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Click on the pyramid for more about levels of evidence
LITERATURE SEARCH: Lower extremity pressure
injury prevention
Database(s) Searched: CINAHL
Search Strategy: CINAHL: (MH “Pressure Ulcer+”)
OR (MH “Heel Ulcer”) AND (MH “Lower
Extremity+”)
PubMed: ((“Skin Ulcer”[Mesh]) OR “Pressure
Ulcer”[Mesh]) AND “Lower Extremity”[Mesh] AND prevention
Search Date: December 17, 2021
Limits: English, last 4 years
Search results include citation and abstract only.
To request full text, email your selection(s) to library@baptisthealth.net.
1. for determining an optimal offloading design for treating and
preventing heel ulcers
Shaulian, H., Gefen, A., Solomonow-Avnon, D. and Wolf, A., Comput Biol Med 131 104261. (2021)
Diabetic heel ulceration, a serious, destructive, and costly complication of diabetes, is often treated by
custom-made offloading footwear. One common offloading device is a custom-made insole designed
with a hole under the damaged site that is intended to reduce local mechanical loads on the ulcer.
However, current devices do not take into account the increasing loads at the wound peripheries, and
quantitative assessments and scientific guidelines for the optimal design of the offloading hole are
lacking. Here, we develop a novel method to determine the volumetric exposure to mechanical loading
of a human heel, at two volume of interests (VOIs) during walking in 150 different finite-element
footwear configurations. We defined the two VOIs as (1) the area of the heel soft tissues typically at high
risk of ulceration, and (2) the soft tissues surrounding the high risk area. For all model variants, three
hole-geometry parameters were defined: (1) radius, (2) radius of curvature (ROC) and (3) depth. We
found two combinations of the offloading parameters which minimize heel loads in both VOIs. The first
is with a large offloading radius, large ROC and large depth, whereas the second is with a large
offloading radius, large depth but relatively small ROC. Our novel practical scientific analysis method,
that takes into account the ulcer site as well as the peripheral area, has the potential to optimize
development of offloading solutions by streamlining the examination of their biomechanical efficiency,
and thus may revolutionize prevention and treatment of diabetic ulcers at any foot location.
PMID: 33611128
Elevating care through discovery
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Link to article: https://www.ncbi.nlm.nih.gov/pubmed/33611128
2. Knee-High Devices Are Gold in Closing the Foot Ulcer Gap: A Review of Offloading Treatments to
Heal Diabetic Foot Ulcers
Lazzarini, P. A. and Jarl, G., Medicina (Kaunas) 57 (9): (2021)
Diabetic foot ulcers (DFU) are a leading cause of the global disease burden. Most DFUs are caused, and
prolonged, by high plantar tissue stress under the insensate foot of a person with peripheral
neuropathy. Multiple different offloading treatments have been used to try to reduce high plantar tissue
stress and heal DFUs, including bedrest, casting, offloading devices, footwear, and surgical procedures.
The best offloading treatments are those that balance the benefits of maximizing reductions in high
plantar tissue stress, whilst reducing the risks of poor satisfaction, high costs and potential adverse
events outcomes. This review aimed to summarize the best available evidence on the effects of
offloading treatments to heal people with DFUs, plus review their use in clinical practice, the common
barriers and solutions to using these treatments, and discuss promising emerging solutions that may
improve offloading treatments in future. Findings demonstrate that knee-high offloading devices, nonremovable or removable knee-high devices worn for all weight-bearing activities, are the gold standard
offloading treatments to heal most patients with DFU, as they are much more effective, and typically
safer, quicker, and cheaper to use compared with other offloading treatments. The effectiveness of
offloading treatments also seems to increase when increased offloading mechanical features are
incorporated within treatments, including customized insoles, rocker-bottom soles, controlled ankle
motion, and higher cast walls. However, in clinical practice these gold standard knee-high offloading
devices have low rates of prescription by clinicians and low rates of acceptance or adherence by
patients. The common barriers resulting in this low use seem to surround historical misperceptions that
are mostly dispelled by contemporary evidence. Further, research is now urgently required to close the
implementation gap between the high-quality of supporting evidence and the low use of knee-high
devices in clinical practice to reduce the high global disease burden of DFU in future.
Type of Article: Pilot study
PMID: 34577864
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/34577864
3. Cooling Intervention (MUSTCOOL) for Prevention of Lower Extremity Ulcer Recurrence: A
Randomized Controlled Trial
Kelechi, T. J., Madisetti, M., Prentice, M. and Mueller, M., J Wound Ostomy Continence Nurs 48 (3): 203-
210. (2021)
PURPOSE: The purpose of this study was to test our MUSTCOOL cooling patch intervention on the
incidence of venous leg (VLU) and diabetic foot ulcer (DFU) recurrence over a previously healed wound.
DESIGN: A 6-month randomized controlled trial. SUBJECTS AND SETTING: The target population was
individuals with previously healed ulcers receiving care in outpatient wound centers in the Southeastern
region of the United States. The sample comprised 140 individuals with recently healed ulcers; their
average age was 62.4 years (SD = 12 years); 86 (61.4%) were male; and 47 (33.6%) were Black or African
American. METHODS: Participants were randomized to the MUSTCOOL or placebo patch. Both groups
received instructions to apply the patch 3 times per week, and engage in standard of care including
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compression and leg elevation (VLU) or therapeutic footwear and hygiene (DFU). Demographic data
were collected at baseline, and incidence measures taken at 1, 3, and 6 months. We also studied
whether new ulcers developed on the adjacent leg or foot. Data were reported in
frequencies/percentages. RESULTS: One hundred seventeen participants (84%) were analyzed who
completed 6 months of study participation. Thirteen percent (9/69) and 17% (12/69) developed a
recurrent or new VLU, respectively; 29% (14/48) and 13% (6/48) developed a recurrent or new DFU,
respectively. One person in the DFU group developed both a recurrent and new ulcer. For 9 recurrent
VLUs, 6 (66.7%) recurred in the MUSTCOOL group and 3 (33.3%) receiving the placebo. Of the 15
recurrent DFUs (includes individual who developed both a recurrent and new ulcer), 10 (66.7%) recurred
in the MUSTCOOL group and 5 (33.3%) receiving the placebo. CONCLUSIONS: While the incidence of
ulcer recurrent was slightly higher in the MUSTCOOL group, this finding was not considered clinically
relevant. Overall ulcer recurrence during the 6-month study period was lower than reports in the
literature, the time frame in which recurrence rates are highest. TRIAL REGISTRATION: The study was
prospectively registered with ClinicalTrials.gov on December 10, 2015 (Identifier: NCT02626156)-
https://clinicaltrials.gov/ct2/show/NCT02626156.
Type of Article: Randomized Controlled Trial
PMID: 33735146
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/33735146
4. Effects of offloading devices on static and dynamic balance in patients with diabetic peripheral
neuropathy: A systematic review
Horstink, K. A., van der Woude, L. H. V. and Hijmans, J. M., Rev Endocr Metab Disord 22 (2): 325-335.
(2021)
Patients with diabetic peripheral neuropathy (DPN) usually have reduced somatosensory information
and altered perception in feet and ankles. Somatosensory information acts as feedback for movement
control and loss of somatosensation leads to altered plantar pressure patterns during gait and stance.
Offloading devices are used to reduce peak plantar pressure and prevent diabetic foot ulcers. However,
offloading devices can unfortunately have negative effects on static and dynamic balance. It is important
to investigate these unwanted effects, since patient with DPN already are at high risk of falling and
offloading devices could potentially increase this risk. The aim of this systematic review is to investigate
the effects of plantar offloading devices used for ulcer prevention on their role in static and dynamic
balance control in patients with DPN. PubMed and Embase were systematically searched using relevant
search terms. After title selection, abstract selection, and full-text selection only five articles could be
included for further analysis. Two articles included static balance measurements, two articles included
dynamic balance measurements, and one article included both. Results suggested that static balance
control is reduced when rocker bottom shoes and different insole configurations are used, however,
toe-only rockers showed less evidence for reduced static balance control. There was no evidence for
reduced dynamic balance control in combination with offloading devices. However, these results should
be interpreted with care, since the number of studies was very small and the quality of the studies was
moderate. Future research should evaluate balance in combination with different offloading devices, so
that clinicians subscribing them are more aware of their potential unwanted consequences.
Type of Article: Systematic Review
PMID: 33452959
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Link to article: https://www.ncbi.nlm.nih.gov/pubmed/33452959
5. Prevention of pressure injury in the operating room: Heels operating room pressure injury trial
Eberhardt, T. D., de Lima, S. B. S., de Avila Soares, R. S., Silveira, L., Rossarola Pozzebon, B., Reis, C. R.,
Dos Santos, K. P. P. and Alves, P. J. P., Int Wound J 18 (3): 359-366. (2021)
The objective was to evaluate the efficacy of multi-layered silicone foam (intervention) compared with
transparent polyurethane film (control) in preventing heel pressure injuries caused by surgical
positioning of individuals undergoing elective surgery. It was designed an intra-patient, open, parallel,
randomised controlled trial was conducted in a university hospital in southern Brazil, from March 2019
to February 2020, with patients undergoing elective surgeries of cardiac and gastrointestinal specialties.
The patients who met the selection criteria constituted, simultaneously, a single group receiving the
intervention and active control, through paired analysis of the cutaneous sites (right heel and left heel).
The outcome was the occurrence of PI, within the follow-up period was 72 hours. Brazilian Registry of
Clinical Trials: RBR-5GKNG5. There was analysis of 135 patients/270 heels, with an overall incidence of
36.7%. The pressure injury incidence was significantly lower in the intervention group (26.7%),
compared with the control group (P = .001); relative risk of 0.57. In the intervention group, the
estimated pressure injury-free time (survival) was 57.5 hours and in the control group, 43.9 hours. It was
concluded that (intervention) is more efficacious than transparent
polyurethane film (control) in the prevention of pressure injuries caused by surgical positioning of
individuals undergoing elective surgery.
Type of Article: Trial
PMID: 33314605
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/33314605
6. Nursing interventions for pressure injury prevention among critically ill patients: A systematic
review
Alshahrani, B., Sim, J. and Middleton, R., J Clin Nurs 30 (15-16): 2151-2168. (2021)
AIM: To systemically synthesise the evidence on the most effective nursing interventions to prevent
pressure injuries among critical care patients. BACKGROUND: Although pressure injury (PI) prevention is
a focus of nursing care in critical care units, hospital-acquired pressure injuries continue to occur in
these settings. DESIGN: A systematic review of literature guided by the Preferred Reporting Items for
Systematic Reviews and Meta-analyses (PRISMA) and Synthesis without meta-analysis (SWiM)
guidelines. METHODS: Four electronic databases were searched for relevant studies. Included studies
were screened and then critically appraised using the appropriate Joanna Briggs Institute appraisal tool.
Data were analysed and reported using a narrative synthesis. RESULTS: The review included 14 studies.
Randomised controlled trials, quasi-experimental, case series and cross-sectional studies were included.
The review identified four broad categories of interventions that are the most effective for preventing
pressure injuries: (a) PI prevention bundles, (b) repositioning and the use of surface support, (c)
prevention of medical device-related pressure injuries and (d) access to expertise. All the included
studies reported a reduction in pressure injuries following the interventions; however, the strength of
the evidence was rated from moderate to very low. CONCLUSIONS: Nurses are well qualified to lead in
the prevention of pressure injuries in critical care units. Every critically ill patient requires interventions
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to prevent pressure injuries, and the prevention of PIs should be considered a complex intervention.
Nurses must plan and implement evidence-based care to prevent all types of pressure injuries, including
medical device-related pressure injuries. Education and training programmes for nurses on PI
prevention are important for prevention of pressure injuries. RELEVANCE TO CLINICAL PRACTICE:
Nursing interventions should consist of evidence-based ‘bundles’ and be adapted to patients’ needs. To
prevent pressure injuries among critically ill patients, nurses must be competent and highly educated
and ensure fundamental strategies are routinely implemented to improve mobility and offload pressure.
Type of Article: Systematic Review
PMID: 33590917
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/33590917
7. Offloading for the Diabetic Foot: Considerations and Implications
Yalla, S. V., Crews, R. T., Patel, N. A., Cheung, T. and Wu, S., Clin Podiatr Med Surg 37 (2): 371-384. (2020)
Offloading the diabetic foot remains the major consideration for ulceration prevention and healing. This
narrative literature review presents a brief overview of current guidelines for offloading the diabetic
foot and discusses the implications that come with offloading treatment modalities and their effects on
the kinetic chain of the lower extremity. We also present the latest innovative studies from the Dr.
William M. Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine and Science
that advance the knowledge in this field and provide avenues for future research opportunities.
Type of Article: Literature Review
PMID: 32146989
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/32146989
8. Risk factors for developing heel ulcers for bedridden patients: A finite element study
van Zwam, W. G. H., van Turnhout, M. C. and Oomens, C. W. J., Clin Biomech (Bristol, Avon) 78 105094.
(2020)
BACKGROUND: The heel is one of the most common sites of pressure ulcers and the anatomical location
with the highest prevalence of deep tissue injury. Several finite element modeling studies investigate
heel ulcers for bedridden patients. In the current study we have added the implementation of the calf
structure to the current heel models. We tested the effect of foot posture, mattress stiffness, and a
lateral calcaneus displacement to the contact pressure and internal maximum shear strain occurring at
the heel. METHODS: A new 3D finite element model is created which includes the heel and calf
structure. Sensitivity analyses are performed for the foot orientation relative to the mattress, the
Young’s modulus of the mattress, and a lateral displacement of the calcaneus relative to the other soft
tissues in the heel. FINDINGS: The models predict that a stiffer mattress results in higher contact
pressures and internal maximum shear strains at the heel as well as the calf. An abducted foot posture
reduces the internal strains in the heel and a lateral calcaneus displacement increases the internal
maximum shear strains. A parameter study with different mattress-skin friction coefficients showed that
a coefficient below 0.4 decreases the maximum internal shear strains in all of the used loading
conditions. INTERPRETATION: In clinical practice, it is advised to avoid internal shearing of the calcaneus
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of patients, and it could be taken into consideration by medical experts and nurses that a more
abducted foot position may reduce the strains in the heel.
PMID: 32619872
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/32619872
9. Evaluating Dermisplus Prevent for the avoidance of development of medical device-related
pressure ulcers
Tyrer, J., Wounds UK 16 (1): 100-105. (2020)
Medical device-related pressure ulcers (MDRPUs) can be a key indicator of patient safety and nursing
quality in healthcare settings (Jackson et al, 2019). Preventing the development of this type of pressure
ulcer can be challenging since the medical device may be an essential part of the patient’s care and
treatment plan (Black and Kalowes, 2016). The use of silicone between the skin and the device has been
recommended as one method of reducing the risk of developing MDRPUs (Galetto et al, 2019). Aim: To
assess how well Dermisplus Prevent maintains skin integrity compared to the current product used.
Method: Twenty evaluation forms for Dermisplus Prevent were completed to assess its performance
against specific criteria. Results: The product was well reviewed when assessing pressure redistribution,
ease of use and patient comfort. All staff reported that the product performed better than or the same
as the current product used in practice. Conclusion: Dermisplus Prevent appears to be an effective and
cost-effective product to assist in the prevention of pressure ulcers, including MDRPUs.
Link to article:
https://search.ebscohost.com/login.aspx?direct=true&AuthType=ip,shib&db=ccm&AN=142081351&site
=ehost-live&custid=s8516683
10. Contact Pressures Between the Rearfoot and a Novel Offloading Insole: Results From a Finite
Element Analysis Study
Strayer, S. T., Moghaddam, S. R. M., Gusenoff, B., Gusenoff, J. and Beschorner, K. E., J Appl Biomech 1-8.
(2020)
Pressure offloading is critical to diabetic foot ulcer healing and prevention. A novel product has been
proposed to achieve this offloading with an insole that can be easily modified for each user. This insole
consists of pressurized bubbles that can be selectively perforated and depressurized to redistribute
weight to the nonulcer region of the foot. However, the effect of the insole design parameters, for
example, bubble height and stiffness, on offloading effectiveness is unknown. To this end, a 3-
dimensional finite element model was developed to simulate contact between the rearfoot and insole.
The geometry of the calcaneus bone and soft tissue was based on the medical images of an average
male patient, and material properties and loading conditions based on the values reported in the
literature were used. The model predicts that increasing bubble height and stiffness leads to a more
effectively offloaded region. However, the model also predicts that increasing stiffness leads to
increasing contact pressures on the surrounding soft tissue. Thus, a combination of insole design
parameters was determined, which completely offloads the desired region, while simultaneously
reducing the contact pressure on the surrounding soft tissue. This design is expected to aid in diabetic
foot ulcer healing and prevention.
PMID: 32736339
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Link to article: https://www.ncbi.nlm.nih.gov/pubmed/32736339
11. Stepease diabetic socks: An answer to efficacious indoor foot pressure relief- A prospective study
Soh, E. Z. F., Htwe, O., Naicker, A. S., Nasirabadi, A. R., Ghazali, M. J., Mohd Mustafah, N., Elamvazuthi, I.,
Yuliawiratman, B. S. and Naicker, M. S., J Tissue Viability 29 (2): 104-109. (2020)
BACKGROUND: Diabetic foot ulcer is commonly seen in people with diabetes mellitus. Inadequate
plantar pressure offloading has been identified as a contributing factor to development of diabetic foot
ulcers. Various pressure off-loading footwear are widely available in the market but poor compliance
has been reported especially for indoor usage. StepEase diabetic socks have been designed using
Ethylene Vinyl Acetate (EVA) microspheres for better redistribution of plantar pressure. The objective of
this study was to determine the efficacy of StepEase in redistributing the foot plantar pressure and to
assess patients’ satisfaction on the usage of the socks. METHODS: This was a prospective non
randomized clinical trial conducted on 31 patients with diabetes mellitus with high risk foot (King’s
classification stage II) over a 12 weeks period. Dynamic foot plantar pressure reading was recorded at
day 0, 6 weeks and 12 weeks intervals, both barefoot and with StepEase, system
(Novel GmbH, Munich, Germany). Patients’ satisfaction and usage practice were assessed by a
questionnaire. RESULTS: The mean age of subjects was 57.9 years with mean body mass index (BMI) of
26 kg/m(2). The mean duration of diagnosis with diabetes mellitus was 10.2 years. The mean peak
plantar pressure was found to be highest at the right forefoot and left heel region, 267.6 kPa (SD113.5
kPa) and 266.3 kPa (SD 94.6 kPa) respectively. There was a statistically significant reduction of mean
peak pressure (P < 0.0001 to P = 0.024) in all masked regions except the left toe region ranging from
22.3 to 47.5% (53.2-117.4 kPa). The highest reduction was seen in the right toe region (47.5%). The
reduction of peak pressure was still significant (P < 0.0001 to P = 0.034) at 6 weeks ranging from 24.7%
to 46.8% (46.1-100.6 kPa) and at 12 weeks, which was 22.2-49.2% (40.6-91.9 kPa). Mean usage of the
socks was 4.39 days per week (SD 1.82), with the mode of 4-6 h per day. Most of the subjects were
satisfied or very satisfied with the StepEase socks (77.4%) while 87.1% agreed to continue using the
socks. None had any new ulcer development or fall during the study period. CONCLUSION: StepEase was
significantly effective as an indoor foot pressure relieving footwear. It resulted in significant peak plantar
pressure reduction by up to 49.2% and the effect was maintained for at least 12 weeks duration.
PMID: 32014382
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/32014382
12. Heel Pressure Injuries: Consensus-Based Recommendations for Assessment and Management
Rivolo, M., Dionisi, S., Olivari, D., Ciprandi, G., Crucianelli, S., Marcadelli, S., Zortea, R. R., Bellini, F.,
Martinato, M., Gabrielli, A. and Pomponio, G., Adv Wound Care (New Rochelle) 9 (6): 332-347. (2020)
Significance: A systematic approach to develop experts-based recommendations could have a favorable
impact on clinical problems characterized by scarce and low-quality evidence as heel pressure ulcers.
Recent Advances: A systematic approach was used to conduce a formal consensus initiative. A
multidisciplinary panel of experts identified relevant clinical questions, performed a systematic search of
the literature, and created a list of statements. GRADE Working Group guidelines were followed. An
independent international jury reviewed and voted recommendations for clinical practice. Consent was
developed according to Delphi rules and GRADE method was used to attribute grade of strength. Critical
Issues: The extensive search of the literature retrieved 42 pertinent articles (26 clinical studies, 7
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systematic reviews or meta-analysis, 5 other reviews, 2 consensus-based articles, and 2 in vitro studies).
Thirty-five recommendations and statements were created. Only 1 of 35, concerning ankle-brachial
pressure index reliability in diabetic patients, was rejected by the panel. No sufficient agreement was
achieved on toe brachial index test to rule out the orphan heel syndrome, removing dry eschar in adult
patients without vascular impairment, and using an antimicrobial dressing in children with infected heel
pressure injuries. Eleven recommendations were approved with a weak grade of strength. Experts
strongly endorsed 20 recommendations. Offloading, stages I and II pressure injuries, and referral criteria
were areas characterized by higher level of agreement. Future Directions: We believe that the results of
our effort could improve practice, especially in areas where clear and shared opinions emerged. Barriers
and limits that could hinder implementation are also discussed in the article.
Type of Article: Review
PMID: 32286202
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/32286202
13. Comparison of two pixelated insoles using in-shoe pressure sensors to determine percent
offloading: case studies
Penny, H., Tran, S., Sansosti, L., Pettineo, S., Bloom, A., Qureshi, R., Bickers, D., Kreuz, E., Zaki, P. and
McGuire, J., J Wound Care 29 (Sup2c): S18-S26. (2020)
OBJECTIVE: The gold standard for offloading neuropathic forefoot and midfoot wounds is the total
contact cast (TCC). However, in practice TCC is rarely used and is contraindicated in patients with
fluctuating oedema, poor perfusion, lack of adequate tissue oxygenation and morbid obesity. It can also
be too restrictive for patients, inevitably resulting in treatment rejection and delayed healing. This paper
examines the role of shoe-based offloading devices as an alternative in reducing plantar pressure and
optimising the healing of neuropathic ulcers. METHOD: Healthy subjects were recruited and fitted for
two types of pixelated insoles: PegAssist (PA) insole system (Darco International, US) and FORS-15
(FORS) offloading insole (Saluber, Italy). An area of discreet, elevated high pressure was created by
adding a to the plantar skin under the first metatarsal head. Subjects walked
barefoot in surgical shoes with standard insoles (Condition 1), barefoot in pixelated insoles (Condition
2), barefoot with pixels removed (Condition 3). Dynamic plantar pressures were
and the results were analysed to determine plantar pressure changes in each condition. RESULTS: Using
PA, the percentage reduction of plantar pressure (kPa) under the first metatarsal between Condition 1
and Condition 2 was 10.54+/-15.81% (p=0.022), between Condition 2 and Condition 3 was 40.13+/-
11.11% (p<0.001), and between Condition 1 and Condition 3 was 46.67+/-12.95 % (p<0.001). Using
FORS, the percentage reduction between Condition 1 and Condition 2 was 24.25+/-23.33% (p=0.0029),
between Condition 2 and Condition 3 was 23.61+/-19.45% (p<0.001), and between Condition 1 and
Condition 3 was 43.39+/-18.70% (p<0.001). A notable difference in the findings between the two insoles
was the presence of a significant edge effect associated with PA, indicating that the offloading was not
entirely successful. No edge effect was detected with FORS. CONCLUSION: Our current analysis shows
that pixelated insoles exhibit potential for supplemental offloading in surgical shoes. These devices
could provide an alternative way for physicians to offload plantar wounds and expedite closure for
patients that cannot tolerate a TCC or other restrictive devices.
Type of Article: Case study
PMID: 32058841
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Link to article: https://www.ncbi.nlm.nih.gov/pubmed/32058841
14. Effects of Multilayer Silicone Foam Dressings for the Prevention of Pressure Ulcers in High-Risk
Patients: A Randomized Clinical Trial
Oe, M., Sasaki, S., Shimura, T., Takaki, Y. and Sanada, H., Adv Wound Care (New Rochelle) 9 (12): 649-
656. (2020)
Objective: To determine whether multilayer silicone foam dressings can prevent pressure ulcers arising
in the sacrum and coccyx of patients with persistent severe diarrhea and/or fragile skin. Approach: This
randomized, 14-day controlled trial included 600 hospitalized patients with persistent severe diarrhea
and/or fragile skin who were at high risk of developing pressure ulcers. All participants were enrolled
from three Japanese institutions. Participants meeting all inclusion and exclusion criteria were
randomized using the Excel program to receive standard care (control; n = 300) recommended by
Japanese guidelines or multilayer silicone foam dressings applied to the sacrum and coccyx
(intervention; n = 300). Results: Significantly more participants in the control than the intervention
group developed pressure ulcers (22 vs. 5, p = 0.001). Innovation: The incidence of pressure ulcers
remains high in hospitalized patients at high risk of developing pressure ulcers. The present findings
might contribute to novel preventive strategies for patients at high risk of developing pressure ulcers.
Conclusion: Multilayer silicone foam dressings can prevent pressure ulcers of the sacrum and coccyx in
patients with persistent severe diarrhea and/or fragile skin.
Type of Article: Randomized Controlled Trial
PMID: 33124968
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/33124968
15. The effectiveness of two silicone dressings for sacral and heel pressure ulcer prevention compared
with no dressings in high-risk intensive care unit patients: a randomized controlled parallel-group trial
Hahnel, E., El Genedy, M., Tomova-Simitchieva, T., Hauss, A., Stroux, A., Lechner, A., Richter, C., Akdeniz,
M., Blume-Peytavi, U., Lober, N. and Kottner, J., Br J Dermatol 183 (2): 256-264. (2020)
BACKGROUND: There is a high incidence of pressure ulcers in high-risk settings such as intensive care.
There is emerging evidence that the application of dressings to pressure ulcer predilection areas (sacrum
and heels) improves prevention strategies. OBJECTIVES: To determine whether preventive dressings,
applied to the sacrum and heels of high-risk patients in intensive care units, in addition to standard
prevention, reduces the incidence of pressure ulcers. METHODS: Between June 2015 and July 2018, a
randomized, controlled, two-arm, superiority pragmatic study was performed with a concealed 1 : 1
allocation to the intervention and control group. Patients assigned to the intervention group had
dressings applied to the sacrum and heels. RESULTS: In total, 7575 patients were screened for eligibility
and 475 patients were included and allocated to both groups. Finally, 212 patients in the intervention
group and 210 in the control group were analysed. The mean age was 63.5 years and the majority of
patients were male (65.4%). The cumulative pressure ulcer incidence category II and above was 2.8% in
the intervention, and 10.5% in the control group (P = 0.001). Compared with the control group, the
relative risk in the intervention group was 0.26 [95% confidence interval (CI) 0.11-0.62] and the absolute
risk reduction was 0.08 (95% CI 0.03-0.13). CONCLUSIONS: The results indicate that the application of
dressings, in addition to standard prevention, in high-risk intensive care unit patients is effective in
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preventing pressure ulcers at the heels and sacrum. What’s already known about this topic? Pressure
ulcers are severe soft tissue injuries and wounds, which occur worldwide in all healthcare settings.
Despite preventive interventions, pressure ulcers still develop. There is emerging evidence that
dressings help to prevent pressure ulcers. What does this study add? The incidence of pressure ulcers in
intensive care units among high-risk patients remains high. The application of dressings to the sacrum
and heels, in addition to standard preventive measures, reduces the relative and absolute risks for the
development of pressure ulcers. The application of preventive dressings at the heels and sacrum seems
to be feasible in intensive care settings.
Type of Article: Randomized Controlled Trial
PMID: 31628863
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/31628863
16. Deal with heels: a pressure ulcer prevention initiative
Birkill, K., Br J Community Nurs 25 (3): S6-S10. (2020)
Pressure ulcers/injuries are well known for being a common problem in healthcare and are a key
indicator of the quality and experience of patient care. This article discusses how one NHS trust reduced
the incidence of heel pressure ulcers within adult inpatient settings. In 2016/17, the trust identified 14
avoidable category 3 and above pressure ulcers/injuries in inpatient settings, of which 10 had developed
on the heels. Through root cause analysis, the organisation identified themes, which prompted action,
and a quality improvement project ‘Deal with heels’ was planned and implemented. Changes were
introduced through a collaborative and structured approach; the key stakeholders included the tissue
viability team, procurement, medical devices, patient safety, managers, matrons, ward sisters and tissue
viability link advisors, who worked together to reduce heel ulcer prevalence through education and
standardised practice. As a result of improved organisational awareness and some changes, the number
of heel pressure ulcers/injuries reduced to two over a 3-year period, which also helped reduce the total
number of avoidable pressure ulcers/injuries.
PMID: 32160061
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/32160061
17. Meta-analyses of randomized controlled trials reporting the effect of home foot temperature
monitoring, patient education or offloading footwear on the incidence of diabetes-related foot ulcers
Alahakoon, C., Fernando, M., Galappaththy, C., Matthews, E. O., Lazzarini, P., Moxon, J. V. and Golledge,
J., Diabet Med 37 (8): 1266-1279. (2020)
AIM: The aim of this study was to perform an up-to-date systematic review and meta-analysis of
randomized controlled trials (RCTs) examining the efficacy of home foot temperature monitoring,
patient education and offloading footwear in reducing the incidence of diabetes-related foot ulcers.
METHODS: A literature search was performed using MEDLINE, PubMed, CINAHL, Scopus and Cochrane
databases to identify relevant original studies. Meta-analyses were performed using intention-to-treat
principals for worst (main analysis) and best (sub-analysis) case scenarios. Leave-one-out sensitivity
analyses were used to assess the consistency of findings. RESULTS: Of 7575 unique records, 17 RCTs
involving 2729 participants were included. Four tested home foot temperature monitoring (n = 468), six
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examined patient education (n = 823) and seven assessed offloading footwear (n = 1438). Participants’
who performed home foot temperature monitoring [odds ratio (OR) 0.51, 95% confidence interval (CI)
0.31 to 0.84; n = 468] and those provided offloading footwear (OR 0.48, 95% CI 0.29 to 0.80; n = 1438)
were less likely to develop a diabetes-related foot ulcer. Patient education programmes did not
significantly reduce diabetes-related foot ulcer incidence (OR 0.59, 95% CI 0.29 to 1.20; n = 823).
Sensitivity analyses suggested that offloading footwear findings were consistent, but home foot
temperature findings were dependent on the individual inclusion of one trial. All RCTs had either high or
unclear risk of bias. CONCLUSION: This meta-analysis suggests that offloading footwear is effective in
reducing the incidence of diabetes-related foot ulcers. Home foot temperature monitoring also appears
beneficial but larger trials are needed (PROSPERO registration no.: CRD42019135226).
Type of Article: Systematic Review
PMID: 32426872
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/32426872
18. Modifiable patient-related factors associated with pressure ulcers on the sacrum and heels:
Secondary data analyses
Manderlier, B., Van Damme, N., Verhaeghe, S., Van Hecke, A., Everink, I., Halfens, R. and Beeckman, D., J
Adv Nurs 75 (11): 2773-2785. (2019)
AIM: To explore factors associated with the presence of category I-IV pressure ulcers on the sacrum and
heels. DESIGN: Cross-sectional, secondary data analysis using data collected from the Landelijke
Prevalentiemeting Zorgproblemen (LPZ) project, a multicentre prevalence study including nursing home
residents and community care clients (N = 4,842) in the Netherlands in 2017. METHODS: A single binary
logistic regression model was designed to identify factors associated with the presence of pressure
ulcers. Additionally, a multiple binary logistic regression model including modifiable explanatory factors
associated with the presence of pressure ulcers was designed. RESULTS: Impaired mobility, friction and
shear (evaluated using the Braden Scale) are significantly associated with the presence of both sacral
and heel category I-IV pressure ulcers. Incontinence-associated dermatitis is significantly associated with
category I-IV sacral pressure ulcers. CONCLUSION: In pressure ulcer prevention, nursing interventions
should focus on frequent repositioning and mobilization while avoiding exposure of the skin to friction
and shear. The need to consider incontinence-associated dermatitis, incontinence and moisture as
important factors in pressure ulcer risk assessment is confirmed. IMPACT: Pressure ulcers occur when
skin and tissues are deformed between bony prominences and the support surface in a sitting or lying
position. They are the result of a complex interaction between direct causal factors and a wide range of
indirect factors. Recognition of these factors influences risk assessment guidance and practice.
Knowledge of skin-specific factors at the patient level, modifiable by nursing interventions, enables a
better targeted and tailored preventive approach.
Type of Article: Multicenter Study
PMID: 31287188
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/31287188
19. Clinical efficacy of therapeutic footwear with a rigid rocker sole in the prevention of recurrence in
patients with diabetes mellitus and diabetic polineuropathy: A randomized clinical trial
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Lopez-Moral, M., Lazaro-Martinez, J. L., Garcia-Morales, E., Garcia-Alvarez, Y., Alvaro-Afonso, F. J. and
Molines-Barroso, R. J., PLoS One 14 (7): e0219537. (2019)
BACKGROUND: Therapeutic footwear becomes the first treatment line in the prevention of diabetic foot
ulcer and future complications of diabetes. Previous studies and the International Working Group on the
Diabetic Foot have described therapeutic footwear as a protective factor to reduce the risk of reulceration. In this study, we aimed to analyze the efficacy of a rigid rocker sole to reduce the recurrence
rate of plantar ulcers in patients with diabetic foot. METHODS: Between June 2016 and December 2017,
we conducted a randomized controlled trial in a specialized diabetic foot unit. PARTICIPANTS AND
INTERVENTION: Fifty-one patients with diabetic neuropathy who had a recently healed plantar ulcer
were randomized consecutively into the following two groups: therapeutic footwear with semi-rigid sole
(control) or therapeutic footwear with a rigid rocker sole (experimental). All patients included in the
study were followed up for 6 months (one visit each 30 +/- 2 days) or until the development of a
recurrence event. MAIN OUTCOME AND MEASURE: Primary outcome measure was recurrence of ulcers
in the plantar aspect of the foot. FINDINGS: A total of 51 patients were randomized to the control and
experimental groups. The median follow-up time was 26 [IQR-4.4-26.1] weeks for both groups. On an
intention-to-treat basis, 16 (64%) and 6 (23%) patients in the control and experimental groups had ulcer
recurrence, respectively. Among the group with >60% adherence to therapeutic footwear, multivariate
analysis showed that the rigid rocker sole improved ulcer recurrence-free survival time in diabetes
patients with polyneuropathy and DFU history (P = 0.019; 95% confidence interval, 0.086-0.807; hazard
ratio, 0.263). CONCLUSIONS: We recommend the use of therapeutic footwear with a rigid rocker sole in
patients with diabetes with polyneuropathy and history of diabetic foot ulcer to reduce the risk of
plantar ulcer recurrence. TRIAL REGISTRATION: ClinicalTrials.gov NCT02995863.
Type of Article: Randomized Controlled Trial
PMID: 31295292
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/31295292
20. Refining Heel Pressure Injury Risk Factors in the Hospitalized Patient
Delmore, B., Ayello, E. A., Smith, D., Rolnitzky, L. and Chu, A. S., Adv Skin Wound Care 32 (11): 512-519.
(2019)
OBJECTIVE: To replicate previous research that found four independent and significant predictors of heel
pressure injuries (HPIs) in hospitalized patients using a larger and more diverse patient population.
METHODS: Researchers conducted a retrospective, case-control study with a main and a validation
analysis (N = 1,937). The main analysis had 1,697 patients: 323 patients who had HPIs and 1,374 who did
not. The validation analysis had 240 patients: 80 patients who developed HPIs and 160 who did not.
Researchers used a series of diagnosis codes to define variables associated with an HPI. Data were
extracted from the New York Statewide Planning and Research Cooperative System for January 2014 to
June 2015. Study authors conducted a series of forward stepwise logistic regression analyses for both
samples to select the variables that were significantly and independently associated with the
development of an HPI in a multivariable setting. Researchers generated a receiver operating
characteristic curve using the final model to assess the regression model’s ability to predict HPI
development. RESULTS: Seven variables were significant and independent predictors associated with
HPIs: diabetes mellitus, vascular disease, perfusion issues, impaired nutrition, age, mechanical
ventilation, and surgery. The receiver operating characteristic curve demonstrated predictive accuracy
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of the model. CONCLUSIONS: Beyond a risk assessment scale, providers should consider other factors,
such as comorbidities, which can predispose patients to HPI development.
PMID: 31498171
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/31498171
21. Conservative Offloading
Crisologo, P. A., Lavery, L. A. and Fontaine, J., Clin Podiatr Med Surg 36 (3): 371-379. (2019)
The etiology of ulcerations in diabetes mellitus is associated with the presence of peripheral 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. 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. Offloading is the mainstay of healing
neuropathic ulcers.
Type of Article: Review
PMID: 31079604
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/31079604
22. Lateral pressure equalisation as a principle for designing support surfaces to prevent deep tissue
pressure ulcers
Boyle, C. J., Carpanen, D., Pandelani, T., Higgins, C. A., Masen, M. A. and Masouros, S. D., PLoS One 15
(1): e0227064. (2019)
When immobile or neuropathic patients are supported by beds or chairs, their soft tissues undergo
deformations that can cause pressure ulcers. Current support surfaces that redistribute under-body
pressures at vulnerable body sites have not succeeded in reducing pressure ulcer prevalence. Here we
show that adding a supporting lateral pressure can counter-act the deformations induced by under-body
pressure, and that this ‘pressure equalisation’ approach is a more effective way to reduce ulcer-inducing
deformations than current approaches based on redistributing under-body pressure. A finite element
model of the seated pelvis predicts that applying a lateral pressure to the soft tissue reduces peak von
Mises stress in the deep tissue by a factor of 2.4 relative to a standard cushion (from 113 kPa to 47 kPa)-
a greater effect than that achieved by using a more conformable cushion, which reduced von Mises
stress to 75 kPa. Combining both a conformable cushion and lateral pressure reduced peak von Mises
stresses to 25 kPa. The ratio of peak lateral pressure to peak under-body pressure was shown to
regulate deep tissue stress better than under-body pressure alone. By optimising the magnitude and
position of lateral pressure, tissue deformations can be reduced to that induced when suspended in a
fluid. Our results explain the lack of efficacy in current support surfaces and suggest a new approach to
designing and evaluating support surfaces: ensuring sufficient lateral pressure is applied to counter-act
under-body pressure.
PMID: 31899778
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/31899778
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23. Effects of ambient conditions on the risk of pressure injuries in bedridden patients-multi-physics
modelling of microclimate
Zeevi, T., Levy, A., Brauner, N. and Gefen, A., Int Wound J 15 (3): 402-416. (2018)
Scientific evidence regarding microclimate and its effects on the risk of pressure ulcers (PU) remains
sparse. It is known that elevated skin temperatures and moisture may affect metabolic demand as well
as the mechanical behaviour of the tissue. In this study, we incorporated these microclimate factors into
a novel, 3-dimensional multi-physics coupled model of the human buttocks, which simultaneously
determines the biothermal and biomechanical behaviours of the buttocks in supine lying on different
support surfaces. We compared 3 simulated thermally controlled mattresses with 2 reference foam
mattresses. A tissue damage score was numerically calculated in a relevant volume of the model, and
the cooling effect of each 1 degrees C decrease of tissue temperature was deduced. Damage scores of
tissues were substantially lower for the non-foam mattresses compared with the foams. The percentage
tissue volume at risk within the volume of interest was found to grow exponentially as the average
tissue temperature increased. The resultant average sacral skin temperature was concluded to be a
good predictor for an increased risk of PU/injuries. Each 1 degrees C increase contributes approximately
14 times as much to the risk with respect to an increase of 1 mmHg of pressure. These findings highlight
the advantages of using thermally controlled support surfaces as well as the need to further assess the
potential damage that may be caused by uncontrolled microclimate conditions on inadequate support
surfaces in at-risk patients.
PMID: 29250903
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/29250903
24. Effect of different casting design characteristics on offloading the diabetic foot
Westra, M., van Netten, J. J., Manning, H. A., van Baal, J. G. and Bus, S. A., Gait Posture 64 90-94. (2018)
BACKGROUND: Non-removable knee-high devices, such as a total contact cast (TCC), are recommended
for offloading diabetic plantar forefoot ulcers. However, it is insufficiently known how each of the
different design characteristics of these devices contribute to offloading the diabetic foot. RESEARCH
QUESTION: What is the offloading effect of the different design characteristics that make up a nonremovable knee-high cast for people with diabetes and active or previous plantar forefoot ulcers?
METHODS: Sixteen persons with diabetes, peripheral neuropathy and a healed or active plantar forefoot
ulcer had their plantar pressures measured during walking in a non-removable knee-high device (TCC),
in that device made removable (BTCC), in that device made below-ankle (cast shoe), in that cast shoe
worn with a different walking sole and in a newly made cast shoe without a custom-moulded footdevice interface. Peak pressures, force-time integral, and perceived walking comfort were assessed.
RESULTS: Compared with the BTCC, peak pressures in the TCC were 47% (P=0.028), 26% (P=0.003) and
15% (P=0.050) lower at the hallux, midfoot and (previous) ulcer location, respectively. Compared to the
cast shoe, peak pressures in the BTCC were 39-43% and 47% (both P<0.001) lower in the forefoot
regions and (previous) ulcer location, respectively. The total force-time integral was 21% and 11%
(P<0.007) lower in the TCC and BTCC compared to the cast shoe. Perceived walking comfort was 5.6 in
the TCC and 6.5 in the BTCC (P=0.037). Effects of the other design characteristics (i.e. walking sole and
plantar moulding) were non-significant. SIGNIFICANCE: The TCC gives superior offloading, mostly
because of being a knee-high and non-removable device, providing an optimal ‘shaft effect’. The TCC
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does, however, negatively affect walking comfort. These results aid decision-making in offloading
diabetic plantar forefoot ulcers.
Type of Article: Review
PMID: 29890399
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/29890399
25. Comparing the effects of 3 different pressure ulcer prevention support surfaces on the structure
and function of heel and sacral skin: An exploratory cross-over trial
Tomova-Simitchieva, T., Lichterfeld-Kottner, A., Blume-Peytavi, U. and Kottner, J., Int Wound J 15 (3):
429-437. (2018)
Special support surfaces are key in pressure ulcer prevention. The aim of this study was to measure the
effects of 3 different types of mattresses (reactive gel, active alternating air, basic foam) on skin
properties of the sacral and heel skin after 2 hours loading. Fifteen healthy females (median age 66
years) were included. Transepidermal water loss, skin surface temperature, erythema, stratum corneum
hydration, epidermal hydration, skin extensibility, elastic function, and recovery as well as skin
roughness parameters were measured under controlled room conditions before loading, immediately
after loading, and 20 minutes post-loading in the supine position on the different mattresses. The
highest increases in transepidermal water loss, skin temperature, and erythema were observed for the
foam mattress after loading, indicating higher deformation and occlusion. Cutaneous stiffness decreased
in all 3 groups, indicating structural changes during loading. There was a substantial decrease of mean
roughness at the heel skin in the foam group, leading to a flattening of the skin surface. Study results
indicate that the type of support surface influences skin structure and function during loading. The gel
and air mattress appeared to be more protective compared with the foam mattress, but the differences
between the gel and air were minor.
Type of Article: Comparative Study
PMID: 29277963
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/29277963
26. Measuring the impact of cushion design on buttocks tissue deformation: An MRI approach
Sonenblum, S. E., Ma, J., Sprigle, S. H., Hetzel, T. R. and McKay Cathcart, J., J Tissue Viability 27 (3): 162-
172. (2018)
AIM: To establish a research approach for describing how different wheelchair cushion designs impact
buttocks tissue deformation during sitting. MATERIALS AND METHODS: The buttocks of 4 individuals
with spinal cord injury and significant atrophy were scanned sitting in a FONAR Upright MRI. Scans were
collected with the individuals’ buttocks fully suspended without pelvic support, and seated on 3
different commercially available wheelchair cushions. Multi-planar scans were analyzed to provide 3D
renderings and measurements of tissue thickness and shape. RESULTS: Bulk tissue thicknesses at the
ischium, which rarely included muscle, were reduced by more than 60% on enveloping cushion designs
studied (i.e., Roho HP and Matrx Vi), and more variably (23-60%) on an orthotic off-loading design (i.e.,
Java). Adipose was typically displaced posterior and superior from the unloaded condition, with more
lateral displacement on the Roho HP and Matrx Vi and more medial displacement present on the Java.
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Large changes in angle at the sacro-coccygeal joint indicated significant loading on the region.
Deformation at the greater trochanter was more consistent across surfaces. Greater interface pressures
tended to be associated with greater deformation, but the relationship varied by individuals and was
highly non-linear. CONCLUSIONS: The buttocks in this study all deformed significantly, but at different
locations and in different manners across all 3 surfaces. Attention needs to be paid to the regions of
greatest deformation. A future metric of shape compliance should consider cushion performance at all
high risk regions, and changes to the amount and shape of tissue in the regions of interest.
PMID: 29804800
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/29804800
27. A Computer Modeling Study to Assess the Durability of Prophylactic Dressings Subjected to
Moisture in Biomechanical Pressure Injury Prevention
Schwartz, D., Levy, A. and Gefen, A., Ostomy Wound Manage 64 (7): 18-26. (2018)
The sacral area is the most common site for pressure injuries (PIs) associated with prolonged supine
bedrest. In previous studies, an anisotropic multilayer prophylactic dressing was found to reduce the
incidence of PIs and redistribute pressure. The purpose of the current study was to further investigate
relationships between design features and biomechanical efficacy of sacral prophylactic dressings. Using
computer modeling, the anisotropic multilayer dressing and a hypothetical dressing with different
mechanical properties were tested under dry and 3 levels of moist/wet conditions. Sixteen (16) finite
element model variants representing the buttocks were developed. The model variants utilized slices of
the weight-bearing buttocks of a 28-year-old healthy woman for segmentation of the pelvic bones and
soft tissues. Effective stresses and maximal shear stresses in a volume of interest of soft tissues
surrounding the sacrum were calculated from the simulations, and a protective endurance (PE) index
was further calculated. Resistance to deformations along the direction of the spine when wet was
determined by rating simulation outcomes (volumetric exposures to effective stress) for the different
dressing conditions. Based on this analysis, the anisotropic multilayer prophylactic dressing exhibited
superior PE (80%), which was approximately 4 times that of the hypothetical dressing (22%). This study
provides additional important insights regarding the optimal design of prophylactic dressings, especially
when exposed to moisture. A next step in research would be to optimize the extent of the anisotropy,
particularly the property ratio of stiffnesses (elastic moduli).
Type of Article: Computer modeling study
PMID: 30059336
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/30059336
28. Mitigating the damaging effects of tissue distortions by using a low-friction heel protector
Schofield, A., Br J Nurs 27 (Sup12): S27-S34. (2018)
This article reports the finding of a small non-controlled evaluation over a 2-week period in three
different care settings: a residential care home, an acute stroke unit and a community intermediate care
hospital. At initial recruitment 30 patients were identified by clinical assessment as being at high risk of
developing a heel pressure ulcer. Further inclusion criteria were identifying heels that had signs of
pressure damage occurring, blanching and non-blanching erythema, blistering and category 2 ulceration.
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In all, 15 patients fully completed the evaluation over a 14-day period. The mean age was 86 years. The
low-friction bootee was worn constantly while in bed and seated in chairs, only being removed for heel
checks and hygiene care. No patients were independently mobile during the evaluation; products were
not worn to walk in due to a risk of falling-patients in the community hospital who had to mobilise for
rehabilitation removed the bootees for this activity. All had pressure mapping and ultrasound of pedal
pulses prior and after evaluation by the tissue viability specialist nurse. Results of pressure mapping
showed a reduction of peak heel pressures on application of the bootees and a final review of reduction
in visual signs of heel damage, reduced pain, increased comfort and ease of use. These results indicate
that a standardised care pathway approach to heel protection using low-friction heel bootees is
effective in all care settings for the reduction and prevention of heel pressure damage.
Type of Article: Clinical Trial
PMID: 29944428
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/29944428
29. Assessment and consideration of foot risk factors is essential for proactive prevention of hospitalacquired foot pressure injuries
Scheepers, J., Wounds International 9 (1): 29-34. (2018)
The research outlined in this article aimed to see if high-risk feet were also identified as ‘at risk of
ulceration’ by the Braden Score. One-hundred-and-thirty-two patients had foot risk stratified by a
podiatrist and their admission Braden pressure injury (PI) risk level was compared. Only 36% were
decreed to be at the same level of risk by both methods. The lack of agreement was demonstrated by a
very low Kappa score. The Braden score underestimated PI risk to feet for 52% of the study population.
Therefore, the authors concluded that less reliance on the Braden score is needed for the
implementation of prevention to reduce rates hospital-acquired foot PIs.
Link to article:
https://search.ebscohost.com/login.aspx?direct=true&AuthType=ip,shib&db=ccm&AN=128352825&site
=ehost-live&custid=s8516683
30. A randomised controlled trial of the clinical effectiveness of multi-layer silicone foam dressings for
the prevention of pressure injuries in high-risk aged care residents: The Border III Trial
Santamaria, N., Gerdtz, M., Kapp, S., Wilson, L. and Gefen, A., Int Wound J 15 (3): 482-490. (2018)
Pressure injuries are prevalent in highly dependent aged care residents. This study investigated the
clinical effectiveness of the application of the Mepilex Border Sacrum and Mepilex Heel dressings to
prevent the development of facility-acquired pressure injuries. A total of 288 recently admitted
residents were enrolled from 40 Australian nursing homes into a randomised controlled trial. Residents
randomised to standard care (n = 150) received pressure injury prevention as recommended by
international guidelines. Residents randomised to the intervention (n = 138) received standard pressure
injury prevention care and had dressings applied to their sacrum and heels. Participants were
comparable on demographic and physiological parameters. More residents in the control group
developed pressure injuries than in the intervention group (16 vs 3, P = 0.004), and they developed
more pressure injuries in total than residents in the intervention group. The results represent a relative
risk reduction of 80% for residents treated with the dressings and for every 12 patients that we treated
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we prevented one pressure injury. Based on our findings, we conclude that the use of the Molnlycke
Mepilex Border Sacrum and Mepilex Heel dressings confers a significant additional protective benefit to
nursing home residents with a high risk of developing a facility-acquired pressure injury.
Type of Article: Randomised controlled trial
PMID: 29635842
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/29635842
31. Do Prophylactic Foam Dressings Reduce Heel Pressure Injuries?
Ramundo, J., Pike, C. and Pittman, J., J Wound Ostomy Continence Nurs 45 (1): 75-82. (2018)
PURPOSE: The purpose of this evidence-based report card is to examine the evidence and provide
recommendations related to the effectiveness of prophylactic foam dressings in reducing heel pressure
injuries. QUESTION: Do prophylactic foam dressings applied to the heel reduce heel pressure injuries for
patients in the acute care setting? SEARCH STRATEGY: A search of the literature was performed by a
trained university librarian that resulted in 56 articles that examined pressure injury, prevention, and
prophylactic dressings. A systematic approach was used to review titles, abstracts, and text, yielding 13
studies that met inclusion criteria. Strength of the evidence was rated based on the methodology from
Essential Evidence Plus: Levels of Evidence and Oxford Center for Evidence-Based Medicine. FINDINGS:
Thirteen studies were identified that met inclusion criteria; 1 was a randomized controlled trial, 2 were
systematic reviews, 3 quasi-experimental cohort studies, 1 quality improvement study, 1 case series, 1
scoping review, 1 consensus panel, and 3 bench studies. All of the studies identified suggest that the use
of prophylactic foam dressings reduces the development of pressure injuries on the heel when used in
conjunction with a pressure injury prevention program. The strength of the evidence for the identified
studies was level 1 (4 level A, 4 level B, and 5 level C). CONCLUSION/RECOMMENDATION: The use of
prophylactic multilayer foam dressings applied to the heels, in conjunction with an evidence-based
pressure injury prevention program, is recommended for prevention of pressure injuries on the heel
(SORT level 1).
Type of Article: Journal article
PMID: 29300293
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/29300293
32. Development and evaluation of a new methodology for the fast generation of patient-specific
Finite Element models of the buttock for sitting-acquired deep tissue injury prevention
Macron, A., Pillet, H., Doridam, J., Verney, A. and Rohan, P. Y., J Biomech 79 173-180. (2018)
The occurrence and management of Pressure Ulcers remain a major issue for patients with reduced
mobility and neurosensory loss despite significant improvement in the prevention methods. These
injuries are caused by biological cascades leading from a given mechanical loading state in tissues to
irreversible tissue damage. Estimating the internal mechanical conditions within loaded soft tissues has
the potential of improving the management and prevention of PU. Several Finite Element models of the
buttock have therefore been proposed based on either MRI or CT-Scan data. However, because of the
limited availability of MRI or CT-Scan systems and of the long segmentation time, all studies in the
literature include the data of only one individual. Yet the inter-individual variability can’t be overlooked
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when dealing with patient specific estimation of internal tissue loading. As an alternative, this
contribution focuses on the combined use of low-dose biplanar X-ray images, B-mode ultrasound images
and optical scanner acquisitions in a non-weight-bearing sitting posture for the fast generation of
patient-specific FE models of the buttock. Model calibration was performed based on Ischial Tuberosity
sagging. Model evaluation was performed by comparing the simulated contact pressure with
experimental observations on a population of 6 healthy subjects. Analysis of the models confirmed the
high inter-individual variability of soft tissue response (maximum Green Lagrange shear strains of 213+/-
101% in the muscle). This methodology opens the way for investigating inter-individual factors
influencing the soft tissue response during sitting and for providing tools to assess PU risk.
Type of Article: Evaluation Study
PMID: 30201252
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/30201252
33. Pressure ulcer prevention: heels at a glance
Lumbers, M., Br J Nurs 27 (6): S6-S8. (2018)
The article discusses prevention and management strategies for the treatment of pressure ulcers that
occur in the heel of the foot. It provides information on offloading methods of preventing pressure on
the Achilles tendon, pressure redistribution surfaces, and prophylactic treatments such as dressings,
creams, and barriers.
PMID: 29561680
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/29561680
34. Prevention of heel pressure ulcers among adult patients in orthopaedic wards: an evidence-based
implementation project
Koh, S. Y., Yeo, H. L. and Goh, M. L., Int J Orthop Trauma Nurs 31 40-47. (2018)
BACKGROUND: Immobility and prolonged bed rest often lead to heel pressure ulcers in patients. A point
prevalence audit undertaken in the orthopaedic wards of a Singapore tertiary hospital reported that 6
out of 30 patients who were audited had mild to blanching redness on their heels. AIMS: The evidencebased project sought to achieve 80% compliance from nurses to perform heel off-loading practice and a
50% reduction in the occurrence of heel pressure ulcers. METHODS: The project, lasting two years, was
undertaken in two orthopaedic wards and utilized a pre- and post-implementation audit strategy using
the Joanna Briggs Institute on-line ‘Practical Application of Clinical Evidence System’ and ‘Getting
Research into Practice’ programs. Implementation occurred in four phases and involved a sample
consisting of 30 adult patients. RESULTS: Nurses’ compliance with performing heel off-loading
techniques increased. The post-implementation audit showed 93.3% compliance of nurses undertaking
heel off-loading techniques in the subsequent four follow-up audits. Meanwhile, the compliance with
documentation increased from 63.3% to 86.7%. The project resulted in more than 50% reduction in
stage one heel pressure ulcers. CONCLUSION: The implementation of heel off-loading techniques
significantly reduced the incidences of heel pressure ulcers in orthopaedic wards.
PMID: 30316760
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Link to article: https://www.ncbi.nlm.nih.gov/pubmed/30316760
35. The effect of Aloe Vera gel on prevention of pressure ulcers in patients hospitalized in the
orthopedic wards: a randomized triple-blind clinical trial
Hekmatpou, D., Mehrabi, F., Rahzani, K. and Aminiyan, A., BMC Complement Altern Med 18 (1): 264.
(2018)
BACKGROUND: One of the most common orthopedic problems is the incidence of pressure ulcer
followed by immobility. This study aimed to investigate the effect of Aloe Vera gel on the prevention of
pressure ulcer in patients hospitalized in the orthopedic ward. METHOD: This study is a randomized,
triple-blind clinical trial which was done on 80 purposefully selected patients in orthopedic ward in Arak
town, Iran, 2016. Patients were randomly assigned into two intervention and control groups based on
blocking sampling method. In each group the routine daily cares to prevent bed sores were performed
by nurses. In the intervention group in addition to routine nursing care to prevent bed sores, twice a day
(hours of 9 and 21) pure Aloe Vera gel on the areas of hip, sacrum and heel were rubbed, but in the
control group placebo (gel of water and starch) were used. Then sacral, hip and heel of both groups on
days 3, 7 and 10 for of signs of pressure ulcers was evaluated. RESULTS: The mean age of patients in the
control group was (42.34 +/- 12.19) and in the intervention group Was (41.71 +/- 11.50) years,
respectively. In the intervention group 1 patient afflicted with sore of hip and two people with sacral
pressure ulcer. In the control group 3 patients affiliated with sore of hip, 8 people with sacral pressure
ulcer, and 1 person had pressure sore of heel. Analysis of the data showed that both groups had
statistically significant differences in the incidence of pressure ulcers (P = 0.047). This means that Aloe
Vera gel could prevent the occurrence of pressure ulcers in the intervention group. CONCLUSION: Due
to the effect of Aloe Vera gel to prevent a rise in temperature, non-blanchable redness, swelling and
pain of the skin of regions under study in hospitalized patients in the orthopedic ward, applying of it
toward the prevention of pressure ulcers in patients at risk of pressure ulcer development is
recommended. TRIAL REGISTRATION: This study was registered in Iranian Registry of Clinical. Trials in
07/09/2016 with the IRCT ID: IRCT2016051027825N1 .
Type of Article: Randomized Controlled Trial
PMID: 30268162
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/30268162
36. Recent Advances and Future Opportunities to Address Challenges in Offloading Diabetic Feet: A
Mini-Review
Crews, R. T., King, A. L., Yalla, S. V. and Rosenblatt, N. J., Gerontology 64 (4): 309-317. (2018)
Diabetic foot ulcers (DFU) are a substantial dilemma for geriatric individuals with diabetes. The
breakdown in tissue associated with DFU is typically a result of repetitive cycles of physical stress placed
on the feet during weight-bearing activity. Accordingly, a key tenet in healing as well as preventing DFU
is the use of offloading footwear to redistribute physical stress away from high stress locations such as
bony prominences. Over the last several years there has been a substantial amount of effort directed at
better understanding and implementing the practice of offloading. A review of this work as well as
relevant technological advances is presented in this paper. Specifically, we will discuss the following
topics in association with offloading diabetic feet: achieving optimal offloading, dosing activity/physical
Search report courtesy of Library & Knowledge Services library@baptisthealth.net
stress, thermal monitoring to detect preulcerative tissue damage, adherence with offloading devices,
and optimizing the user experience. In addition to presenting progress to date, potential directions for
further advancement are discussed.
Type of Article: Review
PMID: 29402807
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/29402807
37. Decreasing an Offloading Device’s Size and Offsetting Its Imposed Limb-Length Discrepancy Lead to
Improved Comfort and Gait
Crews, R. T. and Candela, J., Diabetes Care 41 (7): 1400-1405. (2018)
OBJECTIVE: Patient adherence is a challenge in offloading diabetic foot ulcers (DFUs) with removable
cast walkers (RCWs). The size and weight of an RCW, changes to gait, and imposed limb-length
discrepancies may all discourage adherence. This study sought to determine whether RCW size and
provision of a contralateral limb lift affected users’ comfort and gait. RESEARCH DESIGN AND METHODS:
Twenty-five individuals at risk for DFUs completed several 20-m walking trials under five footwear
conditions: bilateral standardized shoes, a knee-high RCW with shoe with or without an external shoe
lift contralaterally, and an ankle-high RCW with shoe with or without an external shoe lift
contralaterally. Perceived comfort ratings were assessed through the use of visual analog scales. Spatial
and temporal parameters of gait were captured by an instrumented walkway, and plantar pressure was
measured and recorded using pedobarographic insoles. RESULTS: The bilateral shoes condition was
reported to be most comfortable; both RCW conditions without the lift were significantly less
comfortable (P < 0.01). In contrast to the ankle-high RCW, the knee-high RCW resulted in significantly
slower walking (5.6%; P < 0.01) but greater offloading in multiple forefoot regions of the offloaded foot
(6.8-8.1%; P < 0.01). Use of the contralateral shoe lift resulted in significantly less variability in walking
velocity (52.8%; P < 0.01) and reduced stance time for the offloaded foot (2.6%; P = 0.01), but it also
reduced offloading in multiple forefoot regions of the offloaded foot (3.7-6.0%; P < 0.01).
CONCLUSIONS: Improved comfort and gait were associated with the ankle-high RCW and contralateral
limb lift. Providing this combination to patients with active DFUs may increase offloading adherence and
subsequently improve healing.
Type of Article: Study
PMID: 29666111
Link to article: https://www.ncbi.nlm.nih.gov/pubmed/29666111
Search report courtesy of Library & Knowledge Services library@baptisthealth.net
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