Research Article Amputations of Lower Limb in Subjects With Diabetes Mellitus: Reasons and 30-Day Mortality
Research Article Amputations of Lower Limb in Subjects With Diabetes Mellitus: Reasons and 30-Day Mortality
Research Article Amputations of Lower Limb in Subjects With Diabetes Mellitus: Reasons and 30-Day Mortality
Research Article
Amputations of Lower Limb in Subjects with Diabetes Mellitus:
Reasons and 30-Day Mortality
Received 13 April 2021; Revised 7 June 2021; Accepted 15 July 2021; Published 26 July 2021
Copyright © 2021 Magdalena Walicka et al. This is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is
properly cited.
Background. Diabetic foot is one of the leading causes of patient disability worldwide. Lower-extremity amputations (LEAs)
resulting from this disease massively decrease quality of life, the function of the patient, and incur significant healthcare costs.
The aim of this study was to assess trends in the number of amputations, the diagnosis at discharge, and diagnosis-related
mortality after LEA procedures in a nationwide population. Methods. Datasets of the National Heath Fund containing
information about all services within the public healthcare system in Poland, spanning the years 2010-2019, were analyzed. The
source of data regarding mortality was the database of the Polish Ministry of Digital Affairs. Results. Between 2010 and 2019, the
annual number of amputations in patients with diabetes increased significantly from 5,049 to 7,759 (p for trend < 0:000001).
However, the number of amputations in patients with diabetes calculated as a number per 100,000 diabetics decreased significantly
(p for trend < 0:0005) during this period. Amputations in patients with diabetes accounted for a majority of all amputations; the
mean percentage of amputations in patients with diabetes was 68.6% of all amputations (from 61.1% in 2010 to 71.4% in 2019, p
for trend < 0:0000001). The most common disease diagnosed at discharge after LEA in diabetic patients was diabetes itself.
Vascular pathologies, such as soft-tissue/bone/joint infections and ulcerations, were the next most common. The 30-day mortality
rate after LEA was rather high in patients with, as well as without, diabetes (depending on the cause for amputation 3.5-34% and
2.2-28.99%, respectively). Conclusions. The number of LEA in patients with diabetes in Poland increased substantially between 2010
and 2019 along with an increasing number of diabetics. Vascular pathologies, infections, and ulcerations were the most common
causes of LEA. The 30-day mortality rate after amputation was rather high and varied depending on the diagnoses at discharge.
e.g., in a study conducted in Wroclaw (Poland), it was found information can be merged. The source of Poland’s popula-
that 7.28% of diabetic patients have peripheral neuropathy; tion data is Statistics Poland.
35.37%, calluses; 24.2%, foot deformities; and 17.39%, fea-
tures of the pathology of arterial vessels [3]. 2.2. Definition of the Diabetic Population. A person was con-
Diabetic foot syndrome may result in lower-extremity sidered diabetic when he/she had at least one diabetic ICD-10
amputation. According to the Global Burden of Diseases, code (any code within the E10-E14 range) reported as the
Injuries, and Risk Factors Study (GBD), in 2016, about 131 main reason for the service within the public healthcare sys-
million people (1.8% of the global population) had tem. The registered diagnosis date was identified as the date
diabetes-related lower-extremity complications, including of the very first issuance of a relevant diabetic ICD code.
6.8 million amputations [4]. It should be noted that cases The diabetic population in a given year was defined as the
with diabetes account for 60-70% of all lower-extremity registered prevalence at the end of the year (December
amputations (LEA) [5, 6]. Diabetes-related lower-extremity 31st). Specifically, the population was composed of diabetic
complications are a large and growing contributor to the dis- patients who had been diagnosed up until the end of that year
ability burden worldwide [4]. Lower limb amputation con- and had not yet died.
currently leads to an increase in illness-related costs and a
2.3. Amputations and Diagnoses at Discharge. The proce-
huge change in the quality of life and function of the patient.
dures analyzed in this paper are amputations of the lower
After LEA, patients have a diminished quality of life com-
limb (either of feet, toes, parts of feet, or other below-knee
pared to the general population [7]. A review of studies from
amputations). All of the ICD-9 procedures used in the data-
India indicates that the prevalence of psychiatric disorders
base search are listed in Table 1. The diagnoses at discharge
among this group of patients can be in the range of 32% to
after the LEA procedure were categorized by ICD-10 codes,
84%, including depression rates of 10.4%–63% and posttrau-
which during the examined years (2010-2019) were reported
matic stress disorder of 3.3%–56.3% [8]. Another problem to
as the main diagnosis for the hospitalization during which
consider in this population is the incidence of phantom limb
the amputation procedure was performed. The specified
pain and residual stump pain.
categories were diabetes, vascular (atherosclerosis and gan-
Lower-extremity amputations are also related to signifi-
grene), sepsis, acute conditions, infections of soft tissues
cant early and long-term postoperative mortality. In a
(skin, subcutaneous tissue, or muscles), ulcerations, infec-
national study performed in New Zealand on individuals
tions of bones or joints, trauma (including burns and
diagnosed with diabetes, more than 11% of patients who
frostbites), neoplasms, or others. All ICD codes that were
underwent major amputation died within 30 days, whereas
included into a specific category are given in Table 1.
nearly 18% died within 90 days [9]. In another population-
Diabetic amputations were defined as amputations which
based cohort study conducted in Italy, including patients
were performed on diabetic patients, no earlier than 30 days
with diabetes undergoing a primary amputation, mortality
before the diabetes diagnosis. In other words, amputations
rates at 1 and 4 years were 33% and 65%, respectively, for
predating the diabetic diagnosis by up to 30 days were con-
major LEA and 18% and 45% for minor LEA [10].
sidered diabetic. This is because of the relatively common
The aim of this study was to assess trends in the number
situation where the diabetic foot diagnosis is the first mani-
of amputations, the reasons for them, and the diagnosis-
festation of a patient’s diabetes. On the contrary, nondiabetic
related mortality after LEA procedures in patients with
amputations were defined as amputations in patients never
diabetes compared to the nondiabetic population.
diagnosed with diabetes. In effect, these parameters excluded
patients, in whom diabetes was diagnosed more than 30 days
2. Methods after the amputation, from the analysis. The number of
patients excluded by these parameters totalled 2,710 during
2.1. Data Sources. The source of health-related data is the
the 10 years of being analyzed.
Polish National Health Fund. The analyzed datasets contain
information about all services within the public healthcare 2.4. Statistical Analysis. The absolute number of all amputa-
system in Poland, spanning the years 2010-2019. The data tions and the number of amputations per 100 thousand
contains an anonymized patient identifier, which allows the inhabitants was determined. In the population with diabetes,
analyses to be made at the individual level. Each service the number of amputations per 100 thousand diabetic
within the public healthcare system (for example, hospitali- patients was also determined. The percentage of diabetes
zations, which were assessed in this paper) has an assigned and nondiabetes amputations was calculated. The statistical
ICD-10 code, which is put into the system by the healthcare significance for trends was assessed using an extended
professional who treated the patient. Additionally, in the case Mantel-Haenszel chi-square test for linear trend [11].
of surgical hospitalizations, information about surgical pro-
cedures performed within the service (like hospitalization) 3. Results
is also introduced into the system. The source of data regard-
ing mortality is from the database of the Polish Ministry of 3.1. Number of Amputations. The number of amputations in
Digital Affairs. The information is based on death certificates patients with diabetes increased substantially between the
given out by registry offices; however, only the date of death, years 2010 and 2019 (from 5,049 to 7,759, p for trend <
but not the cause, is accessible in this database. Both data- 0:000001). In comparison, the number of amputations in
bases contain the same patient identifier, and therefore, the patients without diabetes was stable (3,214 in 2010 and
Journal of Diabetes Research 3
Table 1: ICD-10 codes used for defining the diagnosis at discharge Table 1: Continued.
categories and ICD-9 codes used for defining amputation procedure.
Category ICD-10 codes
Category ICD-10 codes 84.14; 84.15; 84.151; 84.31; 84.1; 84.10;
Vascular I70; R02 84.102; 84.103; 84.11; 84.111; 84.113;
M00; M01; M02; M03; M04; M05; 84.114; 84.119; 84.12; 84.121; 84.122;
M06; M07; M08; M09; M10; M11; 84.123; 84.124; 84.125; 84.129; 84.14;
Bone/joint infection M12; M13; M14; M15; M16; M17; 84.15; 84.151; 84.31; 84.1; 84.10;
M18; M19; M20; M21; M22; M23; 84.101; 84.102; 84.103; 84.11; 84.111;
M24; M25; M86; M87; M90 84.113; 84.114; 84.119; 84.12; 84.121;
84.122; 84.123; 84.124; 84.125; 84.129;
A18.4; A20.1; A22.0; A26.0; A28.1;
84.14; 84.15; 84.151; 84.31; 84.1; 84.10;
A30; A31.1; A32.0; A36.3; A43.1;
Soft tissue infection 84.10; 84.102; 84.103; 84.11; 84.111;
A44.1; A46; A48.0; A51.3; L00; L01;
84.113; 84.114; 84.119; 84.12; 84.121;
L02; L03; L04; L05; L06; L07; L08; M60
84.122; 84.123; 84.124; 84.125; 84.129;
Ulceration L88; L89; L97; I83.0; I83.2 84.14; 84.15; 84.151; 84.31; 84.1;
S70; S71; S72; S73; S74; S75; S76; S77; 84.101; 84.102; 84.103; 84.11; 84.111;
S78; S79; S80; S81; S82; S83; S84; S85; 84.113’; 4.114; 84.119; 84.12; 84.121;
Trauma (including burns S86; S87; S88; S89; S90; S91; S92; S93; 84.122; 84.123; 84.124; 84.125; 84.129;
and frostbites) S94; S95; S96; S97; 98; S99; T12; T13; 84.14; 84.15; 84.151; 4.31; 84.1; 84.101;
T24; T25; T31; T33.6; T33.7; T33.8; 84.10; 84.103; 84.11; 84.111; 84.113;
T34.6; T34.7; T34.8; T35.5 84.114; 84.119; 84.121; 84.122; 84.123;
C00; C01; C02; C03; C04; C05; C06; 84.124; 84.125; 84.129; 84.14; 84.15;
C07; C08; C09; C10; C11; C12; C13; 84.151; 84.31; 84.1; 84.10; 84.10;
C14; C15; C16; C17; C18; C19; C20; 84.102; 84.103; 84.11; 84.111; 84.113;
C21; C22; C23; C24; C25; C26; C27; 84.114; 84.119; 84.12; 84.121; 84.122;
C28; C29; C30; C31; C32; C33; C34; 84.123; 84.124; 84.125; 84.129; 84.14;
C35; C36; C37; C38; C39; C40; C41; 84.151; 84.31; 84.1; 84.10; 84.101;
C42; C43; C44; C45; C46; C47; C48; 84.102; 84.103; 84.11; 84.111; 84.113;
C49; C50; C51; C52; C53; C54; C55; 84.114; 84.119; 84.12; 84.121; 84.122;
C56; C57; C58; C59; C60; C61; C62; 84.123; 84.124; 84.125; 84.129; 84.14;
C63; C64; C65; C66; C67; C68; C69; 84.15; 84.151; 84.31; 84.1; 84.10;
Neoplasms C70; C71; C72; C73; C74; C75; C76; 84.101; 84.102; 84.103; 84.11; 84.111;
C77; C78; C79; C80; C81; C82; C83; 84.113; 84.114; 84.119; 84.12; 84.121;
C84; C85; C86; C87; C88; C89; C90; 84.122; 84.123; 84.124; 84.125; 84.129;
C91; C92; C93; C94; C95; C96; C97; 84.14; 84.15; 84.151; 84.31
D00; D01; D02; D03; D04; D05; D06;
D07; D08; D09; D10; D11; D12; D13;
D14; D15; D16; D17; D18; D19; D20; 3,109 in 2010, not significant). The trends for the number of
D21; D22; D23; D24; D25; D26; D27; amputations in diabetic and nondiabetic populations are
D28; D29; D30; D31; D32; D33; D34; shown in Figure 1(a). However, the number of amputations
D35; D36; D37; D38; D39; D40; D41; in patients with diabetes calculated as a number per
D42; D43; D44; D45; D46; D47; D48 100,000 diabetics decreased significantly during the 10-year
I21; I22; I46; I74; J20; J21: J22; J46: J80; period (259.73 in 2010 and 229.99 in 2019, p for trend <
J95: J96; J98; N17; A48.3; R57; T81.1; 0:0005) while the number of amputations in patients without
Acute
T79.4; O08.3; O75.1; T78.0; T78.2; diabetes calculated per 100,000 inhabitants was stable (8.34
T80.5; T88.2; T88.6 in 2010 and 8.1 in 2019, not significant). Those trends are
A02.1; A20.7; A22.7; A24.1; A26.7; illustrated in Figure 1(b).
Sepsis
A32.7; A42.7; R09.0; R09.2; R57.8; The mean percentage of amputations in patients with
A54.8; B00.7; B37.7; O75.3; T80.2; diabetes accounts for 68.6% of all amputations. This number
T81.4; T88.0; A40; A41; O85; B49 slowly increased year over year, beginning at 61.1% in the
Others year 2010 and reaching 71.4% in the year 2019 (p for trend
Diabetes E10; E11; E12; E13; E14 < 0:0000001).
84.1; 84.10; 84.10; 84.101; 84.102;
84.103; 84.11; 84.11; 84.111; 84.113; 3.2. Diagnoses at Discharge. In patients with diabetes, the
84.114; 84.119; 84.12; 84.12; 84.121; most common diagnosis upon discharge from the hospital
84.122; 84.123; 84.124; 84.125; 84.129; was “diabetes” (see Table 1 and Figure 2(a)). This diagnosis
Amputation
84.14; 84.15; 84.151; 84.31; 84.1; 84.10; does not give a precise reason for an amputation, and there-
84.10; 84.102; 84.103; 84.11; 84.111; fore, the proportion of the remaining diagnoses is altered. A
84.113; 84.114; 84.119; 84.12; 84.121; decision was made to show the percentage of the diagnoses
84.122; 84.123; 84.124; 84.125; 84.129; used in patients with diabetes which excluded the patients
mentioned above (Figure 2(b)).
4 Journal of Diabetes Research
9000
p for trend <0.000001
8000
7000
6000
5000
4000
NS
3000
2000
1000
0
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
DM
non-DM
(a)
300
p for trend<0.0005
250
200
150
100
50
NS
0
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
DM
non-DM
(b)
Figure 1: (a) Absolute number of amputations in patients with and without diabetes, and (b) number of amputations in patients with diabetes
per 100,000 diabetics, and in patients without diabetes per 100,000 inhabitants in the years 2010-2019.
Furthermore, the proportion of patients in whom an 3.3. Thirty-Day Mortality. The 30-day mortality was rather
amputation was performed for vascular reasons was similar high. The range varied depending on the reason for amputa-
in diabetics and nondiabetics. The same was true for both tion, from 3.46 to 34% in patients with diabetes, to 2.24 to
bone and joint infections. However, amputations in 28.99% in patients without diabetes (Table 2). In both
patients with diabetes were performed more frequently groups, mortality was highest in patients with sepsis or acute
because of soft-tissue infections and ulcerations. On the conditions. In other cases, the 30-day mortality did not
other hand, trauma and other causes for amputation were exceed 10%.
more common in patients without diabetes. Sepsis was a
rare cause for amputation in both groups, while neoplasms 4. Discussion
and various acute conditions (see Table 1) were in our
opinion, rather concomitant diseases or complications of In this paper, we have analyzed trends in lower limb amputa-
the procedure, than a reason for amputation (Figures 2(a) tions in patients with and without diabetes between the years
and 2(b)). 2010 and 2019 using a large national database. We found that
Journal of Diabetes Research 5
60 60
50 50
40 40
30 30
%
%
20 20
10 10
0 0
Vascular
Bones/joints
Soft tissue
Ulceration
Trauma
Neoplasm
Acute
Sepsis
Others
Diabetes
Vascular
Bones/joints
Soft tissue
Ulceration
Trauma
Neoplasm
Acute
Sepsis
Others
DM DM (after excluding the patients in whom the main
non-DM diagnosis at the discharge was diabetes)
non-DM
(a) (b)
Figure 2: (a) Percentage number of ICD-10 categories given as the main diagnosis at the discharge from the hospital after the amputation in
all study population and (b) in population after excluding the patients in whom the main diagnosis at the discharge was diabetes.
Table 2: Thirty-day mortality according to diagnosis at discharge categories in patients with and without diabetes.
the crude number of amputations in patients with diabetes in 2005-2009, both total diabetes-related and total
increased substantially (over 50%) and significantly, whereas nondiabetes-related amputation rates did not change signifi-
the number of amputations in patients without diabetes was cantly [15]. Similarly, in Austria, major lower-extremity
stable. We have noted also that if the number of amputations amputation rates in diabetic patients remained stable
in patients with diabetes was shown as a number per 100,000 between 2014 and 2017 [16].
diabetics, the amputation rate did not increase but rather It should be emphasized, that generally, the incidence of
decreased significantly during the 10 years of being analyzed. lower extremity amputation for all reasons in European
Thus, the reason for the increase in the absolute number of countries is variable [17]. Even in Poland, the geographic var-
diabetic amputations was the increasing number of patients iability of the numbers of major nontraumatic lower limb
with diabetes. amputations in diabetics was observed [18]. The number of
The rise in the total number of diabetic amputations was amputations in every country depends on many factors, i.e.,
observed also in Spain in 2002-2012 [12], but this large total funding for healthcare, availability of specialists’ clinics
national Spanish study does not present the data in relation and highly specialist treatment [18], dedicated wound ser-
to the number of diabetic patients (in this country, the diabe- vices and foot care services delivery [19], educational level,
tes incidence also rises [12, 13]). In the nationwide study per- and income of patient [20].
formed in Belgium between 2009 and 2013, just like in our In our study, “diabetes” was the most common diagnosis
study, the number of LEA significantly declined in individ- used upon discharge of diabetic patients undergoing LEA
uals with diabetes and remained stable in the population from the hospital. As mentioned above, it is obvious that this
without diabetes [14]. In turn, in the Irish study, performed diagnosis does not identify the precise reason for amputation
6 Journal of Diabetes Research
but rather is a diagnosis at discharge, and therefore, the complications and mortality compared with patients without
proportion of the remaining reasons for diagnoses is diabetes [26–28]. The overall 30-day mortality after major
altered. Therefore, we have decided to show, additionally LEA reported in other studies from various countries ranged
and separately, the percentage of the diagnoses used in from 1% to 13.5% [9, 16, 29] and was significantly correlated
patients with diabetes excluding the patients mentioned with age and age-adjusted comorbidity [16]. It has also been
above (Figure 2). shown that after LEA, patients with diabetes had an increased
Unfortunately, as in more than 50% of patients with dia- risk of death compared to nondiabetic patients [30]. How-
betes, the diagnosis at discharge was only “diabetes”; we were ever, in Ireland, a study performed in a single tertiary referral
not able to determine the real reasons for amputation in centre for vascular surgery showed no statistically significant
those subjects. We also cannot be sure that a diagnosis at association between mortality rate and comorbid diabetic
discharge was a reason for amputation. Those issues may mellitus in patients who underwent major lower limb
be regarded as limitations of this study. amputation [31].
It seems however that the main cause of LEA in diabetics Our study has several limitations. The first one is its ret-
is vascular pathology, mainly defined as a discharge diagnosis rospective character. Because of this, it is difficult to assess the
of atherosclerosis. The proportion of patients in whom real reason for each amputation, especially in the patients
amputation was performed for vascular reasons was similar diagnosed with “diabetes” at discharge, as well as in those
in diabetics and nondiabetics, when the discharge diagnosis for whom the diagnosis at discharge seems to reflect a com-
of diabetes was excluded. The same was true for bone or joint plication of, rather than the reason for, the procedure (e.g.,
infections. However, it seems that amputations in patients different acute conditions or sepsis). Other limitations
with diabetes were performed more frequently due to soft- include a lack of data about important risk factors for mortal-
tissue infections and ulcerations. This is of course not sur- ity, like diabetes control, concomitant diseases. However, the
prising, as a history of foot ulcers, osteomyelitis, or gangrene errors inherent to a retrospective study may be balanced out
is a well-known risk factor for amputation in diabetes [21]. In by the large size of the population.
the study performed in South Africa, infection and ulcers
were the leading causes of LEA in diabetic patients, while
ischemia was the most dominant cause in nondiabetic 5. Conclusions
patients [22]. In India, infection was also found to be the
leading cause of amputation [23]. However, it should be The number of lower-extremity amputations in diabetic
emphasized that peripheral arterial disease is reported in up patients in Poland increased substantially between the years
to 95% of people with diabetes receiving lower limb amputa- 2010 and 2019, whereas the number of amputations in
tions [24]. It was shown that amputation risk increases with patients without diabetes was stable. This increase is due to
increasing comorbidity burden, with peripheral vascular dis- the increasing number of patients with diabetes, seeing as
ease being one of the major independent risk factors [25]. the number of amputations/number of patients with diabetes
This seems to be consistent with our study, as atherosclerosis ratio remains stable. The 30-day mortality rate after amputa-
and gangrene are more frequent causes of amputations in tion was rather high and varied with different diagnoses at
diabetes patients, whether the discharge diagnosis “diabetes” the discharge after procedures.
was excluded or not.
The 30-day mortality in our study was rather high. The
range varied depending on the reason for amputation, from Data Availability
3.46 to 34% in patients with diabetes, to 2.24 to 28.99% in
All data from the database can be obtained upon reasonable
patients without diabetes. In both groups, mortality was
request from Marta Raczynska ([email protected]).
highest in patients with sepsis or acute conditions. We do
not have the data regarding the time sequence of the ampu-
tation procedure and the diagnosis of sepsis or an acute
condition. However, it seems as though those may be a
Conflicts of Interest
consequence of, rather than a reason for, the procedure, Edward Franek is a coauthor of one publication with the
seeing as generally such conditions are at least relative con- guest editor of this issue of JDR. Other authors do not
traindications for surgery. Although there were some differ- disclose any conflicts of interest with regard to this study.
ences in mortality rates between diabetic and nondiabetic
patients, we do not regard them as clinically significant, as
in some diagnoses at discharge categories, mortality is big- Acknowledgments
ger in patients with and in other ones in patients without
diabetes and the percentage differences are rather modest. The study was performed as a part of the author’s employ-
There does not seem to be any regularity with regard to ment. The employers are as follows: Central Clinical Hospital
these results. of the Ministry of the Interior and Administration in
Multiple comorbidities in diabetic patients are reasons Warsaw, Poland (MW and AC), Polish Ministry of Health
for the increased risk of adverse events, including mortality, (MR, KM, and IL), University of Humanities and Economics
in this population. Therefore, it is not surprising that patients in Lodz (WW), and Mossakowski Medical Research Centre,
with diabetes who underwent surgery have higher risks of Polish Academy of Sciences (EF).
Journal of Diabetes Research 7