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بخشی از مقاله انگلیسی:
Diabetes is a global epidemic
and is one of the most significant public health challenges of our day.
It is estimated that 642 million people worldwide will have diabetes
by 2040,1 of which about 50% will develop peripheral neuropathy (PN).2
Largely because of PN and loss of protective sensation, lower extremity
complications of diabetes constitute a major public burden in both the
developed and developing world and affect 15-25% of those with PN.2-5
The most common complication, the diabetic foot wound, occurs most
frequently when pressure and shear (cycles of stress) are multiplied by
activity (episodes of initiating movement, walking, and standing).6,7
Management of physical activity and its overall pattern including
postures and weight-bearing activities in patients with diabetic foot
disease is poorly understood.7-10 Clinicians are cautious about advising
extra activity to their patients with diabetic foot ulcers (DFU).
There is concern about excessive foot loading causing a delay with
healing of DFU because of repetitive moderate stress.11,12 However, the
published data regarding this association are not entirely clear.
Furthermore, there are few if any data evaluating the role of prolonged
low-grade pressure on healing. While walking on an unprotected wound
may be plausibly detrimental to healing, the role of exercise on health
benefits cannot be ignored, even in patients with DFU. Recent evidence
suggests that exercise causes a trend of increased joint mobility,
reduced psychological distress, and increased peripheral blood flow,
which might reduce the risk of falling and contribute in accelerating
wound healing.13-16 On the other hand, prolong immobilization of foot
may lead to deconditioning, muscle atrophy and weakness17,18 and
ultimately alter quality of life and wellbeing of patient even after
successful wound healing. Thus it stands to reason to mobilize foot and
encourage patients with DFU to be active and mobile. However, it is
unclear whether weight-bearing activities even with protective
offloading would suppress the impact of repetitive stress on plantar
wound and its negative impact on success of wound healing. Several
studies have explored the physical activity levels in individuals at
high risk for DFU.19-23 To our knowledge, none have explored activity
pattern including postures (i.e., sitting, standing, lying, walking) and
locomotion characteristics (e.g., number of taken steps, unbroken
walking bouts, walking speed, postural transition, etc.) in individuals
with DFU. Few studies suggested that exercise activity may have
positive effect on physiological (e.g., oxygen) and psychological
(e.g., stress) functioning and thus could enhance rates of wound
healing.15,24,25 However, none of these studies explored the effect of
physical activity pattern in patients with a DFU. Thus, there are no
standardized guidelines available to dose physical activity in this
population and clinicians are generally concerned about excessive
loading of the foot leading to poor wound healing outcomes.8 There
exists only a paucity of data (more specifically evidence from a single
randomized study) investigating the levels and profiles of physical
activity in this population.26 Therefore, the purpose of the present
study was to report the patterns of physical activity as a function of
removable and irremovable offloading modality in people with DFU.
Methods
Forty-nine eligible subjects
with confirmed diabetes and PN, age 18 or older with noninfected, non
ischemic, plantar neuropathic foot ulcers were entered into this
prospective randomized controlled trail. Subjects with major foot
amputation, active Charcot arthropathy, ankle brachial index (ABI) of
0.5 or less,27 history of alcohol or substance abuse within 6 months, or
unable to keep research appointments were excluded. If subjects had
noncompressible vessels (ABI > 1.2), we measured toe pressures to
determine a toe brachial index (TBI). A TBI > 0.65 was required for
enrollment. In addition, we excluded those patients, who could not be
accommodated in a standard removable cast walker or were unable to walk a
distance of minimum 20 minutes with or without an assistive device.
Subjects were recruited from 2 clinical sites including Hamad Medical Co
(HMC) in Doha, Qatar and the Southern Arizona Limb Salvage Alliance
(SALSA) clinic at the University of Arizona Health System, USA. The
study received local institutional review board (IRB) approval from the
University of Arizona and Hamad Medical Corporation. All subjects were
given written informed consent before recruitment. Using a computer
generated randomization list, participants were assigned to one of the
two off-loading modalities; removable cast walker (RCW, DH Offloading
Walker, Ossur, Reykjavik, Iceland) and instant total contact cast (iTCC,
the same RCW wrapped with a cohesive bandage, rendering it
irremovable; Figure 1).28,29 Sequentially numbered, opaque envelopes
that contained the study group assignment were provided to each site.
At the time of randomization, an envelope was opened by the study
coordinator to identify the study group assignment. All subjects
received standard of care including wound debridement and moisture
retentive dressings by a wound care specialist. This methodology was
described in previous studies.30,31 Subjects in RCW group were
instructed to cleanse the wound daily and apply a dressing. They were
instructed to inspect the wound at each dressing change and how to
detect signs that the wound is worsening. They were asked to report
these signs to the study coordinator immediately. Subjects in this
group were also instructed to only walk with the RCW in place and to
leave it on at all times. Subjects randomized to the iTCC group did not
have daily dressing changes due to the irremovable nature of the
device. Instead they received both written and oral instructions on
device care, bathing, and signs of cast deterioration. On weekly basis,
the iTCC was removed for the purpose of wound care and wound
assessment similar to subjects in the RCW group and reapplied at the
end of wound care and assessment. Outcomes including change in wound
size, wound closure, and daily physical activities were assessed at
baseline and then on weekly basis until wound healing or at 12 weeks,
whichever came first. The baseline was defined the first visit when
patient visited the wound clinic for the purpose of wound care. Wound
assessment included measurement of length, width, and depth of the
ulcer before and after debridement. If there was more than 1 ulcer, the
largest ulcer meeting all the inclusion and exclusion criteria was
enrolled. Other ulcers were treated in the same manner as the study
ulcer. We evaluated wounds at each clinical visit to ensure the absence
of infection. At each study visit the study coordinator took
photographs of the wound, which were planimetrically measured using a
3-D imaging system (Silhouette, ARANZ Systems, Christchurch, New
Zealand) and assessed by a clinician unaware of specific study
allocation. This provides measures of wound area, length and width. Pre
and post treatment photos were taken. Areas of new epithelium or
partial thickness ulceration were not included. We estimated changes in
wound area compared to previous visit wound size to estimate rate of
weekly wound healing. An ulcer was considered “healed” when it is fully
epithelialized with no drainage. Spontaneous daily physical activity
was monitored using a validated and an unobtrusive wearable sensor
(PAMSys™, BioSensics LLC, MA, USA; Figure 2)32 incorporated in a
comfortable shirt (PAMShirt™) worn by participants for 48 hours at
baseline and once every week for 48 hours until 12 weeks. Patient
adherence in wearing the PAMShirt™ was assessed based on measuring
acceleration fluctuation indicator of respiration as described in
earlier publication.23 Activity was quantified by percentage of each
main posture (i.e., sitting, standing, lying, and walking), total
number of steps, number of unbroken walking episode, gait speed, longest
unbroken episode of walking, number and duration of postural
transition (i.e., sit-to-stand and stand-to-sit) per day.32-34 To
examine whether the presence of DFU may limit spontaneous daily
physical activities in DPN patients, the results of this study was
retrospectively compared with our previous study23 in which similar
activity monitoring protocol was used to monitor 48-hour spontaneous
daily physical activities in 13 DPN patients without active ulcers
(age: 59 ± 8 years, BMI: 34.6 ± 4.2 kg/m2 ). Results are expressed as
mean ± standard deviation (SD). ANOVA and Fisher’s exact test (or
chi-square, as appropriate) was used to examine between-group
differences in descriptive data. Repeated measures ANOVA test was used
to examine between-group differences in weekly wound healing outcomes.
When a significant difference (defined as P < .050) was found the
Student–Newman–Keuls correction was used as the post hoc test to assess
pairwise comparisons. Spearman correlation coefficient was used to
examine correlation between activity characteristics and wound
outcomes. Logistic regression model (forward conditional) was used to
identify significant activities predictors to successful wound healing.
The person who analyzed the data was blind to the type of
intervention. The collected physical activity data were also compared
retrospectively with previously collected data7 from diabetic patients
without foot ulcers (n = 13, age: 59 ± 8, BMI: 34.6 ± 4.2) to examine
whether presence of foot ulcers may impact spontaneous daily physical
activities. Statistical analyses were performed using SPSS® version 20
(IBM, Armonk, NY, USA).
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