Original Article

The International Journal of Lower

Extremity Wounds
Incidence and Risk Factors 1–7
© The Author(s) 2024
for Amputations in Persons Article reuse guidelines:
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with Diabetes Mellitus: DOI: 10.1177/15347346241292377

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A Retrospective Cohort Study

Mariana Alves Bandeira, MSc1 , Rosana Nascimento Macedo, MS2,

José Luis Lázaro-Martinez, PhD3 , Yolanda Garcia Alvarez, PhD3,
Michele Neves Brajão Rocha, MSc4 , and
Vera Lucia Conceição de Gouveia Santos, PhD5

Abstract
The aim of this study was to identify and analyze the incidence rate of amputations and their risk factors in people with Diabetes
Mellitus (DM) in two specialized outpatient clinics in Brazil. This is an epidemiological, retrospective cohort study using data
collected from electronic health records of 281 adult diabetic patient types 1 or 2; attended in specialized outpatient service
between 2015 and 2020. Statistical analyses were performed using the 2 sample t-test or Wilcoxon–Mann–Whitney test, for
quantitative variables, and the Pearson’s χ2 test or Fisher’s exact test for categorical variables. The investigation of the risk
factors for amputation was carried out through logistic regression. The study was approved by ethical committee. The sample
mean age was 65.6 years (SD 13.05), predominating male gender n = 211 (75%), type 2 DM n = 223 (86.7%), with cardiovas-
cular disease n = 143 (63.2%), and about 68.7% (n = 156) with peripheral arterial disease (PAD). Seventy-seven had lower limb
amputation (LLA), with a rate incidence of 31.9% during five years. Logistic regression analysis showed the following associa-
tions with amputation: Diabetic peripheral neuropathy increased the rate of amputation by 3.6 times (OR = 3.631, 95% CI =
1.214-11.353; P = .022), and peripheral arterial disease increased by 10 times (OR = 10.631; 95% CI = 2.969-57.029; P = .001).
The LLA in individuals with DM in two specialized outpatient services was higher compared to international literature; DPN
and PAD were confirmed as risk factors for amputation, according to literature. This finding suggests that the study population
faces an increased risk of amputation, highlighting the urgent need for targeted interventions and implementing robust preven-
tive strategies to transform the current scenario and mitigate these severe outcomes. A comprehensive approach is essential to
proactively address the underlying issues and reduce the prevalence and impact of amputations in Brazil.

Keywords
diabetic foot, diabetic foot ulcer, amputation, epidemiology, incidence, enterostomal therapy

Introduction The reamputation rate is also notably significant; accord-

ing to a meta-analysis, the reamputation rate was 19% one
Lower limb amputations (LLA) are defined as the resection year following the initial surgery, increasing to 37.1% at
of a segment of a limb through a bone or a joint.1 They rep- the five-year mark.8
resent late-stage complications that affect individuals with
Diabetes Mellitus (DM), mainly related to male gender,
age, smoking, diabetic foot ulcer (DFU), and peripheral 1
School of Nursing at the University of Sao Paulo, Sao Paulo, Brazil
arterial disease (PAD).2–5 Additionally, it can result from
2
Amico Saúde, São Paulo, SP, Brazil
3
poor metabolic control, lack of health access, and low treat- Complutense University of Madrid, Madrid, Espanha
4
ConvaTec Inc, ConvaCare Clinics, São Paulo, São Paulo, Brazil
ment adherence, aggravated by socioeconomic and racial 5
Department of Medical-Surgical Nursing, School of Nursing at the
disadvantages.6 University of Sao Paulo in Sao Paulo, Sao Paulo, Brazil
It is a frequent and disabling complication. A systematic
Corresponding Author:
review has shown that, between 2010 and 2020, the global Mariana Alves Bandeira, School of Nursing at the University of Sao Paulo,
annual incidence of minor and major amputations was esti- 419 Dr Enéas de Carvalho Aguiar ST, São Paulo, SP 05403-000, Brazil.
mated to be 139.97 and 94.82 cases/100.000 people with DM.7 Email: maribandeira@gmail.com
2 The International Journal of Lower Extremity Wounds

Related to the mortality rate, it is also high, exceeding The data collection consisted in sociodemographic infor-
50% in 5 years,2,9 making amputations an independent mation (age and gender) and clinical data (Diabetes classifi-
risk factor associated with premature death.4 Additionally, cation, body mass index (BMI), smoking, history of alcohol
the negative impact extends to emotional and physical dis- intake, systemic arterial hypertension (SAH), cardiovascular
orders, resulting in a diminished quality of life.10 disease, kidney disease, retinopathy, peripheral arterial
All the previous factors are associated with expressive disease (PAD), glycated hemoglobin (HbA1c), diabetic
costs. In 2014, the Brazilian public health system spent an peripheral neuropathy (DPN) and presence of amputation.
average of $599.8 million for clinical follow-up after ampu- Participants were classified based on BMI as follows lean
tation and $9.89 million in disarticulation surgeries.11 or underweight (≤18.5); normal (18.5-24.9); overweight
The burden of amputations is escalating swiftly, particu- 25-29.9; obesity (>30), being: 30 to 34.9 (class I obesity);
larly in middle to lower-income countries.12 Knowing the 35.0 to 39.9 (class II obesity), and >40 (class III obesity).13
factors, carrying out early patient screening; educational HbA1c levels were classified as follows: <5.7 (normo-
strategies; ulcer treatment; and immediate management of glycemia); ≥5.7 to <6.5 (prediabetes or increased risk for
infection and ischemia can help reduce this condition.10,12 diabetes); ≥6.5 (diabetes).14
However, improvements in health care and preventive Clinical history was obtained from medical records, con-
measures depend on the epidemiological understanding of sidering cardiovascular disease a group of disorders of the
the country and the disease’s impact on the population. heart and blood vessels and including coronary heart
Therefore, given the social and financial impacts of amputa- disease15; kidney disease: the presence of kidney damage
tions and the lack of publications about its epidemiology in or decreased kidney function for at least three months16; ret-
Latin America, this study aims to identify and analyze the inopathy: a microvascular disorder occurring due to the
incidence rate of amputations and their risk factors in long-term effects which involve microaneurysms or worse
people with DM. lesions affecting at least a single eye.17
PAD was confirmed through the ankle-brachial index
(ABI), with a value of ABI < 0.9 indicating PAD.18 DPN
Methods was confirmed using a 12 g Semmes-Weinstein monofila-
This was an epidemiological, retrospective cohort study ment and a 128 Hz tuning fork.12
using data from two private health insurance outpatient The research was approved by Research Ethics
clinics in São Paulo, Brazil. The clinics were units estab- Committee (CAAE: 52574821.9.0000.5533), according to
lished to provide specialized care to people with acute and the resolution No. 466/12 of the Brazilian Ministry of Health.
chronic wounds, including diabetic foot ulcers (DFU). This report followed the Strengthening the Reporting of
Physicians from different specialities, emergency room, Observational Studies in Epidemiology (STROBE) recom-
healthcare teams, or free demand refer the patients. The mendations for cohort studies.19
evaluation and follow-up of the patients are performed by
the enterostomal therapy nurses, following protocols and
Data Analyses
scales for the ulcer assessment.
Data collection was performed from patientś electronic Descriptive statistics were used to summarize the character-
health records. Only the first amputation during the period istics of the sample. The association between amputation
was considered for the incidence calculation. The sample and numerical variables was performed by Student’s t-test
was for convenience, not probabilistic. and Wilcoxon-Mann-Whitney test, and the association
The inclusion criteria were carefully selected to focus on between amputation and categorical variables was carried
type 1 or 2 DM patients aged 18 or older, treated between out by applying Pearson’s Chi-squared test and Fisher’s
2015 and 2020, excluding participants if the amputation Exact Test, according to the data distribution.
was unrelated to DM or if their health records didn’t The Continuous variables with normal distribution are
provide sufficient information. presented as mean ± standard deviation (SD), and the con-
tinuous variables with non-parametric distribution are pre-
Table 1. Incidence of Amputation in People with DM Over a sented as median interquartile range (IQR).
5-Year Period. For the bivariate analyses, the logistic regression was
conducted to explore predictor variables for amputation. A
95% Confidence Interval
significance level of .05 was adopted for all analyses.
Amputation n % Lower limit Upper limit

Total 77 31.9 26.06 37.84 Results

Minor Amputation 60 25.8 20.64 31.87
The study sample consisted of 241 patients. Seventeen were
Major Amputation 8 3.4 1.65 6.77
excluded due to receiving treatment unrelated to DM.
Bandeira et al 3

Seventy-seven had lower limb amputation, with an inci- in China, over nine years, the amputation rate among
dence rate of 31.9% over five years. Most patients suffered patients with diabetic foot ulcers reached 21.5%.20
from minor amputation, resulting in an incidence rate of Additionally, a systematic review documented amputation
25.8% over five years Table 1. incidences ranging from 5.2 to 7.2/ 1000 individuals per
The mean age of the sample was 65.6 years (SD 13.05); year in Australia.24
211 (75%) were male, 223 (86.7%) had type 2 DM, and 143 In terms of amputation levels, this study identified an
(63.2%) had cardiovascular disease, and about 156 (68.7%) incidence of 25.8% for minor amputations and 3.4% for
had PAD. major amputations. Wolosker N, et al, analyzed all lower
Regarding the clinical characteristics of amputated limb amputations performed in the Brazilian public health
patients, most of them had type 2 DM 69 (34.33%); SAH system over a 13-year period, observing an average of 13.96
61 (29.9%); cardiovascular disease 48 (34.78%); DPN 41 major amputations per 100,000 inhabitants per year and
(54.67%) and PAD 63 (40.91%). 17.52 minor amputations per 100,000 inhabitants per year.21
The comparison between groups showed a significant In a recent Australian cohort study, 564 patients from
association between age, HbA1c, male gender, cardiovascu- two public hospitals were analyzed. The incidence of
lar disease, kidney disease, retinopathy, DPN, and PAD, and minor amputations over five years was 34%, and 8% under-
the proportion of individuals who developed and amputa- went major amputations.25 In Japan, the incidence rates
tion (Table 2). were 21.8 per 100,000 person-years for major amputations
The logistic regression (Table 3) found an association and 28.4 for minor amputations.26 A different result was
with the occurrence of amputations and the presence of found in Spain, where the incidence rate was calculated
DPN (OR = 3.631, 95% CI = 1.214-11.353; P = .022) and for each region. The major amputation incidence rate per
PAD (OR = 10.631; 95% CI = 2.969-57.029; P = .001). 100,000 person-years was 0.48.27
Several factors increase the risk of lower limb amputa-
tions in people with DM, related to the individual’s comor-
Discussion
bidities, such as cardiovascular diseases, kidney disease,
LLA related to DM is a severe and common complication in and disease severity. At the same time, socioeconomic prob-
developing countries6; however, the limited data on the inci- lems among ethnic and racial minorities contribute as
dence in Latin America underscores the pressing need for well.6,9,28 Understanding such factors makes it possible to
more comprehensive research. implement preventive measures since amputations are
The incidence reported in the literature varies, with dif- responsible for high mortality rates and adverse effects on
ferences attributed to factors like methodology, sociodemo- quality of life.
graphic disparities, and variations in access and quality of The present study found a significant association
healthcare services among the studied population.20 between the proportion of people who developed amputa-
In this study, the five-year incidence rate of DM-related tion and age, HbA1C, male gender, cardiovascular disease,
amputations was 31.9% in two private services. kidney disease, retinopathy, DPN, and PAD. Other epidemi-
A recente Brazilian study showed that, over the past 13 ological studies presented similar results.29,30
years, a total of 633,455 amputations due to various Another significant finding of our study pertains to age;
causes were performed in the public health system, and patients who underwent amputation were younger, a rela-
DM was identified as the main primary diagnosis associated tionship that has not been previously addressed in the liter-
with amputations. The authors noted that studies on private ature.31 Younger adults presenting with diabetic foot ulcers
healthcare systems were unavailable due to the absence of tend to exhibit more severe and poorly managed disease.6
centralized data services.21 Biagioni et al analyzed all The lack of regular monitoring, unhealthy lifestyle habits,
lower limb amputations performed in public hospitals in and poorly controlled comorbidities can lead to the rapid
Sao Paulo – Brazil; between 2009 and 2020, 180,595 progression of foot complications and increased exposure
lower limb amputations and surgical revision of amputa- to risk factors.28,32
tions were performed, PAD and DM were the leading A national study estimated that approximately one in ten
causes of amputation.22 Brazilians has DM and, 68.2% are aware of their diagnosis,
Therefore, the aligning findings from private healthcare but less than half of these have their HbA1c levels below
settings with those observed in the public health system pro- 6.5%.33
vides a comprehensive understanding of the Brazilian Nonetheless, the results of the logistic regression analysis
scenario. reveal the presence of DPN (OR = 3.631, 95% CI =
In comparison to other countries, our results raise signifi- 1.214-11.353; P = .022) and PAD (OR = 10.631; 95% CI
cant concerns: A previous American study using data from = 2.969-57.029; P = .001) as risk factors for amputation in
Medicare beneficiaries showed a DM-related amputation people with DM on the sample studied. These findings are
incidence of 0.5% between 2006 and 2008.23 In a hospital consistent with other studies.4,30,34–36
4 The International Journal of Lower Extremity Wounds

Table 2. Sociodemographic and Clinical Characteristics of Participants with DM, with and without Amputation.

Variable Without amputation (N = 164) With Amputaion (N = 77)

Continuous Variable Mean ± SD Mean ± SD P

Age (years) – Média ± DP 67.08 ± 11.28 62.96 ± 13.00 .013c

Height (m) – Média ± DP 1.68 ± 0.10 1.71 ± 0.09 .051c
Median (IQR) Median (IQR)
Diabets time (years) 14 (10-20) 14 (10-20) .895d
HbA1c (g/dL) 8.4 (7-10.2) 9.2 (7.5-11.6) .021d
Weight (kg) 84.7 (73.2-95.8) 84 (71-100) .703d
BMI (kg/m²) 29.58 (25.93-33.39) 28.83 (25.14-34.31) .714d

Without amputation With amputation

Categorical variable N (%) N (%) P

Gender
Female 47 (78.33%) 13 (21.67%) .049a
Male 117 (64.64) 64 (35.36%)
Diabetes Mellitus
Type 1 23 (82.14%) 5 (17.86%) .081a
Type 2 132 (65.67%) 69 (34.33%)
Smoking
No 120 (68.97%) 54 (31.03%) .990a
Former smoker 18 (69.23%) 8 (30.77)
Yes 21 (67.74%) 10 (32.26%)
Alcoholism
No 144 (68.90%) 65 (31.10%) .860b
Former Alcoholism 1 (100.00) 0 (0.00%)
Yes 14 (73.68) 5 (26.32%)
SAH
No 19 (65.52%) 10 (34.48%) .617a
Yes 143 (70.10%) 61 (29.90%)
Cardiovascular disease
No 63 (78.75%) 17 (21.25%) .036a
Yes 90 (65.22%) 48 (34.78%)
Kidney Disease
No 107 (76.43) 33 (23.57) .004a
Yes 36 (56.25) 28 (43.75)
Retinopathy
No 110 (78.57) 30 (21.43) <.001a
Yes 29 (51.79) 27 (48.21)
DPN
No 108 (82.44) 23 (17.56) <.001a
Yes 34 (45.33) 41 (54.67)
PAD
No 65 (91.55) 6 (8.45) <.001a
Yes 91 (59.09) 63 (40.91)

SD: standard deviation; IQR: interquartile range; BMI: body mass index, hypertension; SAH: systemic arterial hypertension; PAD: peripheral arterial disease;
HbA1c: glycated hemoglobin; DPN: diabetic peripheral neuropathy.
a
Pearson’s Chi-squared test; bFisher’s Exact Test; cStudent’s t-test; dWilcoxon-Mann-Whitney test.
P < .05 was considered statistically significant.
The statistically significant results are in bold type.

The DPN is an independent risk factor for amputation.34 DPN ulcers.37 The combination of decreased protective plantar sensi-
affects autonomic, sensory, and motor nerves, and when associ- tivity, increased plantar pressure, and sudomotor dysregulation
ated with PAD, it becomes a central cause of diabetic foot makes the patient susceptible to foot ulceration.38,39
Bandeira et al 5

Table 3. Logistic Regression Analysis of Risk Factors for specialized services can significantly enhance the likelihood
Amputation in People with DM. of limb preservation.39,44,45
Confidence Interval
Patients often present with advanced and challenging com-
(95% CI) plications that require highly complex services. It is important
to note that reference services with teams trained to treat foot
Odds Lower Upper complications related to DM are rare in Brazil.
Variable Ratio Limit Limit P Our findings confirm that the Brazilian population faces a
Age 0.978 0.937 1.019 .296 higher risk of amputation, linked to limited access to diabetes
HbA1c 1.093 0.987 1.211 .081 care, socioeconomic disadvantages, social determinants of
Male gender 2.062 0.532 8.814 .306 health, and structural racism, which contribute to significant
Cardiovascular 1.130 0.400 3.239 .817 disparities in amputation rates.6 Assessing socioeconomic
disease status, educational level, housing conditions, and access to ade-
Kidney Disease 1.271 0.396 3.879 .678 quate nutrition is also essential for care planning, given the sig-
Retinopathy 0.824 0.242 2.586 .747 nificant socioeconomic inequality within the population.
DPN 3.631 1.214 11.353 .022 It highlights the urgent need for specific interventions,
PAD 10.631 2.969 57.029 .001 encourages immediate and targeted actions to improve the
HbA1c: glycated hemoglobin; PAD: peripheral arterial disease; DPN:
efficiency of referrals, and ensures more effective and
diabetic peripheral neuropathy. timely management of patients at risk of amputation.
P < .05 was considered statistically significant. Our findings complementary the previous data of public
services and reveal the devastating situation regarding
DM-related amputations in Brazil, in addition to the
Furthermore, the presence of ischemia is considered a similar socioeconomic impact, highlighting that the high
complicating factor associated with impaired healing and incidence of amputations is not only related to public
increased likelihood of hospitalization.40 Reduced or inter- system, as diabetes-related amputations follow similar clin-
rupted blood flow in the lower limbs leads to delays in ical pathways regardless of the healthcare system, amputa-
wound healing, tissue necrosis, gangrene, infection, and tions are a structural problem.
amputation.6,41 According to a meta-analysis, PAD This aspect separates our research from studies conducted
increases the risk of amputation by 2.35 times in individuals in more homogeneous contexts or developed countries. It
with diabetic foot ulcers (95% CI, 1.484-3.718; P < .001).42 also highlighted that DM, PAD and DPN are not being ade-
According to the International Group on Diabetic Foot, quately managed, leading to preventable amputations.
individuals with DPN and PAD have a moderate risk of This study is limited to retrospective data: clinical data
ulceration, but when these conditions are associated with were collected from electronic health records, without PAD
other factors, the risk becomes high, therefore, they classification and severity; in addition, there is no informa-
should be monitored and managed to prevent complications tion about the onset of the disease, making it difficult to estab-
and amputations.43 lish the relationship between amputation and temporality.
However, diagnosing PAD in people with DM can be a Due to the limitations of the health records, it is impossible
big challenge; the symptoms are masked by neuropathy, to get complete information on patients’ medications, proce-
and ankle-brachial index (ABI) values may be falsely ele- dures, and specific ulcer characteristics before amputation.
vated due to medial calcification of peripheral vessels, The sample size is also limited and restricted to two
making the vessels non-compressible, requiring more spe- private outpatient services, which implies that the sample
cific and less accessible exams such as finger index and may not reflect the sociodemographic and clinical diversity
transcutaneous O2 pressure.37,40 of the Brazilian population as a whole. Therefore, partici-
Despite PAD and DPN being widely recognized as risk pants may have health profiles and access to medical care
factors for individuals with DM, these conditions are not that differ from those in less urbanized regions.
being adequately managed due to remaining undiagnosed Future studies that include populations from different con-
for prolonged periods. Other studies confirm the association texts, such as rural areas, are necessary to better understand
between DM and PAD with the high number of amputations the Brazilian epidemiology of diabetes-related amputations.
in Brazil, making the situation more concerning due to the
increasing incidence of major amputations.21,22
Preventive strategies are essential in transforming the
Conclusion
current scenario. Educating patients about self-care, moni- The study revealed a lower limb amputation rate signifi-
toring foot temperature and signs of inflammation, conduct- cantly higher than that reported in international literature,
ing regular assessments by healthcare professionals, and the five years- incidence rate of LLA in individuals with
promptly referring individuals in urgent situations to DM in two specialized outpatient services was 31.9%, the
6 The International Journal of Lower Extremity Wounds

incidence of minor and major amputation was 25.8% e 3.4% 8. Liu R, Petersen BJ, Rothenberg GM, et al. Lower extremity
respectively. reamputation in people with diabetes : A systematic
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between the presence of DPN (OR = 3.631, 95% CI = 2021;9(1):1‐6.
9. Armstrong DG, Swerdlow MA, Armstrong AA, et al. Five
1.214-11.353; P = .022) and PAD (OR = 10.631; 95% CI =
year mortality and direct costs of care for people with diabetic
2.969-57.029; P = .001) with the occurrence of amputations.
foot complications are comparable to cancer. J Foot Ankle
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medical costs of diabetic foot disease in Brazil: A cost of
The authors declared no potential conflicts of interest with respect illness study. Int J Environ Res Public Health. 2018;15(1):1‐13.
to the research, authorship, and/or publication of this article. 12. Schaper NC, Van Netten JJ, Apelqvist J, et al. Practical guide-
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Funding foot disease (IWGDF 2023 update). Diabetes Metab Res
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the research, authorship, and/or publication of this article: This 13. World Health Organization. Body mass index [Internet]. [cited
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