Introduction
Diabetes Mellitus
(DM) is a chronic metabolic disease of diverse etiology characterized by
hyperglycemia and associated with an absolute or relative deficiency in insulin
production, secretion or action. Thus, it can interfere in the metabolism of
carbohydrates, lipids and proteins.1
Currently,
Diabetes is considered a global public health problem and its complications are
becoming the leading cause of morbidity and mortality in the world.2
When not properly treated (mainly evidenced by high blood glucose levels for
extended periods of time), DM can affect the entire body, consequently favoring
the development of a series of acute and chronic complications.3
Therefore, a
multiprofessional approach in the treatment of people with diabetes is
fundamental to achieve favorable results. Hypoglycemia, diabetic ketoacidosis
and hyperglycemic hyperosmolar syndrome are among the main acute complications.
In addition, chronic complications include the following: stroke, myocardial
infarction, chronic kidney disease, blindness caused by diabetic retinopathy,
peripheral arterial disease, peripheral neuropathy and diabetic foot.3
Diabetic foot
is related to sensory-motor and peripheral autonomic neuropathy associated with
various degrees of peripheral arterial disease in the lower limbs of
individuals with DM. It is characterized by the presence of tissue infection,
ulceration and/or destruction.4
It is noted
that, among the complications arising from diabetes, foot ulcers stand out as
one of the main problems and challenges to be faced by health systems. In
Brazil, the costs related to amputations associated with diabetes corresponded
to R$ 17.27 millions. During this same period, the hospitalization
due to diabetic foot deterioration represented 17.83million dollars. This
accounts for a total cost of around 48.4million reais, corresponding to between
40% and 70% of all non-traumatic lower limb amputations.5-6
Among the
infections related to diabetic foot, fungal infections in nail plates and feet
have 45.9% incidence and affect the unilateral areas of the feet. In turn, the
bilateral areas are affected in around 20% of the cases.7 The nail
plate is one of the cutaneous annexes consisting of three horizontal layers: a
thin dorsal plate, an intermediate plate and a ventral layer. As for the
function, the act of protecting the fingers from traumas (defense) and
revealing systemic diseases stands out, mainly to preserve touch.8
Onychomycosis
is defined as a fungal infection that affects the nails, having fungi from
genus Trichophyton and Epidermophyton and exceptionally Microsporum
as main agents. They are more easily installed in people with peripheral
circulatory disorders, decreased resistance, trauma, and maintenance factors
such as profession, climate and hormonal dysfunction.8
It is known
that the treatment route for onychomycosis is oftentimes difficult to choose.
This is because a significant percentage of people with diabetes may not
present favorable health conditions for the implementation of care measures
through classic therapy with systemic medications (antifungal drugs). The
conventional drug treatment can be divided into two: the first one is systemic
via the oral route, using Terbinafine, Itraconazole and Fluconazole. In turn,
the second option refers to topical administration, mainly of the Amorolfine
and Ciclopirox drugs.9
Another
non-pharmacological way to eliminate onychomycosis is Low-Level Laser
Therapy (LLLT). It offers important advantages when compared to drug
treatments, such as lower cost and no adverse effects.7
LLLT is a
therapeutic instrument that consists in emitting low-power and non-ionizing
electromagnetic radiation capable of acting as a biomodulator in cells and
tissues. Therefore, it greatly favors the tissue repair process.10
Laser therapy has been employed as a care technology and used in the assistant
practice of different health areas, including Nursing, in the care of people
with diabetic foot.10
It is worth
noting that the radiation emitted by low-power lasers has shown analgesic,
anti-inflammatory and healing effects. Thus, it is also currently used in the
tissue repair process due to the low energy density employed and its wavelength
capable of penetrating the tissues.11
In addition,
the properties related to the control of disordered tumor cell growth and
antimicrobial action are also highlighted, both achieved through Photodynamic
Therapy (PDT).12 This therapy consists of a combination of
three elements: a photosensitizer, a light source and oxygen. When associated,
they produce localized photo-oxidative injuries capable of acting in various
pathological processes. Thus, the photosensitizers are activated by action of
the light, transferring energy to molecular oxygen and promoting immediate cell
death as a result of this combination.12-13
Bacteria and
fungi are destructed due to the transfer of electrons or hydrogen, thus leading
to the production of TypeI free radicals. But it can also occur by energy
transfer to oxygen (Type II reaction), generating singlet oxygen, a free
radical that promotes death of the microorganism.14Consequently,
this study has the following research problem: Which is the outcomeof using
LLLT and topical drug treatment to eliminate onychomycosis in people with
diabetes?Therefore, the objective of this study was to describe the effects of
LLLT and of topical drug treatment for onychomycosis in people with diabetes.
Method
This is a
quantitative research study of the case-series type, with evaluation before and
after the intervention and developed from October 2020 to August 2021 in the
Clinical Podiatry Nursing Service from an outpatient complex located in a
public health unit in Rio de Janeiro. It is noted that case-series studies
include a description of the characteristics and outcomes among individuals in
a group subjected to an intervention during a given period of time and without
a Control Group.
The
participants were selected by convenience among people with Type II DM treated
at the Clinical Podiatry service and referred with a clinical diagnosis of
onychomycosis. The eligible subjects were those that had not made use of
systemic/topical antibiotics in the last 48 hours prior to entering the
research protocol. People with peripheral arterial disease were excluded from
the study, as well as those who were not able to perform self-care on their
feet, nails and shoes due to cognitive and/or physical difficulties, and
pregnant women.
The convenience
sample selection technique was used for allocation to the groups. After each
interview, the researchers allocated to Group I the participants who were
available to attend the service for LLLT application and, to Group II, the
other participants who, for displacement reasons, could not attend the locus
with the necessary frequency to apply LLLT. Subsequently, they self-applied the
topical medication at their homes. The people included in the study were all
the users referred to this service during the research period, and there were
no withdrawals or refusals regarding participation.
Group I consisted of 9 users who had a total of 27 nail
plates with onychomycosis. They were subjected to the LLLT treatment for onychomycosis.
The individuals allocated to Group II were those with diabetes who underwent
onychomycosis treatment with self-application of topical medication (Ciclopirox
2% in drops), each one at their respective home. Group I consisted of 12 users
who had a total of 38 nail plates with onychomycosis.
The protocol
adopted was a Nursing consultation with a general clinical evaluation and
recording of the following variables: age; gender; glycated hemoglobin dosage
in the last 90 days; foot hygiene condition; previous treatments; and footwear
care. The nail plates were evaluated using an instrument called Onychomycosis
Severity Index (OSI).15OSI is a clinical assessment tool that is
non-invasive and easy to apply to establish onychomycosis severity.
Furthermore, it generates the severity index obtained by the scores
corresponding to the clinical variables related to severity of the nail plate
lesion produced by the fungal infection.
The first score
obtained refers to the nail area affected by onychomycosis. For due
determination, the total nail area was measured with the aid of a caliper and,
subsequently, by measuring the affected nail area. With the results, the
affected area percentage was calculated using simple rule of three. The
following scoring was subsequently applied:15 from 1% to 10% of the
affected area was assigned 1 point; from 11% to 25%, 2 points; from 26% to 50%,
3 points; from 51% to 75%, 4 points; and, if greater than 76%, 5 points (Figure
1).
Figure 1
- Determination of the area affected by Onychomycosis and proximity of the
matrix
Source:
Printed material from the Clinical Podiatry Nursing Service (2021)
The second
score15 is obtained by determining the fungal lesion proximity to
the nail matrix. Thus, the closer to the matrix, the more severe the
onychomycosis and the higher the score. 1 point would also be assigned if
onychomycosis was located in the distal ¼ of the nail, 2 points in the distal
½, 3 points in the distal ¾, 4 points in the proximal ¼, and 5 points if it
reached the matrix, as shown in Figure 1.
The third score15
is obtained by adding 10 points for presence of a longitudinal band, a spot
(dermatophytoma) or for presence of subungeal hyperkeratosis greater than 2 mm.
After evaluating all scores, the area score value is multiplied by the matrix
proximity score value to the result of this operation. Subsequently, another 10
points are assigned regarding presence of dermatophytoma and/or subungual
hyperkeratosis. The result is the OSI index, which can vary between mild, with
a total score of 1 to 5, moderate from 6 to 15, and severe from 16 to 35.15
After the
initial evaluation, all the participants were subjected to podoprophylaxis
(podiatric technique consisting in nail plate cleaning, thinning and sanding).
Its objective is to remove the parts affected by the fungal infection and
provide equal conditions for penetration of the treatments proposed.
The
participants allocated to Group I underwent 10 LLLT sessions with PDT therapy
with a 7-day interval between each session, totaling 10 weeks of treatment.
This technique consisted in applying methylene blue solution at a 0.5%
concentration on the nail plate. After applying the blue dye, 5 minutes were
allowed for the photosensitizing solution to be impregnated throughout the nail
and LLLT was subsequently applied. An Easy Laser model laser equipment was
used, patented by the Ricardo Trajano Institute in 2009 and registered at the
National Health Surveillance Agency (Agência Nacional de VigilânciaSanitária, ANVISA)
under number 80030819009.
The Easy Laser
equipment has 100 mw power, with simultaneous emission of red and infrared
lasers. It offers red laser beam and low-power infrared laser emission and has
a wavelength of 808nm and 660nm (nanometers), respectively, in continuous mode.
Transmission of the lasers by means of optical fiber allows emitting a
collimated and highly-directed light beam to the tissue.
Nail plate
irradiation was used to perform PDT. Simultaneously, the low-power red laser
beam with 660nm wavelength and 12 Joules per square centimeter dosimetry
was used.
The
participants allocated to Group II received 1 vial of 2% Ciclopirox olamine in
drops and were instructed to apply one drop every 12h on the affected nail
plate for 10 weeks. Thus, all participants were re-evaluated 6 months
after performing the interventions through the OSI.15 Such period
was necessary because of the slow growth of the foot nail plates of the
individuals involved. The OSI assessment was performed on all study
participants in both groups (pre- and post-treatment), and it score used to
verify the outcome. As a result, it was possible to verify that onychomycosis
can be cured with OSI = 0, that onychomycosis improves when
Pre-OSI> Post-OSI, that onychomycosis is maintained when Pre-OSI = Post-OSI,
and that onychomycosis worsens when Pre-OSI < Post-OSI.15
Once data
collection was concluded, the results were organized in a Microsoft Excel 2010
database and subsequently analyzed by means of descriptive statistics. A simple
data survey in the SPSS software was made to investigate the variables.
The OSI15
scores were compared before and after the treatment in each group and,
subsequently, their clinical cure rates were compared. For being a descriptive
research study, no statistical or significance tests were applied to compare
the samples.
The study
follows the recommendations set forth in Resolution No. 466/2012 of the
National Health Council, which regulates research studies involving human
beings. In addition, it was submitted to the institution's Research Ethics
Committee via Plataforma Brasil, obtaining positive opinion on
April 29th, 2022, with number 5,379,029.16
Results
In groups I and
II, respectively, the highest distribution by age group corresponded to
individuals over 60 years old and with a frequency of 89% (n=8) and 58% (n=7).
The others belonged to the adult age group from 19 to 59years old:
11% (n=1) and 42% (n=5). It is worth noting that the mean age was
66/67 years old.
It was observed
that, in Group I, no individual had HbA1c > 6.5%, normality/pre-diabetes
range; that 55% (n=5) had HbA1c between 6.6% to 7.5%, glycemic control range;
and that 45% (n=4) had HbA1c between 7.6% to 20%, where there is no therapeutic
glycemic control.6
In Group II,
16% (n=2) of the subjects presented HbA1c > 6.5% (normal/pre-diabetes
range), 9% (n=1) had HbA1c between 6.6% to 7.5% (glycemic control range) and
75% (n=9) had HbA1c between 7.6% to 20%, where there is also no therapeutic
glycemic control.
In
Group II, it was verified that more than 70% of the participants presented
uncontrolled glycaemia. However, it should be noted that the population
included in this group is greater than that of the first one, as can be seen in
Table 1, which shows the characteristics related to the nail changes presented
by the individuals in both groups:
Table 1- Characteristics related to the
nail lesions presented by the individuals – 2022.
|
Description
|
Group I (n=9)
|
Group II (n=12)
|
|
|
n
|
%
|
n
|
%
|
|
Foot
hygiene condition
|
|
|
|
|
|
Good
|
8
|
85
|
7
|
60
|
|
Reasonable
|
1
|
15
|
5
|
40
|
|
Bad
|
-
|
-
|
-
|
-
|
|
Shoe hygiene performed
|
|
Yes
|
7
|
78
|
2
|
26
|
|
No
|
2
|
22
|
10
|
74
|
When analyzing
the characteristics presented in Table 1, which corresponds to the performance
of a previous treatment for the injuries, Group II displays a higher percentage
of individuals who have already undergone it in relation to Group I. In
relation to the hygiene condition and to performing footwear hygiene
procedures, the population included in Group I presents higher rates of foot
hygiene and footwear cleaning habit when compared to Group II. Table 2
below evidences the changes in the nail plates before and after the treatments.
Table
2 - Nail plate changes before and after the interventions –
2022.
|
Changes
|
Group I (Pre)
|
Group I (Post)
|
Group II (Pre)
|
Group II (Post)
|
|
n
|
%
|
n
|
%
|
n
|
%
|
n
|
%
|
|
Dystrophy
|
20
|
93
|
10
|
46
|
38
|
100
|
13
|
25
|
|
Detachment
|
18
|
67
|
6
|
22
|
21
|
55
|
22
|
58
|
|
Altered
Color
|
27
|
100
|
11
|
41
|
37
|
97
|
28
|
27
|
When analyzing
the changes found in the nail plates in both groups, before and after the
interventions proposed, it was identified that nail dystrophies presented a
reduction after applying both interventions. The reduction in groups I and II
were 50% and 34%, respectively.
As for nail
detachment, it was verified that Group I presented a 66% reduction to the
proportion that there was a 4% increase in Group II. Regarding color change,
the percentage from Group I had a 60% reduction while a 25% drop was recorded
in Group II.
After comparing
the data referring to the changes found in the nail plates in the groups (after
the interventions), it was possible to identify that the one subjected to laser
therapy presented a greater reduction proportion in the changes when compared to
the drug treatment.
Table 3
shows the Onychomycosis Severity Index comparison in both groups before and
after the interventions proposed.
Table 3 - Onychomycosis
Severity Index before and after the interventions – 2022.
|
Index
|
OSI
(PRE)
|
OSI
(POST)
|
|
n
|
%
|
n
|
%
|
|
Group I (n=27)
|
|
|
|
|
|
Clinical
Cure
|
-
|
-
|
8
|
30
|
|
Mild
Severity
|
2
|
7
|
1
|
4
|
|
Moderate
Severity
|
4
|
15
|
6
|
22
|
|
Extreme
Severity
|
21
|
78
|
12
|
44
|
|
Group II (n=38)
|
|
|
|
|
|
Clinical
Cure
|
-
|
-
|
10
|
26
|
|
Mild
Severity
|
9
|
24
|
6
|
16
|
|
Moderate
Severity
|
4
|
10
|
6
|
16
|
|
Extreme
Severity
|
25
|
66
|
16
|
42
|
When analyzing
OSI after the interventions, it was identified that groups I and II achieved a
cure, according to OSI. In other words, nearly 30% of the nail plates treated
in the first group had satisfactory clinical results. Similar success was
noticed in the second: nearly 26%. Another relevant data when assessing
the post-intervention OSI values in the groups refers to extreme severity. In
these cases, the intervention performed in Group I promotes a 34%
reduction, whereas the reduction was around 24% in Group II.
To demonstrate
the response obtained after performing the interventions in each group, and
using the OSI values obtained after the treatment as a metric, the responses to
the interventions were grouped. The nail plates that presented OSI = 0
(clinical cure) and/or a score reduction after the intervention were
categorized as satisfactory responses to the intervention. Those that
maintained the OSI values or presented an increase in the post-intervention
scores were categorized as not satisfactory response to the intervention.
Table 4 describes the results obtained.
Table4
- Comparison of the response to the intervention between
GroupI(n=27) and Group II (n=38) – 2022.
|
Response
|
Group I
|
Group II
|
|
n
|
%
|
n
|
%
|
|
Satisfactory
|
17
|
63
|
20
|
53
|
|
Not
satisfactory
|
10
|
37
|
18
|
47
|
It was
evidenced that there was prevalence of satisfactory responses in both groups.
In Group I, for example, favorable results were found in 63% of the plates
treated. In Group II, which corresponds to 53% of the participants, a
higher frequency of beneficial effects was observed in individuals who
underwent laser therapy than among those who were subjected to topical drug
treatment.
Discussion
The most
prevalent age segment in both groups corresponded to elder participants. This
is due to the fact that 50% of them have Type 2 DM and are over
60 years old. This fact is important, as physiological debilitations take
place as a result of aging.17-18
Another detail
to be added is the occurrence of mycoses. For example: nearly 10% of the
general population is affected by onychomycosis. Of them, 20% are aged over
60 years old and 50% of the people affected are at least 70 years
old.19
Regarding
adequate control of the glucose levels, absence of glycemic control is related
to low adherence to the treatment. A study20 shows that 38% of the
patients involved did not adhere to the drug treatment and that 28% were not
adherent to the full treatment (drug plus non-drug).
A research
study21 highlights the importance of glycemic control, as
decompensated diabetics are more likely to suffer micro- and macro-vascular
complications. Thus, they are more susceptible to infections such as
onychomycosis, as they can also show deficits in their immune system.22
In addition,
footwear hygiene is highlighted as one of the main preventive measures against
onychomycosis reinfections.23 Foot hygiene is also a strong ally in
the treatment of fungal contamination in older adults. In some cases, it is
even the only viable treatment since, due to financial problems, topical
medications are oftentimes very expensive. In addition to that, there is also
each user's clinical issue, something that precludes drug interaction and use
of systemic medications.24
This research
that investigated onychomycosis showed that the participants from both groups
presented clinical signs of the disease before the treatment. Nail dystrophy,
onycholysis (separation of the nails from the nail bed), color change, frailty
and thickening of the nails are some of these signs.8
In conjunction
with a compatible photosensitizer and in the presence of oxygen, LLLT
chemically produces by-products. Thus, Reactive Oxygen Species (ROS) acting on
cell membranes increase their permeability, penetrate the fungal cells, and
cause damage to other intracellular organelles.25
Ciclopirox acts
by inhibiting the metal-dependent enzymes. In this way, there is damage to ion
transport through the cytoplasmic membrane, to degradation of toxic peroxides,
to nutrient intake, and to protein and nucleic acid biosynthesis.26
A research
study27 compared the use of high-frequency waves and laser in the
onychomycosis treatment. The laser used was Flash Lase III (with 660 nm
wave emission) and the photosensitizer was 0.5% methylene blue. It was
concluded that users treated with PDT had visible improvements immediately
after the second application. Thus, it enhanced efficacy and advantage of the
treatment and corroborated this study, as it benefited the nails affected by
onychomycosis and treated with LLLT.
It is also
worth mentioning that the research used an Nd:YAG 1064 laser, whose result was
63% clinical improvement 3 months after the last session. Therefore, it
highlights laser as a safe and effective treatment with no significant adverse
effects and well-accepted by the participants.28 Another research
study evaluated 40 participants with onychomycosis who were treated with
Ciclopirox. It was verified that 22% achieved complete cure (clinical and
mycological) after 9months of treatment. Unfortunately, despite the low cure
percentage, the authors indicate the medication as a viable option for
participants who cannot tolerate the systemic treatment.29
As limitations,
we should emphasize that the participants from Group II were not monitored
periodically and weekly as Group I. Therefore, it can be inferred that they
would have more clarifications regarding daily foot care than those from Group
II. Thus, this may have had repercussions on the study result for Group I with
a higher clinical cure rate. Consequently, the comparison of heterogeneous
groups can exert an influence on the results. In addition to that, the research
does not intend to generalize its results, suggesting other surveys in
different settings and contexts.
This study
sought to describe the results obtained in the onychomycosis treatment in
people with diabetes by means of LLLT and topical drug treatment. The objective
was also to enhance care quality for this clientele and to direct, in a
scientific way, the assistance provided by nurses specialized in Podiatry.It is
noted that Clinical Podiatry emerged in Brazil from 2007 with the leading role
of Nursing through the creation of the 1st Specialization Course at Universidade
Federal de São Paulo (UNIFESP).
Podiatric
nurses (specialized in Clinical Podiatry) play an indisputable role in the
evaluation of lower limbs, as indicated in the guidelines on diabetic foot
prevention and treatment. Additionally, in order to promote health through
early diagnosis, analyzing the signs and symptoms with prudence and
responsibility is a sine qua non condition for success. In other words,
it is necessary for professionals to be able to expand the capacity to mobilize
and solve complications resulting from diseases (whether acute or chronic);
and, thus, minimize the implications that could result in possible amputations.10
Another benefit
of this study is the fact that it generates subsidies for future research on
LLLT in the Clinical Nursing practice for people with diabetes. Consequently,
it will be possible to show to Nursing professionals the importance of LLLT as
a therapeutic instrument, as it provides specialized, effective and
economically more viable Nursing assistance when compared to other
technologies.
Conclusion
Given the above, when describing the results obtained
with LLLT and the use of topical medication in onychomycosis in people with
diabetes, it was verified that the laser therapy presented higher prevalence of
satisfactory responses and clinical cure than the topical medication treatment
in the groups investigated.
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Authorship contributions
1 –
Eugenio Fuentes Pérez Júnior
Nurse.
PhD in Nursing - eugenioperezjunior@gmail.com
Research design and development,
writing of the manuscript, review and approval of the final version.
2
–
Cleo Macedo Paula
Nurse - cleomacedop@gmail.com
Research design and development,
writing of the manuscript, review and approval of the final version.
3 – Ariane
da Silva Pires
Nurse.
PhD in Nursing - arianepiresuerj@gmail.com
Research design and development,
writing of the manuscript, review and approval of the final version.
4 –
Alessandra Sant Anna Nunes
Nurse.
PhD in Nursing - asantnunes@gmail.com
Review and approval of the final version.
5 –
Francisco Gleidson de Azevedo Gonçalves
Corresponding
Author
Nurse,
MSc in Nursing - gleydy_fran@hotmail.com
Review and approval of the final version.
6 – Kelly
Fernanda Assis Tavares
Nurse,
MSc in Nursing - kfassis@yahoo.com.br
Review
and approval of the final version.
Scientific Editor: Tânia Solange Bosi
de Souza Magnago
Associate Editor: Etiane de Oliveira
Freitas
How to cite this article
Pérez Júnior EF, Paula CM, Pires AS, Nunes
AS, Gonçalves FGA, Tavares KFA. Laser therapy and topical
drug treatment for onychomycosis in people with diabetes: A case series study.
Rev. Enferm. UFSM. 2023 [Access on: Year Month Day]; vol.13, e31:1-16. DOI: https://doi.org/10.5902/2179769274448