Poster session 28: Late abstracts - International Symposium on the

Poster session 28: Late abstracts
P28.01
Limb salvage with Boyd amputation in challenging diabetic patients
Hakan Arslan, İstanbul University Cerrahpaşa Medical School, İstanbul, Turkey
Muzaffer Altındaş, İstanbul University Cerrahpaşa Medical School, İstanbul, Turkey
Anıl Demiröz, Mardin State Hospital, Mardin, Turkey
Uğur Bingöl, Yeditepe University, Medical School, İstanbul, Turkey
Talectomy and calcaneotibial arthrodesis was described by Boyd in 1939. Although it’s been
a long time since, this procedure was not used frequently and it did not gain popularity
among the other partial foot amputation operations. Some authors have even reported Boyd
amputation procedure as “not appropriate for diabetic patients”.
We state that; with an acurate analysis of the diabetic foot lesions and a good understanding
of the developments in wound treatment, Boyd procedure is a feasible method for diabetic
patients in order to salvage the limb. In an interval of 10 years, for a wide variety of patients
including acute progressive diabetic foot infection cases, advanced stage Charcot artropathy
patients, chronic dialysis patients, immunosuppressed patients under steroid treatment and
critical ischemic cases, we used this method and it became a frequently used procedure in
our clinic.
Between 2004-2015 we performed 41 Boyd amputations for diabetic foot. Mean age was 59
6, mean duration of diabetes was 17 years. 26 of the patients were admitted with acute
progressive diabetic foot wounds and 10 of them had gas gangrene. The other 15 patients
had chronic wounds resistant to conservative treatment. 12 of the cases had advanced
stage Charcot, with bone and joint involvement. 3 patients had Buerger’s disease in addition
to diabetes. 3 patients were under steroid treatment for a long time; 2 of them for chronic
rheumatoid arthritis and 1 patient for pemphigus vulgaris. Partial calcanectomy was required
during the wound preparation period in 4 of the cases because of calcaneal involvement.
Calcaneotibial arthrodesis and a complete soft tissue recovery were achieved in 40 cases. In
one case, infection and necrosis could not be taken under control following Boyd operation
and a transtibial amputation was performed.
Boyd operation is the most difficult method among the foot operations considering the need
for wound care management, indication selection, planning and surgical technique. It
requires a high level of training in plastic and reconstructive surgery as well as knowledge
and experience in orthopedics and diabetic foot wounds. Boyd operations can be performed
using the knowledge, experience, skills and patience learned during the other foot
operations.
www.diabeticfoot.nl
Page 1 of 11
P28.02
Epidemiology of diabetic foot infections and predictive factors for amputation
Nese Saltoglu, Istanbul University Cerrahpasa Medical Faculty, Istanbul, Turkey
Mucahit Yemisen, Istanbul University Cerrahpasa Medical Faculty, Istanbul, Turkey
Serkan Surme, Istanbul University Cerrahpasa Medical Faculty, Istanbul, Turkey
Mucahit Ozyazar, Istanbul University Cerrahpasa Medical Faculty, Istanbul, Turkey
Hasan Tuzun, Istanbul University Cerrahpasa Medical Faculty, Istanbul, Turkey
Yagmur Aydin, Istanbul University Cerrahpasa Medical Faculty, Istanbul, Turkey
Aim:To determine epidemiology and clinically relevant risk factors for, amputation in,
patients with diabetic foot infection (DFI).
Methods: In this single center prospective study, between January 2013 and December
2014, we followed 83 hospitalized patients with DFI and we assessed at baseline for
demographic information, clinical, laboratory and microbiological findings. Infection was
diagnosed, according to the validated system for infection severity, defined by International
Working Group of (IWGDF). We conducted univariate analysis of data at baseline, including
microbiological and medical characteristics of DFI. Chi-square test was used for comparison
of the categorical variables.
Results: Of the 83 patients, 56 were male /(%67 5), and the mean age of the patients was
63.5 years. IWGDF, infection classification showed :25 cases were grade II, 41 cases were
grade III and 17 cases were grade IV.Of all patients, 58 (69 9 %) had osteomyelitis, 25 had
complicated SSTI. The pathogens were isolated from 65 patients (78 3%), and in 39 patients
(47%), polimicrobial infection was determined. Of the 84 microorganisms isolated; 33 (39%)
Gram-positive cocci and 51(61%) were Gram-negative rods (GNR). Of this pathogens; 7 (8
4%) were MDR, 8 (9 6%) were ESBL producing GNR, 14 (16 9%) were ınducible betalactamase, producing GNR, and 2(2 4%) were methicillin resistant Stapylococcus aureus
(MRSA) and 10(12%) were methicillin resistant coagulase negative Staphylococcus
(MRCNS). The data is shown on Table 1. Amputations were performed in 49/83 (59%)
patients, 11(22 4%) of these major amputations. At the end of the first line treatment 58 (69
9%) patients improved, 22 (%26 5) patients had re-infection and 2 (2 4%) patients died. On
univariate analysis, statistically significant factors for amputation were found as severity of
infection (p<0.0001), osteomyelitis (p<0.0001), CRP>20 fold (p=0 047), ESR>70mm/hr (p=0
007), leukocyte>10.000/mm3 (p=0 018, polymicrobial infection (p=0 007) and MR-CNS
isolation (p=0 029). Osteomyelitis was found to be the only factor affecting amputation on
multivariate analysis (p<0.0001), (OR: 115).
Conclusion: The presence of osteomyelitis was an independent predictor of amputation.
Baseline levels of ESR, CRP, leucocyte and polymicrobial infection appeared to be helpful
for clinicians in predicting amputation.
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Page 2 of 11
Total: 83 patient
Clinical improvement
Recurrent infection
Leukocyte count
>10.000/mm3
ESR >70mm/h
CRP>20-fold
CRP (0-5 normal)
Rate of amputation
Polymicrobial
infection
Multidrug resistant
microorganism
MR-CNS (+)
MRSA (+)
IBL producing Gram
negative rod (GNR)
ESBL producing,
GNR
(E.coli: 4, Klebsiella
spp:4)
Osteomyelitis:,
n: 58
N, %
35 (61,4)
20 (35)
40 (71,4)
c-SSTI
n: 25
N, %
23 (92)
2, (8)
10 (41,7)
P value
38 (67,9)
23 (41,1)
9 (37,5)
6 (24)
0.011
0,13
48 (82,8)
1 (4)
<0,0001
33(84,6%)
6(15,4%)
<0,0001
5 (8,9)
2 (8)
0,89
9 (16,1)
1 (1,8)
12 (21,4)
1 (4)
1(4)
2 (8)
0,127
0,55
0,14
6 (10,9)
2 (8)
0,68
0.019
0,012
Table 1. Comparison of clinic, laboratory and microbiological properties of diabetic foot
patients with Osteomyelitis and complicated-Skin-Soft Tissue Infection (c-SSTI)
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Page 3 of 11
P28.03
The impact of a new podiatry service on length of stay of in-patients with diabetic foot
complications in a general hospital in Ireland
Molly Smith, Health Service Executive, Wexford, Ireland
Obada Yousif, Health Service Executive, Wexford, Ireland
Aim: To determine the impact of a new podiatry service on LOS of in-patients with diabetic
foot complications in a general hospital in Ireland.
Methods: Study data was taken from the Hospital In-Patient Enquiry Scheme (HIPE). HIPE
is a system that collects information on hospital in-patient and discharge activity in Ireland.
Data is taken from medical records and coded by trained clinical coders before entering into
the HIPE system. ,
The HIPE system has two diagnoses codes for patients admitted with diabetic foot
complications. They are “Diabetic Foot” and “Diabetes with Foot Ulcer”. LOS of these
inpatients was calculated for July to November 2014, the first five months when the hospital
had a podiatrist and also for July to November 2013 when the hospital had no podiatrist. ,
Results: The new podiatry service had a positive impact on LOS of in-patients with diabetic
foot complications. The LOS of these in-patients from July to November 2014 was 181 days
and from July to November 2013 was 357 days. This shows a reduction in inpatient LOS of
176 (49.2%) days for the five month period where the hospital had a podiatrist compared to
when the hospital did not have a podiatrist. December 2014 H.I.P.E data had not been
released at the time of the study. ,
Discussion and Conclusion: It is recognized internationally that the cost of treatment for a
hospital in-patient with a diabetic foot complication is substantially more than that of the
average hospital in-patient. There is a lack of research on the cost of treatment for a hospital
in-patient with a diabetic foot complication in Ireland however recent data puts the average
nightly cost of an in-patient in a public hospital in Ireland at over €900 per night. This study
found a reduction of 176 days spent in hospital for in-patients with diabetic foot
complications over a five month period which represents significant cost savings.
There are a large number of studies on the diabetic foot which focus on reductions in
amputation and healing rates as a positive service outcome. This was a small study in a
single study centre. Further larger studies in this area are welcome and could potentially
support increased podiatry service provision in overstretched healthcare economies.
www.diabeticfoot.nl
Page 4 of 11
P28.04
Do diabetic foot ulcers develop at peak shear locations?, A call to revisit ulceration
pathomechanics
Linda Adams, University of North Texas Health Science Center, Fort Worth, TX, United
States
Hiral Master, University of North Texas Health Science Center, Forth Worth, TX, United
States
Alan Garrett, University of North Texas Health Science Center, Fort Worth, TX, United
States
Lawrence Lavery, University of Texas Southwestern Medical Center, Dallas, TX, United
States
Metin Yavuz, UNT Health Science Center, Fort Worth, TX, United States
Aim: Rationale for diabetic foot ulcer (DFU) prevention is centered on pressure relief.
However, studies have revealed limited results from the use of protective footware [1].
Moreover, only 38% of DFU occur at the location of peak pressure (PP) [2]. The purpose of
this study was to investigate a site-wise association between healed ulcers and peak plantar
shear (PS) loading using a custom-built device [3].
Methods: Four nueropathic diabetic subjects (3 F, 1 M) with 5 recently healed plantar ulcers
were recruited after signing an IRB-approved consent form. Subjects walked on a custombuilt stress plate that quantified tri-axial plantar stresses. Peak data was obtained from the
average of 3 trials. The data was then compared to ulcer site locations for descriptive
analysis.
Results: In 2 subjects, locations of PS and PP didn’t overlap, and the PS site coincided with
an ulcer (Figure 1). A third DFU coincided with the location of PP. In the remaining 2
subjects, PS and PP overlapped and coincided with the ulcer site.
Conclusions: Results validate previous studies indicating that PS and PP don’t always
coincide anatomically [4]. They also indicate a relationship between PS and DFU location.
Results obtained in this ongoing study indicate a need for researchers to revisit ulceration
pathology.
Acknowledgements:
This study was possible due to research funding from the NIH (R15DK082962).
References:
1. Bus et al. (2008). Diabetes Metab Res Rev, 24(S1), 162-180
2. Veves et al. (1992). Diabetologia, 35(7), 660-3
3. Yavuz et al. (2007). J Bimech, 40(13), 3045-9
4. Yavuz et al. (2007). Diabetes Care, 30, 2643-2645.
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Page 5 of 11
Figure 1, A) Peak plantar shear (24 kPa) under the right hallux, the same position where the
ulcer developed, B) Peak plantar pressure (167 kPa) under the central midfoot, and C) Foot
placement on stress plate.
www.diabeticfoot.nl
Page 6 of 11
P28.05
Female Patients with diabetic foot are at high risk of cognitive disorders in a
consecutive inpatient population
Anna Katharina Trocha, Elisabeth Krankenhaus, Essen, Germany
Angela Suermann, Elisabeth-Krankenhaus, Essen, Germany
Andrea Engels, Elisabeth-Krankenhaus, Essen, Germany
Angelika Meier, Elisabeth-Krankenhaus, Essen, Germany
Hans Georg Nehen, Elisabeth-Krankenhaus, Essen, Germany
Aim: Aim of our study was to show the frequency of cognitive disorders among elderly
inpatients of a specialized diabetic foot care centre and to find risk factors.
Methods: All patients older than 60 years who were admitted to a specialized diabetic foot
clinic between January and August 2014 are offered a screening for dementia by using the
clockdrawing test. According to medical records patients characteristics were collected and
data were analysed with SPSS, MS Excel and Fisher Exact Test,
Results: Out of 127 Patients with DF 75 (59%) agreed and were screened (drop out for
know dementia 11.8%, visual impairment 2.4%, language barrier 4.7%, medical reasons
6.3%, organisational 13.4%, refusal 2.4%)
Patients characteristics were: mean age 74 4 years (y), 73 3% male, mean HbA1c 7.68%,
mean diabetes duration 19.8 y, arterial hypertension 78%, serum creatinin 1.4 mg/dl,
Glomerular filtration rate 54.7 ml/min, cardiovascular disease 72 %, Ex smoker 53%, Smoker
12%.
55% of all screened patients showed a pathological clock drawing test. There was a
significant correlation between age above 70 and pathological clock test (p=0.0026). 25 out
of 55 male patients (45.5%) and 15 out of 20 female patients, (75%) had a pathological
clock. This gender difference was significant, (p=0.0042).
Mean age of female patients was 76.7y (78.53 y with and 71.0 y without pathological clock
test) compared to male patients mean age of 73.6 y (76 4 y vs. 71.7 y)
There was no correlation of clock test result and diabetes duration, HbA1c, serum creatinin,
cardiovascular comorbidities or smoking habits.
Conclusions: More than half of the inpatients of a Diabetic foot clinic older than 60 years
who were declared „normal“ in orientation and behaviour were suspicious of a cognitive
disorder shown by a pathological clock test. The high number (75%) of female patients with
diabetic foot and pathological clock test spotlights an unknown group of high risk for
cognitive disorders. If gender connected differences in the female DF population such as
higher age or higher percentage of atherosclerosis have contributed to this difference has to
be elucidated in further studies
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Page 7 of 11
P28.06
Diabetic foot infections: Systematic review of microbial prevalence in our hospital
Federico Grasa González, Sistema Andaluz de Salud, Algeciras, Spain
Background: Foot infections are a common reason for hospitalization and complications in
patients with diabetes mellitus. The aim of this study was to determine the prevalence of
microorganisms found on culture in complicated Diabetic Foot infections in hospitalized
patients (PEDIS 3-4 of IDSA)
Methods: Between January 2012 and December 2014 in our department, 52 samples in 79
diabetic patients with moderate/severe infection were collected for microbiological study
previous to undergo a surgery
Results: At least one microorganism was isolated in 75% of samples. The most frequently
isolated germ group was gram-positive bacteria (75%), most frequently Staphylococcus
aureus (40%), followed by Pseudomonas aeruginosa (15%), Enterococcus spp. (15%), and
Escherichia coli (5%). Among the multiresistant microorganisms, MRSA were the most
common (20%), followed by E.coli resistant to amoxicillin/clavulanic acid and ciprofloxacin.
Image
Discussion: On the superficial and mild infections predominate gram-positive cocci (S.
aureus and Beta-hemolytic streptococci), whereas the deeper and often severe
polymicrobial with gram-positive cocci, gram-negative bacilli (Enterobacteriaceae and P.
aeruginosa) and anaerobic (Peptostreptococcus spp. and Bacteroides spp.). Anaerobic are,
especially in the presence of ischemia or necrosis and generally part of mixed infections. In
conclusion, on the basis of the results obtained in this study, it is considered that the regular
consumption of crops wounds and study of the specific sensitivities for different
microorganisms in each healthcare environment is of great importance in the choice of
antibiotic treatment. This is important especially when the clinical evolution is not ideal or
when osteomyelitis is demonstrated. The consensus proposal that made the Spanish
Societies General Surgery, Vascular Surgery, Chemotherapy and Internal Medicine 2011,
seems very appropriate for the empirical treatment approach based on the severity of
infection: use the oral amoxicillin/clavulanic acid for minor infection; intravenous ertapenem
for moderate or severe infections; and the other carbapenems or piperacillin-tazobactam,
associated with linezolid, for very serious infections, which is convenient cover P. aeruginosa
and MRSA.
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Page 8 of 11
P28.07
The effectiveness of felt padding in offloading diabetes-related foot ulcers, initially
and after a period of wear
Anita Raspovic, La Trobe University, Bundoora, Australia
Wan Mun Wong, La Trobe University, Bundoora, Australia
Kate Waller, The Northern Hospital, Epping, Australia
Aim: A recent survey conducted in Australia found that felt padding is commonly selected by
clinicians to offload diabetes related plantar neuropathic foot ulceration, although limited
quality data exists to support its use [1 2]. The aim of this study was to quantify how much
pressure is offloaded from sites of neuropathic ulceration, when felt padding is first applied
and after 7 days of wear.
Methods: This study used a within-subjects, repeated measures design. Fourteen
participants with 15 ulcers were recruited from a high risk foot service in Melbourne,
Australia. Peak plantar pressures were evaluated over sites of non-infected, non-ischaemic
plantar neuropathic ulceration over two sessions under the following conditions: no felt
padding, newly applied felt padding and the same felt padding after one week of wear.
Contact area and contact time under the whole foot were also analysed.
Results: Mean peak pressure values in kPa (±SD) for no felt padding, newly applied felt
padding and worn felt padding respectively, were; 357(±144), 199 (±77) and 248 (±130).
Statistically significant differences in peak pressure were found when no felt padding was
compared to both newly applied felt padding (p = 0.001), a decrease of 44% with felt, and
worn felt padding (p = 0.006), a decrease of 31% with felt. New felt decreased plantar
pressure 20% more than worn felt (p = 0.023). Results for contact area under the whole foot
followed the same trend as peak pressure, with statistically significant differences between
no padding and both newly applied felt padding (p = 0.001), or a 16% increase with felt, and
worn felt padding (p = 0.002), or an 11% increase with felt. New felt increased contact area
5% more than worn felt (p = 0.005).There were no statistically significant differences in
contact time between the 3 conditions tested, indicating that walking speed was constant.
Conclusions: These findings show that both new and worn felt padding offer significant
pressure offloading over sites of plantar neuropathic ulceration, although this diminishes
over a one week period of wear. The increase in contact area under the entire foot is one
possible mechanism by which felt achieves this result. Given these results, further studies
are required to evaluate the effectiveness of felt padding directly, on ulcer healing.
References
Raspovic A. J Foot Ankle Res 2014, 7:35.
Lewis J. Cochrane Database Sys Rev 2013, 1:CD14002302.
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P28.08
Choosing a set of instruments to identify the patient at risk of foot ulceration. Results
from the Rotterdam Diabetic Foot Study
Willem Rinkel, Erasmus MC, Rotterdam, Netherlands
Introduction: We analysed baseline measurements of diabetics from the Rotterdam
Diabetic Foot Study, a cohort to study the deterioration of sensation of the feet, over time. In
literature, PNP is formulated as the inability to sense the 10 g monofilament on 3-15 sites of
the feet. We believe that this does not cover the whole spectrum of PNP and gives an
underestimation of the prevalence. The aim of this study is to assess which set of commonly
used screening instruments provide the best estimate in predicting the existence of diabetic
polyneuropathy (PNP), the most important risk factor for developing foot ulceration.
Methods: We assessed the sensation of 652 feet. The Rydel-Seiffer tuning fork detects the
vibration threshold on two sites of both feet (dorsal distal hallux and medial malleolus) and
cutaneous threshold (one point static discrimination (S1PD) on five locations of the foot with
monofilaments ranging from 0 008 – 300 grams. The test sites (pulp of first and 5th toe,
medial heel (above callus), first web and lateral foot) were chosen corresponding to the
nerve distribution of the foot. Subjective neuropathy complaints were assessed via the
Michigan Neuropathy Screening Instrument (MNSI).
Results: Screening on 5 sites per foot (S1PD (≥ 10 g)), resulted in a prevalence of PNP of 3
8% in our population. The accuracy (area under the curve (AUC)) of the MNSI to detect
polyneuropathy was poor (64 1%). When we choose to detect pathological cutaneous- and
age corrected vibration thresholds with tuning fork and monofilaments (≥ 10 g, pulp of hallux
and 5th toe), the prevalence of neuropathy was 36 4%. 20% of patients scoring PNP with the
MNSI, did not have elevated cutaneous thresholds of the hallux on both feet. Therefore, we
state that our diabetics are having PNP when there is an inability to sense the 10 g
monofilament on the pulp of the first and 5th toe, together with an abnormal vibration
threshold of the foot. When only the right foot was screened for PNP using the tuning fork
and ≥ 10 g monofilaments on the pulp of hallux and 5th toe, the accuracy (AUC) to predict
the same condition on the left foot was excellent (92 2%).
Conclusion: To point out the diabetic having symmetrical polyneuropathy, only the right foot
needs to be examined using the Rydel-Seiffer tuning fork and monofilaments. More test sites
are more time consuming and not helpful at pointing out the patient having PNP and
therefore being at risk for foot ulceration.
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Page 10 of 11
P28.09
Challenges of designing a placebo-controlled trial for treating mild diabetic foot ulcer
infections: The pexiganan cream “OneStep” trial
Benjamin Lipsky, University of Oxford, Oxford, United Kingdom
Michael Silverman, Dipexium Pharmaceuticals, Chicago, United States
Warren Joseph, Roxborough Memorial Hospital, Philadelphia, United States
Aim: Pexiganan, a 22 amino acid host defense protein1, demonstrated efficacy in 2 clinical
trials, of a 0.8% cream* comparable to oral ofloxacin in treating mildly infected diabetic foot
ulcers (DFU)2. Subsequent US regulatory requirement for a placebo-controlled trial posed
several major clinical research design challenges. We present how we addressed the
challenges, and the design of the resulting FDA-approved, ongoing protocol.
Methods: We designed a randomized, double-blind, placebo-controlled clinical trial through
collaborative & highly iterative efforts of experts in DFU infections, clinical research,
biostatistics, & regulatory affairs. We directed substantial attention to: protecting subject
safety in a study including placebo treatment of an infection; selecting & characterizing an
appropriate patient population; optimizing & standardizing required wound care techniques;
rigorously defining required clinical measurements & endpoints; and, carefully selecting,
intensively training, & maintaining communication with committed, experienced clinical
investigators.
Results: The primary trial efficacy objective is to establish clinical superiority of topical
pexiganan, versus placebo, cream. Subjects with a DFU ≥1 cm2 with mild infection by
standard criteria3 amenable to outpatient treatment are randomized 1:1 to active or placebo
cream. They then: receive standardized wound care; undergo wound photographs & digital
measurements; apply their assigned cream twice daily for 14 days; and, are assessed for
safety & efficacy during treatment & 14 days later. We recruited >50 investigative sites &
trained clinicians in intensive, practical sessions. For quality assurance the trial management
team regularly reviews wound entry photographs & measurements. An independent safety
monitoring committee reviews cases of progressive infection or serious adverse events.
Conclusions: We report the design and implementation of a pioneering placebo-controlled
trial of a topical antibiotic in mild DFU infections (NCT01590758/01594762). Critical success
factors include a multidisciplinary approach to design; rigorous standardization of wound
care and trial procedures; intensive safety and quality monitoring oversight; and, detailed
and ongoing investigator feedback and training.
*Locilex®
Funded by Dipexium Pharmaceuticals
www.diabeticfoot.nl
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