C o n s e r v a t i v e O ff l o a d i n g

Peter A. Crisologo, DPMa, Lawrence A. Lavery, b

DPM, MPH ,
Javier La Fontaine, DPM, MSb,*

KEYWORDS
 Diabetes  Offloading  Ulcer  Deformity

KEY POINTS
 Diabetic ulcers develop in areas of pressure.
 Neuropathy is essential for development of this ulcer. Deformities need to be recognized
and accommodated with offloading devices.
 Global factors, including blindness, limited joint mobility, and obesity often are obstacles
for proper offloading.
 Total contact cast is the gold standard for offloading a neuropathic ulcer.

INTRODUCTION

The etiology of ulcerations in diabetes mellitus is associated with the presence of pe-
ripheral sensory neuropathy and repetitive trauma due to normal walking activities to
areas on the foot that are subject to moderate or high pressures and shear.1 Pressure
sites on the sole of the foot are often associated with limited joint mobility of the foot or
ankle or structure deformities such as hammertoes and hallux valgus deformity. The
combination of loss of protective sensation, deformity, and repetitive trauma is the
perfect storm for ulcer development. Once an ulcer is developed, the most important
part of the healing process is offloading the ulcer site. Unfortunately, other comorbid
factors such as blindness, loss of proprioception, prior amputations, and obesity
make non–weight-bearing status impossible. The goal of this article is to provide
the reader with the best evidence supported options for offloading of the diabetic
foot ulceration, that could be applied to their patient population.

EVALUATING FOOT DEFORMITY IN PATIENTS WITH DIABETES

In patients with neuropathy, ulcerations typically develop as a result of repetitive pres-

sure and shear on the sole of the foot or from shoe pressure on the top or sides of the

Disclosure Statement: The authors have nothing to disclose.

a
Department of Plastic Surgery, UT Southwestern Medical Center, 5323 Harry Hines Boulevard,
Dallas, TX 75390, USA; b Department of Plastic Surgery and Orthopaedic Surgery, UT South-
western Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA
* Corresponding author.
E-mail address: javier.lafontaine@utsouthwestern.edu

Clin Podiatr Med Surg 36 (2019) 371–379

https://doi.org/10.1016/j.cpm.2019.02.003 podiatric.theclinics.com
0891-8422/19/ª 2019 Elsevier Inc. All rights reserved.
372 Crisologo et al

foot; however, no specific level of pressure has been determined to be abnormal or

pathologic.2 Diabetes alters biomechanics in patients with preexisting structural and
functional foot deformities. Motor neuropathy is thought to contribute to atrophy
and weakness of the intrinsic muscles of the foot. This leads to what has been called
the “intrinsic minus foot,” which describes wasting of the small (intrinsic) muscles that
originate in the foot (see Fig. 4).
Metatarsal ulcers can develop when digital deformities severely contract. The lesser
digits contract and dislocate dorsally, resulting in a claw toe deformity and a strong
plantar flexor force at the metatarsophalangeal joints. As the toes contract and the
metatarsophalangeal joints dislocate, retrograde forces push the metatarsal heads
plantarly.3 Therefore, 3 areas are subject to excessive pressure: the distal tip of the
toes, dorsal aspect of the lesser digits, and the metatarsal heads, which in the pres-
ence of loss of protective sensation, can lead to ulceration.4 Limited mobility of the
ankle and metatarsophalangeal joints has been associated with soft tissue glycosyla-
tion involving the gastro-soleus-Achilles complex and periarticular tissues.5 Limited
motion of the ankle, subtalar, and metatarsophalangeal joints have been associated
with high pressures in the forefoot. Often patients with an intrinsic minus foot will
appear to have a high arch; however, this is not a congenital deformity but rather is
due to atrophy of the abductor hallucis muscle belly on the medial side of the foot.
A profound example of musculoskeletal abnormality of the diabetic foot is represented
by Charcot neuroarthropathy, which is characterized by fracture, subluxation, and/or
dislocation of joints in the foot or ankle. These structural deformities typically cause
plantar bony deformities resulting in areas of high pressure leading to ulceration.
Reduction of pressure and shear forces on the foot may be the single most impor-
tant yet most often neglected aspect of neuropathic ulcer treatment. Offloading ther-
apy is a key part of the treatment plan for diabetic foot ulcers. The goal is to reduce the
pressure at the ulcer site and keep the patient ambulatory.6,7 Several methods are
available to protect the foot from abnormal pressure. Offloading strategies must be
tailored to the age, strength, activity, and home environment of the patient. In general,
however, more restrictive offloading approaches will result in less activity and better
wound healing. Education is critical to improve compliance with offloading. The pa-
tient must understand that the wound is a result of repetitive pressure and that every
unprotected step is literally tearing the wound apart.

Offloading Shoes and Sandals

A number of offloading shoes and sandals or wedged offloading shoes are available to
reduce pressure on the forefoot. These shoes are useful for patients who are not able
to tolerate a total contact cast (TCC), other more appropriate methods of offloading, or
for those who need a transitional device after removal of a TCC while they are awaiting
custom-made therapeutic shoes and insoles.
Surgical shoes with a rocker sole design are preferable to the flat design (Fig. 1) for
postoperative use. Some models of sandal use an insole with hex-shaped portions
that can be removed to offload the ulceration, described previously, and can be
used as a transitional device after closing the wound. The wedged shoe (Fig. 2)
was originally designed to protect the forefoot after elective surgery. This shoe has
a built-in 10-degree dorsiflexory angle, effectively removing pressure from the fore-
foot area and redistributing it to the hindfoot. However, these types of shoes are
not tolerated well by patients because they are difficult to ambulate with. They typi-
cally cause pain of the contralateral extremity, and are often not safe for use in pa-
tients with gait and postural instability. Also, many people with diabetes have equinus
and cannot tolerate the negative heel position created by the shoe. This dorsiflexory
 Conservative Offloading 373

Fig. 1. Healing sandal.

angle causes suspension of the heel during ambulation and subsequently increases
pressure on the forefoot and stresses the midfoot, a common site for collapse in the
diabetic Charcot foot. In a randomized clinical trial that compared TCCs with healing
sandals and removable cast boots, patients in the healing sandal group were less
compliant and used the device during walking significantly less than did subjects
in the TCC group.8

Ankle-Foot Custom-Made Orthoses

Custom-made ankle-foot orthoses are commonly used for moderate to severe lower-
extremity. The Charcot Restraint Orthotic Walker (CROW) (Fig. 3), for example, was
initially used to treat patients with neuropathic fractures, and who acquire rocker-
bottom deformity. It provides protection to the neuropathic foot and aids in controlling
lower-extremity edema. It also allows removal for dressing changes, but is also very
rigid, preventing excessive motion. The rigid polypropylene shell with a rocker-
bottom sole allows accommodation for severe deformities. The CROW can be
adjusted and repaired when deformities change.
The primary drawback to custom-made devices is that they are very expensive and
a good technician is needed. Because a number of cheaper, off-the-shelf products are
now available to treat neuropathic wounds, custom ankle-foot orthoses are used less
often.

Removable Cast Walkers

The effectiveness of removable cast walkers (Fig. 4) to reduce pressure at ulcer sites
has been shown in several studies to be comparable to that of TCCs.9,10 Many prac-
titioners consider removable cast walkers to be their preferred offloading device
because they are less time-consuming and easier to apply than TCCs, and patients

Fig. 2. Wedge shoe.

374 Crisologo et al

Fig. 3. CROW.

more readily accept them. Wounds can be inspected regularly and treated with
advanced wound care products, such as growth factors, electrical stimulation,
and other biologically active dressings. Also, the wound and limb can be inspected
frequently.
There are additional advantages to using a removable cast walker compared with
the TCC. Removable cast walkers are relatively inexpensive and the protective insole
can be easily replaced if it shows signs of wear. No special training is required for cor-
rect and safe application and they can be easily removed for wound assessment and
treatment.11 It is also possible to modify removable walkers into nonremovable de-
vices by securing the walker with cast material or a nonremovable cable tie; this is
known as an instant TCC. If patients cannot remove the walker, the element of forced
compliance that makes the TCC attractive is maintained and the outcomes for healing
improve to the levels seen with the TCC.12,13
No single offloading device is appropriate for every patient. McGuire14 has
suggested a transitional approach to healing and maturing the diabetic foot ulcer
that uses the instant TCC for initial pressure management and transitioning to
removable devices and shoe-based platforms before the patient is ready for defin-
itive footwear.
In a randomized controlled trial, Armstrong and colleagues11 compared the effec-
tiveness of TCCs, removable cast walkers, and half-shoes in healing neuropathic
foot ulcerations in individuals with diabetes. The percentage of healing at 12 weeks
was 89.5% for the TCC, 65.0% for the cast walker, and 58.3% for the half-shoe.
When the cast walker is made nonremovable (“instant” total contact cast), the differ-
ence between the TCC and cast walker effectively disappears.15
 Conservative Offloading 375

Fig. 4. Removable cast walker.

Total Contact Cast

Use of a TCC (Figs. 5 and 6) is considered the gold standard for offloading the foot.
TCCs reduce pressure at the ulcer site while still allowing the patient to be ambula-
tory.9 Although it is a useful tool, a skilled clinician or technician is required to apply
the cast to ensure a proper fit. A poorly fitting cast can cause iatrogenic wounds. A
TCC is a modified traditional cast that uses minimal cast padding. This minimal
padding is what allows the cast to totally contact the limb, thus limiting potential mo-
tion and allowing for equal weight distribution. The cast is molded to the shape and
contour of the limb so movement is not possible within the cast. TCCs are generally
changed every week to 2 weeks but may need to be replaced more frequently in pa-
tients with other comorbidities.
A TCC is one of the most effective ways of treating plantar neuropathic foot ulcers.
Numerous studies10,16–18 have shown that TCCs can heal ulcers in 6 to 8 weeks. The
TCC has been shown to decrease pressure to the toes, forefoot, and heel when
properly applied.19 Multiple studies have shown that a TCC heals a higher portion
of wounds than topical growth factors, bioengineered tissue, or other alternative
methods.20,21
Patients who use a TCC are controlled for compliance of use. Although they have
the cast applied, the ulceration is protected and the pressure distributed away from
376 Crisologo et al

Fig. 5. TCC.

Fig. 6. TCC with cast shoe.

 Conservative Offloading 377

the ulceration and more toward otherwise non–weight-bearing areas, such as the mid-
foot.19 The ulcer is protected with every step the patient takes and compliance is
improved, as it is a nonremovable method of offloading. The TCC also reduces the pa-
tient’s activity level given its weight and size. This in turn decreases stride length,
cadence, and pressure at the ulcer site.9,10 The main disadvantages for patients are
from a comfort standpoint; TCCs are heavy, hot, and itchy, and it is not removable,
which makes some patients feel trapped.
Recent evidence
A meta-analysis by Elraiyah and colleagues22 investigated the best available evi-
dence in offloading methods for the diabetic foot ulcer. They identified 19 interven-
tional studies, of which 13 were randomized controlled trials, including data from
1605 patients with diabetic foot ulcers using an offloading method. Their group still
demonstrated that TCCs present better evidence to support superior offloading for
foot ulcers when compared with a removable cast walker, and other offloading de-
vices. Also, the study by Bus and colleagues23 demonstrated that removable de-
vices are not as effective as nonremovable devices, but they could be considered
for those who cannot tolerate a nonremovable device. In this single-blinded multi-
center study, their results show anywhere between 58% and 70% healing of foot
ulcers at 12 weeks with 3 different removable offloading devices (bivalved TCC,
custom-made ankle high cast shoe, and a prefabricated ankle high forefoot offload-
ing shoe) in their intention-to-treat analysis. Significance was not noted among the 3
devices evaluated.

SUMMARY

Offloading and local wound care continue to be the most essential part of foot ulcer
healing. Several methods are available to protect the foot from abnormal pressures.
The evidence supports that irremovable devices have a slight edge over removable
devices likely due to forced compliance. In general, more restrictive offloading ap-
proaches will result in less activity and better wound healing. Offloading needs to
be individualized. For many patients, a TCC is not a reasonable option, as their overall
health status or personal reasons do not allow for safe or effective use. Therefore, opti-
mizing individual offloading options for each patient is essential.
Reduction of pressure and shear forces on the foot is the single most important, yet
most often neglected, aspect of neuropathic ulcer treatment. Offloading therapy is a
key part of the treatment plan for diabetic foot ulcers. The goal is to reduce the pres-
sure at the ulcer site while still allowing the patient to remain ambulatory for daily and
necessary activities.6,7 The patient must also be educated that the wound is a result of
repetitive pressure and that every step is causing further damage and worsening of the
wound. With proper offloading, this damage can be mitigated. Therefore, education is
critical to improve compliance with offloading.

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