cutoff value for PAD where TCC use would be an absolute contraindication could be ascertained from a retrospective case series and a systematic literature review of patients with PAD in which treatment included TCC use.

Materials and methods:
A retrospective cases series and systematic review of patients with mild to moderate PAD treated with a TCC was performed. All reports of TCC use in patients with PAD and a neuropathic ulceration that included results of noninvasive vascular studies were included.

Results:
Results suggested that TCC use is a viable treatment modality for pressure-related DFUs in patients with an ankle pressure ≥ 80 mm Hg, a toe pressure ≥ 74 mm Hg, an ankle-brachial index ≥ 0.55, or a toe-brachial index ≥ 0.55.

Conclusions:
Vascular evaluation, individual risk/benefit analysis, close follow-up, and patient education are essential components of TCC use in these patients. Repeat vascular evaluation is recommended if the wound fails to progress towards resolution with TCC use.

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CASE SERIES
The prevalence of peripheral arterial
disease (PAD) in the general population
ranges from 10% to 40%.1,2 In the clinical
practice guidelines for management of the
diabetic foot put forth by the Society for
Vascular Surgery, the American Podiatric
Medical Association, and the Society for
Vascular Medicine, at least 65% of diabetic
foot ulcerations (DFUs) are reported to
be complicated by PAD.1 The Eurodiale
study, a 1-year retrospective review of
all patients presenting with a DFU at 14
diabetic foot centers in Europe, found
that 61% of patients had PAD.2 Of these
patients, 49% were defined as having
moderate PAD, with an ankle-brachial
index (ABI) < 0.9 or absent palpable pedal
pulses, and 12% were defined as having
severe PAD with an ABI < 0.5. In addition,
32% of patients had falsely elevated ABIs,
making the diagnosis of PAD severity dif-
ficult. The prevalence of PAD was found
to increase with age > 70 years and the
presence of disabling comorbidities. Heal-
ing rates were worst when DFUs were
complicated by both PAD and infection.
However, these types of ulcerations oc-
curred more often on the dorsal aspect of
the foot where pressure is less likely to be
a contributing factor to delayed healing.2
Offloading has been reported to be
the single most important factor in the
resolution of plantar neuropathic ulcer-
ations.3,4 Postoperative shoe and remov-
able cast walker use are the most common
offloading modalities employed.5-8
However, these offloading modalities rely
heavily on patient compliance with use for
success. Studies have shown that patients
often only use these devices between
2% to 28% of waking/walking hours,
making the associated prolonged healing
times and greater incidence of infection
and amputation not surprising.9-11 Dr.
Paul Brand brought the concept of the
total contact cast (TCC) to the United
States in the 1960s as a treatment for
leprosy-related neuropathic ulcerations.12
The TCC later became touted as the gold
standard for offloading plantar DFUs as it
forces patient compliance; provides the
greatest reduction in peak plantar pres-
sures, particularly to the forefoot; and has
reported resolution rates ≥ 73%.3,5,6,8,10,13-21
Anthony Tickner, DPM, DABPM, FACCWS, FAPWCA, FAPWH1; Cheri Klinghard, RN, BSN, CWON, DWC2; Jonathan F. Arnold, MD,
ABPM-UHM, CWS-P3; and Valerie Marmolejo, DPM4
Total Contact Cast Use in Patients With
Peripheral Arterial Disease: A Case Series
and Systematic Review

Introduction. As the majority of diabetic foot ulcerations (DFUs) occur on the plantar foot, excessive pressure is a major contributing
factor to delayed healing. The gold standard for offloading is the total contact cast (TCC); yet, TCC use is contraindicated in patients with
ischemia. Lower extremity ischemia typically presents in the more severe end stages of peripheral arterial disease (PAD). As PAD exists on
a severity spectrum from mild to severe, designation of a clear cutoff where TCC use is an absolute contraindication would assist those
who treat DFUs on a daily basis. Objective. The aim of this study is to determine if a potential cutoff value for PAD where TCC use would
be an absolute contraindication could be ascertained from a retrospective case series and a systematic literature review of patients with
PAD in which treatment included TCC use. Materials and Methods. A retrospective cases series and systematic review of patients with
mild to moderate PAD treated with a TCC was performed. All reports of TCC use in patients with PAD and a neuropathic ulceration that
included results of noninvasive vascular studies were included. Results. Results suggested that TCC use is a viable treatment modality for
pressure-related DFUs in patients with an ankle pressure ≥ 80 mm Hg, a toe pressure ≥ 74 mm Hg, an ankle-brachial index ≥ 0.55, or a
toe-brachial index ≥ 0.55. Conclusions. Vascular evaluation, individual risk/benefit analysis, close follow-up, and patient education are
essential components of TCC use in these patients. Repeat vascular evaluation is recommended if the wound fails to progress towards
resolution with TCC use.
 
Wagner Grade, offloading, diabetic foot ulcer

Wounds 2018;30(2):49–56.
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February 2018 | vol. 30, no. 2 
TCC Use in Patients With PAD
However, its use remains limited due to
a variety of clinician, organization, and
patient-related barriers. One of these
barriers is the contraindication of use
when ischemia or severe PAD is present,
although a clear definition or cutoff value
has not been defined.5,8,21-29
As PAD exists on a spectrum of severity,
with ischemia typically noted in the end
stages, and the prevalence of neuroisch-
emic neuropathic ulcerations on the rise,
a clear cutoff value for PAD that would
make TCC use an absolute contraindica-
tion would assist clinical decision-making
for these patients. The aim of this study is
to determine if a potential cutoff value for
PAD where TCC use would be an absolute
contraindication could be ascertained
from a retrospective case series and a
systematic literature review of patients
with PAD in which treatment included
TCC use.
MATERIALS AND METHODS
A retrospective case series and a
systematic review of patients with PAD
and a plantar neuropathic ulceration that
was treated with a TCC was performed.
The retrospective cases came from 2
clinics that specialized in the treatment
of chronic wounds. All selected cases
involved the use of a TCC in patients with
a diagnosis of PAD.
Literature search was restricted to
English language, peer-reviewed journals,
and utilized an inclusive text word query
of ischemia OR peripheral arterial disease
OR arterial insufficiency AND total contact
cast AND neuropathic AND ulceration (with
all-capital words representing the Boolean
operators used). Literature search was
performed from date of inception through
December 2015. Each reference was then
manually searched for additional perti-
nent references. All reports of TCC use
in patients with PAD and a neuropathic
ulceration that included results of non-
invasive vascular studies were included.
After identification and review of the
included reports, data extracted from the
studies included total number of patients,
total number of feet, gender, laterality,
patient age, duration of diabetes, duration
of ulceration, vascular examination and
Table 1. Retrospective review of patients with peripheral arterial disease and plantar neuropathic
ulceration treated with a total contact cast; (A) healed and (B) amputation
A. HEALED
Gender/
Age
HgbA1c
%
Foot/
Ulcer
Location
Ulcer
Duration
(mos)
Area
(cm2)
Volume
(cm3)
SBP
L/R
AP
L/R
ABI
L/R
TP
L/R
TBI
L/R
Time to
Healing
(mos)
Total
No. of
TCC
Reason for TCC
Discontinuation
M/47 7.4 % R heel 0.0 23.1 4.6 R: 144 R: NP RaR: 48.90 R: 0.34 3.7 1Fall risk
M/52 Not
obtained
R
midfoot 0.4 10.6 1.1 R: 140 R: 90 R:
0.64 R: 41.60 R: 0.30 1.4 6
F/54 8.8% L hallux 0.3 0.1 0.0 L: 145 L:
100 L: 0.69 L:
130.00 L: 0.90 1.4 11
F/54 Not
recorded L heel 7.1 15.0 3.0 L: 0.50 2.4 8
M/63 8.7% L hallux 11.4 0.5 0.2 L: 131 L:
100 L: 0.76 L:
132.40 L: 1.01 0.9 4
M/65 7.5% R heel 2.2 0.8 0.2 R: 142 R: 88 R: 0.62 R: 53.20 R: 0.37 2.6 2
M/68 10.4% L heel 1.9 5.3 1.1 L: 148 L: 90 L: 0.61 L: 63.80 L: 0.43 14.5 1
Could not
tolerate; referred
to vascular;
intervention
performed
F/69 6.8% L heel 0.7 23.8 4.8 L: 145 L: NP L: NC L: 99.10 L: 0.68 6.0 16
M/73 8.6% L heel 1.9 2.1 0.6 L: 138 L: NP L: NC L: 58.10 L: 0.42 3.8 1Fall risk
F/84 NonDM L PMTH 0.5 1.8 0.2 L: NP
R: 144 L: 80 L:
0.56bL: 57.30 L:
0.40b2.5 2
a Could not be calculated
b Contralateral upper extremity systolic brachial artery pressure used for calculation
HbA1c: hemoglobin; SBP: systolic brachial artery pressure; L: left; R: right; AP: systolic ankle pressure ; ABI: ankle-brachial index; TP: systolic
toe pressure; TBI: toe-brachial index; TCC: total contact cast; NP: not performed; NC: noncompressible; NonDM: nondiabetic; PMTH: plantar
metarsal head; TOB: tobacco use ; PAD: peripheral arterial disease
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Tickner et al
noninvasive vascular study results, time
to healing, unresolved wounds, amputa-
tion, and complications. The data collect-
ed were reviewed and analyzed in order to
determine if a cutoff value for PAD where
TCC use would be an absolute contraindi-
cation could be determined.
RESULTS
Retrospective review
A total of 14 patients (10 males, 4 females)
were identified (Table 1). The right foot
was affected in 6 patients and the left in
8. Mean patient age was 61.5 ± 10.3 years
(range, 47–84 years). Only 1 (7.1%) patient
did not have diabetes mellitus. Hemo-
globin A1c was recorded in 10 of the 13
remaining patients with a mean of 8.4% ±
1.5% (range, 6.2%–11.0%). The majority of
ulcerations were located on the heel (7;
50%) followed by the metatarsal head (3;
21.4%), the hallux (3; 21.4%), and the mid-
foot (1; 7.1%). Mean ulcer duration was 1.9
± 6.5 months (range, 0–24 months). Mean
ulcer area was 2.1 ± 8.1 cm2 (range, 0–24
cm2). Mean ulcer volume was 0.5 ± 1.6 cm³
(range, 0–5 cm3) (Figure).
Systolic brachial artery pressure was
obtained in the ipsilateral upper extremity
for 13 patients and the contralateral upper
extremity for 1 patient. Mean systolic bra-
chial artery pressure on the left was 141.5
± 11.7 mm Hg (range, 117–148 mm Hg)
and 142.0 ± 25.9 mm Hg (range, 99–183
mm Hg) on the right. Mean systolic ankle
pressure for the left and right lower
extremities were similar at 90.0 ± 11.7 mm
Hg (range, 70–140 mm Hg) and 90.0 ±
26.7 mm Hg (range, 70–140 mm Hg), re-
spectively. Mean ABI for the left and right
lower extremities also were similar at 0.62
± 0.9 mm Hg (range, 0.50–0.76 mm Hg)
and 0.62 ± 0.36 mm Hg (range, 0.59–1.41
mm Hg), respectively. Mean systolic toe
pressure and toe-brachial index (TBI)
Table 1. Retrospective review of patients with peripheral arterial disease and plantar neuropathic
ulceration treated with a total contact cast; (A) healed and (B) amputation
B. AMPUTATION
Gender/
Age
HgbA1c
%
Foot/
Ulcer
Location
Ulcer
Duration
(mos)
Area
(cm2)
Volume
(cm3)
SBP
L/R
AP
L/R
ABI
L/R
TP
L/R
TBI
L/R
Time to
Healing
(mos)
Total
No.
of
TCC
Reason
for TCC
Discon-
tinuation
Reason for
Amputation
M/51 11.0% L hallux 0.0 1.1 0.1 L: 117 L: 74 L:
0.63
L:
94.4
L:
0.81 Amp 2Work
related
Active TOB
use; 2 TCC
applications
M/59 8.1% R PMTH 5.9 2.8 0.6 R:
NP
R:
NP RaR: NP RaAmp 2Patient
refusal
Active TOB
use; 2 TCC
applications
M/60 6.2% R PMTH 2.7 0.8 0.2 R:
118
R:
70
R:
0.59 R: 54 R:
0.46 Amp 3Work
related
Active TOB
use; severe
PAD
M/78 R heel 0.3 5.0 0.5 R:
183
R:
110
R:
0.60 R: NP R:
NC Amp 1Unstable
gait
Former TOB
use; 1 TCC
application;
postoperative
complication
M/51 11.0% L hallux 0.0 1.1 0.1 L: 117 L: 74 L:
0.63
L:
94.4
L:
0.81 Amp 2Work
related
Active TOB
use; 2 TCC
applications
M/59 8.1% R PMTH 5.9 2.8 0.6 R:
NP
R:
NP RaR: NP RaAmp 2Patient
refusal
Active TOB
use; 2 TCC
applications
M/60 6.2% R PMTH 2.7 0.8 0.2 R:
118
R:
70
R:
0.59 R: 54 R:
0.46 Amp 3Work
related
Active TOB
use; severe
PAD
a Could not be calculated
b Contralateral upper extremity systolic brachial artery pressure used for calculation
HbA1c: hemoglobin; SBP: systolic brachial artery pressure; L: left; R: right; AP: systolic ankle pressure ; ABI: ankle-brachial index; TP: systolic
toe pressure; TBI: toe-brachial index; TCC: total contact cast; NP: not performed; NC: noncompressible; NonDM: nondiabetic; PMTH: plantar
metarsal head; AMP: amputation; TOB: tobacco use ; PAD: peripheral arterial disease
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TCC Use in Patients With PAD
did vary from left to right: 94.4 ± 32.3 mm
Hg (range, 57.3–132.4 mm Hg) and 53.2 ±
21.0 mm Hg (range, 41.6–95.0 mm Hg)
compared with 0.68 ± 0.25 mm Hg (range,
0.40–1.01 mm Hg) and 0.37 ± 0.27 mm Hg
(range, 0.30–0.96 mm Hg), respectively.
Ten (71.4%) patients achieved wound
resolution. Mean time to healing was 2.5
± 4.2 months (range, 0–14.5 months). An
average of 5.2 ± 5.1 (range, 1–16) TCC ap-
plications were performed. Only 1 (10%)
patient could not tolerate the TCC after 1
application. This patient was referred for
vascular evaluation and underwent revas-
cularization, which resulted in wound res-
olution 1.3 months later. Discontinuation
of TCC occurred in 2 other patients as
they were deemed to be a fall risk with the
cast on. The remaining 7 (70%) patients
continued with TCC use until deemed no
longer necessary by the treating provider.
Time to healing differed between the 7
patients who continued TCC use com-
pared with the 3 who discontinued TCC
use after 1 application, 3.7 ± 4.2 months
versus 7.3 ± 6.2 months, respectively.
Four (28.6%) patients underwent
amputation. None of the amputations
occurred from complications sustained
from TCC application technique or use.
A similar factor for each of these patients
was discontinuation of TCC use: work
related (2 patients), unstable gait (1
patient), and refusal with continuation of
use (1 patient). Average TCC applications
were 2.0 ± 0.8 (range, 1–3). The 2 pa-
tients who discontinued TCC use for
work-related reasons were both active
tobacco users; 1 had a plantar metatarsal
head ulceration and history of severe PAD
with prior revascularization performed
and no options for further intervention.
The other patient had a hallux amputa-
tion. Upon discontinuation of TCC use
in both of these patients, their wounds
subsequently worsened and necessitated
partial foot amputation. The remaining 2
patients (unstable gait and refusal to use)
both had a below-knee amputation. One
had a recurrent plantar metatarsal head
ulceration that had previously healed in
1 month with 6 TCC applications; this
patient refused continued TCC use and
underwent amputation 5 months later.
The second patient had ulceration of
the heel; a rotational flap was attempted
Figure. A 54-year-old Caucasian woman with type 2 diabetes mellitus and peripheral arterial disease
with an ankle-brachial index of 0.5 presented with an infected left heel ulceration. (A) Measurements
after operative debridement were 10.7 cm x 6.0 cm x 2.5 cm; (B) total contact cast (TCC) and
dehydrated amniotic membrane allograft (DAMA) application were initiated at 7.5 months after treat-
ment with hypertonic sodium chloride dressings, negative pressure wound therapy, and hyberbaric
oxygen therapy. Measurements at this time were 6.0 cm x 2.5 cm x 0.2 cm; (C) 2 weeks after TCC use,
measurements were 5.3 cm x 1.8 cm x 0.2 cm; and (D) wound resolution achieved at 10.5 weeks after 8
TCC and DAMA applications. This is an example case from this retrospective cases series.
A
C
B
D
KEYPOINTS
• A total of 14 patients (10
males, 4 females) were
identified with the right foot
affected in 6 patients and the
left in 8.
• Ten (71.4%) patients achieved
wound resolution with a
mean time to healing at 2.5
± 4.2 months (range, 0–14.5
months).
• An average of 5.2 ± 5.1 (range,
1–16) total contact cast (TCC)
applications were performed;
only 1 (10%) patient could
not tolerate the TCC after 1
application.
• Four (28.6%) patients under-
went amputation, but were
not a result of the TCC or
application of TCC.
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Tickner et al
for closure and failed in the immediate
postoperative period due to the patient
stepping on the foot.
Systematic review
The literary search for potentially eligible
information yielded a total of 8 refer-
ences of which only 1 (12.5%) contained
patient-specific, noninvasive vascular
study results.30 Level of evidence for this
study was Level 4, therapeutic, and the
methodological quality was fair. Results
of 6 patients were reported. Mean patient
age was 65.5 ± 6.5 years (range, 53–70
years). Mean diabetes duration was 17.0 ±
5.7 years (range, 10–25 years). Mean ulcer
duration was 12.5 ± 6.4 months (range,
1.4–18 months). Mean ulcer area and
volume were 1.9 ± 3.9 cm2 (range, 0.6–10.9
cm2) and 0.6 ± 1.5 cm3 (range, 0.1–3.0
cm3), respectively. The mean ABI was 0.4
± 0.1 (range, 0.4–0.7). Four (66.7%) pa-
tients healed at a mean of 1.3 ± 1.1 months
(range, 0.8–3.3 months). The remaining
2 patients had unresolved ulcerations,
although 1 of these patients with a heel
ulceration had TCC treatment discontin-
ued after development of anterior shin
contact dermatitis, and the other refused
additional TCC applications despite
reduction in size of their plantar fifth
metatarsal head ulceration (Table 230).
DISCUSSION
Total contact cast use is currently con-
traindicated in the presence of PAD and/
or ischemia. However, a clear cutoff value
has never been defined. It is the respon-
sibility of the provider to weigh the risks
and benefits of TCC use for each patient
with PAD to determine if a trial of use
is indicated as treatment for a pressure-
related neuropathic ulceration. This
retrospective case review and additional
systematic literature review provides
evidence that TCC use in patients with
an ankle pressure ≥ 90 mm Hg, a toe pres-
sure ≥ 74 mm Hg, an ABI ≥ 0.5, or a TBI ≥
0.5 may be a viable option for treatment
of pressure-related DFUs. While only 1
study30 provided specific data on TCC use
in patients with PAD, several studies12,27,31-37
did include patients with PAD and a DFU
who were treated with a TCC. Results
gleaned from these articles combined
with the results herein suggest that TCC
use may be a treatment option in patients
with an ankle pressure ≥ 80 mm Hg, a toe
pressure ≥ 74 mm Hg, an ABI ≥ 0.55, or a
TBI ≥ 0.55 and a pressure-related neuro-
pathic ulceration.12,27,30-37
One retrospective review,35 which did
not include results of noninvasive vascu-
lar studies, reported a 100% resolution
rate (6 patients, 8 ulcerations) in a mean
of 5 weeks. Wound resolution occurred
for the oldest patient in the study (aged
75 years) despite the patient having a
nonpalpable dorsalis pedis artery.35
A retrospective review30 of 30 patients
(33 DFUs) treated with a TCC included
the treatment of 6 patients with PAD
(defined as having an ABI < 1.0). All 6 pa-
tients were male, had insulin-dependent
diabetes mellitus for an average of 16.8 ±
5.7 years (range, 53–70 years), and had an
average ABI of 0.5 ± 0.1 (range, 0.38–0.66)
(Table 230). Average ulceration dura-
tion was 11.9 ± 6.4 months (range, 1.4–18
months). Average ulcer area and volume
was 3.3 ± 3.9 cm2 (range, 0.61–0.9 cm2)
and 1.3 ± 1.5 cm3 (range, 0.1–3.3 cm3),
respectively. Of the 6 patients, 4 (66.7%)
achieved wound resolution at an average
of 1.6 ± 1.1 months (range, 0.8–3.3
months). Of the 2 unresolved wounds, 1
was a heel ulceration where TCC use was
Table 2. Results of patients with peripheral arterial disease treated with
a total contact cast in the study by Sinacore et al30
GENDER/
AGE
DURATION
OF IDDM (y)
ULCER
LOCATION
ULCER
DURATION
(mos)
AREA
(cm2)
VOLUME
(cm3)ABI
TIME TO
HEALING
(mos)
OUTCOME
M/60 14.0 5th MTH 18.0 0.6 0.1 0.4
Refused continued TCC
application despite
reduction in ulcer size
M/70 10.0 Heel 9.0 1.5 0.5 0.4
TCC discontinued due to
development of anterior
shin contact dermatitis
M/65 25.0 2nd–3rd
MTH 18.0 3.4 3.0 0.4 1.2 Healed
M/70 20.0 1st–2nd
MTH 1.4 2.2 0.7 0.7 0.8 Healed
M/66 12.0 CN area 10.0 0.9 0.2 0.5 1.3 Healed
M/53 20.0 5th MTH 15.0 10.9 3.3 0.4 3.3 Healed
IDDM: insulin dependent diabetes mellitus; ABI: ankle-brachial index; M: male; MTH: metatarsal head; TCC: total contact cast; CN: calca-
neonavicular
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TCC Use in Patients With PAD
discontinued after the patient developed
contact dermatitis on the anterior shin
and the other was a plantar fifth metatar-
sal head ulceration that had reduced in
size prior to patient refusal of continued
TCC application.30
Two retrospective reviews included
patients with an ABI ≥ 0.45 and a systolic
ankle pressure ≥ 70 mm Hg.33,34 A 73%
healing rate in just over 1 month was
reported in the study by Helm et al.33 The
other study by Walker et al34 developed a
predictive equation for the healing time of
both forefoot and nonforefoot ulcerations
treated with a TCC via regression anal-
ysis. These predictive equations were
based on patient age and gender and ulcer
duration, grade, and long and short diam-
eters; PAD was not found to be a contrib-
uting factor.34 Laing et al12 performed a
retrospective review on 46 patients (36
diabetics, 10 nondiabetics) with 56 plantar
neuropathic ulcerations. Ulcerations were
present for a mean of 17 months. An 81%
resolution rate at an average of 6 weeks
was reported. Of the 8 unresolved ulcer-
ations, 6 (75%) occurred in patients with
an average ABI of 0.61 (range, 0.44–0.81).
One of these unresolved ulcerations
(plantar fifth metatarsal head) lead to
partial fifth ray resection due to the
patient waiting 1 week to be seen despite
experiencing pain beginning 2 days after
TCC application (ABI = 0.67). Given the
results of their respective studies, all
authors12,30,33-35 found that a trial of TCC
use in patients with a pressure-related
ulceration and PAD, defined as an ABI >
0.44 and < 1.0, was reasonable as wounds
only failed to progress and did not worsen
if patients were seen promptly. Individual
patient risk and benefit assessment and
the importance of patient education were
stressed. Vascular evaluation was recom-
mended if these wounds failed to progress
after initiation of TCC use.12,30,33,34 It must
be stated that all of these studies occurred
in the late 1980s and 1990s. Expeditious
vascular evaluation is currently recom-
mended for any patient where a concern
of PAD exists.
Three studies26,36,37 involved the pro-
spective collection of data on TCC use for
the treatment of DFUs. Mueller et al36 per-
formed a prospective, controlled clinical
trial comparing TCC use with daily dress-
ing changes. No significant difference
existed between the 2 study groups in
regard to age, type of diabetes, duration of
diabetes, ulcer duration, ulcer size, ulcer
grade, severity of peripheral neuropathy,
or presence of PAD (defined as an ABI >
0.5 and < 0.99). Two patients in the TCC
group and 3 in the daily dressing change
group had PAD, including 1 patient in each
group who had an ABI < 0.5. A 90% res-
olution rate at a mean of 1.4 months was
reported for the TCC group compared
with a 32% resolution rate at a mean of
2.2 months for the daily dressing change
group. Failure to achieve wound resolu-
tion was attributed to PAD for only 1 pa-
tient in the TCC group. While the patient
achieved reduction in wound size during
the 3-month study period, the ulceration
remained unresolved. The patient
developed a severe infection requiring
hospitalization within 3 weeks of study
completion and TCC discontinuation.
The patient’s ABI at that time was 0.42
and was subsequently referred for formal
vascular evaluation. No further follow-up
was reported. Nabuurs-Franssen et al28
performed a 5-year retrospective review
of prospectively collected data on TCC
use in all patients within their facility
who presented with a DFU. Of the 98
patients, 44% had PAD defined as no signs
of critical limb ischemia (CLI) and 1 or
more of the following: absent palpable
pedal pulses, presence of intermittent
claudication, an ABI < 0.9, a TBI < 0.6,
and a transcutaneous oxygen pressure
measurement (TCOM) between 30 mm
Hg and 60 mm Hg. An overall healing rate
of 76% at a mean of 33 days was reported.
In patients with a noninfected DFU and
PAD, a 69% healing rate at a mean of 42
days was reported. The presence of PAD
did not hinder healing of any plantar first
metatarsal head ulcerations or contribute
to the development of superficial iatro-
genic ulceration.
Ha Van et al37 performed a prospec-
tive, nonrandomized trial comparing
the use of a windowed TCC to that of an
offloading shoe. Patients with moderate
and severe PAD were included in the
study. Moderate PAD was defined as
presence of at least 1 nonpalpable pedal
pulse with arterial lesion detected by
Doppler ultrasound and maintenance
of at least 1 major artery to the foot, a
TCOM between 20 mm Hg to 30 mm Hg,
a history of successful revascularization
and no ischemic trophic disorders, and
no necrosis or gangrene. Severe PAD was
defined as CLI, a wound with gangrene
or necrosis, a TCOM < 20 mm Hg, failure
to detect a single major artery to the foot
on Doppler ultrasound, or severe arterial
lesions seen on arteriography. No signif-
icant difference in age, gender, type of
diabetes, duration of diabetes, body mass
index, HbA1c, or ulcer duration existed be-
tween the 2 study groups. The TCC group
had an increased healing rate with a
decreased time to healing compared with
the offloading shoe group (81% vs. 70%
KEYPOINTS
• The literary search for potentially eligible information yielded a total of 8
references of which only 1 (12.5%) contained patient-specific, noninvasive
vascular study results.30
• This retrospective case review and additional systematic literature review
provides evidence that total contact cast use in patients with an ankle
pressure ≥ 90 mm Hg, a toe pressure ≥ 74 mm Hg, an ankle-brachial index
≥ 0.5, or a ≥ 0.5 toe-brachial index may be a viable option for treatment of
pressure-related diabetic foot ulcers.
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woundsresearch.com 
Tickner et al
and 2.3 ± 1.2 months vs. 4.5 ± 4.4 months,
respectively) despite the TCC group
having significantly more patients with
ulcerations of longer duration, greater
width and depth, and midfoot Charcot
foot deformity. Patient age and TCC use
were the only 2 variables found to have a
statistically significant positive prognos-
tic factor for healing. The retrospective
review performed herein also noted an
association between TCC discontinuation
and longer healing times and amputation.
LIMITATIONS
Limitations of this study include the
small sample size, the paucity of literature
regarding TCC use in patients with PAD,
and the potential for inconclusive non-
invasive vascular study results secondary
to medial calcinosis and collateralization.
However, given the vast variation in PAD
severity and the increasing prevalence of
neuroischemic DFUs that require offload-
ing to heal, it is imperative to determine
a cutoff value and definition of ischemia
which absolutely precludes TCC use.
A systematic review38 of the ability of
prognostic markers to predict wound
healing and amputation in patients with
DFUs found that a systolic ankle pressure
> 70 mm Hg or the combination of a
systolic ankle pressure > 50 mm Hg with
an ABI > 0.5 was found to have the largest
positive likelihood ratio for prediction of
amputation, independent of the wound
care and offloading modalities employed.
Similar results and recommendations
were found in the present retrospective
case series and systematic review. While
ABI results in patients with diabetes have
been reported to be falsely elevated half
the time, an ABI is still the most common
noninvasive vascular study performed to
determine adequacy of arterial supply.
When the results are unobtainable or
inconclusive, further studies that have
been shown to be less likely to be affected
by medial calcinosis and collateralization
such as a TBI or TCOM have been
employed.39,40 Thus, cutoff values for sys-
tolic ankle and toe pressure and TBI also
were determined for this study. Formal
vascular evaluation should be obtained
for any patient in which the concern for
PAD exists. Providers also must perform
individual patient risk and benefit assess-
ment, have staff trained in proper TCC
application and removal techniques, have
the ability to perform weekly and more
urgent follow up as needed, and perform
repetitive patient education on cast safety
and maintenance to minimize potential
complications in these patients.
CONCLUSIONS
Dr. Brand stated, “Only a small percent-
age of diabetic patients have vascular
compromise to such an extent as to
prevent a plantar foot ulcer from healing
after the pressure of walking has been
relieved.”32 He reported not having seen
any lower extremity ischemia in patients
with diabetes severe enough to prevent
TCC use during 17 years of practice.32
This retrospective case review and
systematic literature review to include
data from other studies on TCC use in
patients with PAD suggest that TCC use
in patients with an ankle pressure ≥ 80
mm Hg, a toe pressure ≥ 74 mm Hg, an
ABI ≥ 0.55, or a TBI ≥ 0.55 may be a viable
treatment option for pressure-related
neuropathic ulcerations. Discontinuation
of TCC was associated with longer
healing times and amputation. Vascular
evaluation should be employed in all
patients with PAD and a pressure-related
neuropathic ulceration. Repeat evaluation
should be obtained if the wound fails to
progress towards resolution with TCC
use.

Affiliations: 1Limb Salvage & Amputation Prevention
Services, Restorix Health Wound Healing Center of
Saint Vincent Hospital, Worchester, MA; 2Program
Director, Restorix Health Wound Healing Center of
Saint Vincent Hospital; 3Medical Director, Great River
Wound and Hyperbaric Medicine Clinic, West
Burlington, IA; and 4Scriptum Medica Medical
Writing, University Place, WA
Correspondence: Valerie Marmolejo, DPM, Medical
Writer, Scriptum Medica Medical Writing, P.O. Box
65965, University Place, WA 98466;
www.scriptummedica.com; vlsdpm@gmail.com
Disclosure: The authors disclose no financial or
other conflicts of interest. The opinions or
assertions contained herein are the private view of
the authors and are not to be construed as official
or reflecting the views of Saint Vincent Hospital.

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