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Prevention strategy of ulcer recurrence

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This cross-sectional,cross-sectional, one-group, pre-post-teaching study was carr


ied out on 60 first year nursing students from a professional teaching institute i
n Maharashtra A non-probability convenience sampling technique was used for this s
tudy. Before initiating the study, students were explained about the study's proce
dures and objectives, and then consent was taken from all the participants. Those
who were not willing to participate were exempted.exempted

With best regards

Editorial team

Editorial team’s comments:

In all sections of the article

1. Arrange article sections as the following order

Introduction, Materials and Methods, Ethical considerations, Results, Discussion, Conc


lusion, References, Tables

2. Remove italics and bolded from the word and sentences


3. Remove dent from the begging of paragraph
4. Please integrate the separate paragraphs together all through the article.
5. Please write what the abbreviation stands for, if appeared in the text for the first time.
Before the abbreviations, the first letter of each word should be written in c
apital letters

For example: Iranian Journal of Nursing and Midwifery Research (IJNMR)


6. Please mention mean (SD) Before reporting their values
7. In cases when p=0.000 replace it with p<0.001 all through the article.
8. Please integrate the separate paragraphs together all through the article.
9. Except p-values, round numbers after point up to two digits all through the article an
d tables consistently. If the second digit after point is zero, add 0 , for example, 5.20.

Abstract

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Prevention strategy of ulcer recurrence

1. Arrange abstract sections as the following order

Background, Materials and Methods, Results, Conclusions, Keywords


2. Abstract should not exceed 250 words 
3. Results of statistical tests (if significant for T, F …..)and df and relevant p v
alues should be mentioned the result of the abstract and the article: for ex
amples:

(F1,67=1089, p<0.001).

(t54=2.39,p=0.01)

(χ2=15.79, df=1, p<0.001(

4. Check your key words in mesh

Introduction

Mention the introduction in 2 or 3 paragraphs

Materials and Methods

1. Please add the year of the study at the beginning of the materials and methods.
1. sections)
2. Please mention how the sample size was calculated? (Provide power, Sig,...). The form
ula is not needed to be written. Write the exact values and all components of the for
mula. For example: sample size was calculated according to power analysis with z1=...,
z2=..., r=... ()
3. Please write the type of the study at the beginning of the methods.
4. Please provide complete name and the manufacturer details of the SPSS

Ethical considerations

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Discussion

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mitation does not need a separate section)

References

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10 years old.

Tables

1. Please Cite the number of tables in the article sequentially(first cite the number of
1 and then 2,3,4…)
2. Avoid using mean +- SD but use mean(SD) in a unique column

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Prevention strategy of ulcer recurrence

3. Avoid mentioning percentage in a separate column. Please report that in a unique colu
mn in parenthesis.N(%)
4. Please put the statistics in the head of columns in all tables. For example: Mean (SD)
or N(%).
5. Please expand the abbreviations under the table.
6. First report the statistical test results (such as F) and then df and then p-values.
7. Please integrate mean and standard deviation’s columns together, for example:
mean (sd) all through tables.

Figure.

1. if you have downloaded this figure, send it copyright

reviewers’ 1 comments: as the followings


Comments For Editor: 

Strengths:
1. The topic is important and can add important ideas to the literature. 
2. The importance of the study is mentioned clearly. 
3. The objectives are mentioned clearly. 
4. The data collection procedure is explained in detail. 

Weaknesses/Revisions:
1. There are a lot of grammar issues. The writing is not academic. English proofreading
is recommended.
2. The writing style is not based on the academic style that is recommended by the
journal. 
3. The title contains unnecessary words: "In Home Care Settings at Pontianak,
Indonesia". Mentioning settings is not recommended to be in titles unless studies are
epidemiological. Settings should be mentioned in Methods. 
4. The abstract needs revisions; adding an introductory sentence and mentioning the
main findings in Results. 
5. Introduction is not literature review! The written Introduction needs a lot of revisions;
especially the first 5 sentences and last 5 sentences in P.2. 
6. The research question or hypothesis are NOT mentioned clearly. 
7. Sampling criteria should be mentioned in detail. There should be mutual criteria
between the study and control group because this is an experimental study regarding a
complication in DM. Many factors can be biases while conducting this experimental
study.  
8. The most important thing is this study is the preventive strategies. It is not clear how
the researcher decided to use specific strategy rather than others. Based on which

3
Prevention strategy of ulcer recurrence

criteria the researcher did that!? Is there any evidence? If yes, the study does not add
anything to literature. If no, the strategy is not valid and reliable. 
9. One of the strategies that the researcher used is "skin moisturizers". It is not clear
what type! For how long! Interval! etc.  I use this strategy as an example. Other
strategies need more explanations and clarifications. 
10. How has neuropathy been assessed? 
11. How has foot deformity been assessed? 
12. It is not clear that "wound classification tool" is a valid and reliable tool. No citation.
no permission, nothing! 
13. The Results are very weak. The data analysis does not tell the readers about the
findings. 
14.  The recommendations did bring and thing new!
15. Most of the references do not have DIOs. 

Comments For Author: 

Strengths:
1. The topic is important and can add important ideas to the literature. 
2. The importance of the study is mentioned clearly. 
3. The objectives are mentioned clearly. 
4. The data collection procedure is explained in detail. 

Weaknesses/Revisions:
1. There are a lot of grammar issues. The writing is not academic. English proofreading
is recommended.
2. The writing style is not based on the academic style that is recommended by the
journal. 
3. The title contains unnecessary words: "In Home Care Settings at Pontianak,
Indonesia". Mentioning settings is not recommended to be in titles unless studies are
epidemiological. Settings should be mentioned in Methods. 
4. The abstract needs revisions; adding an introductory sentence and mentioning the
main findings in Results. 
5. Introduction is not literature review! The written Introduction needs a lot of revisions;
especially the first 5 sentences and last 5 sentences in P.2. 
6. The research question or hypothesis are NOT mentioned clearly. 
7. Sampling criteria should be mentioned in detail. There should be mutual criteria
between the study and control group because this is an experimental study regarding a
complication in DM. Many factors can be biases while conducting this experimental
study.  

4
Prevention strategy of ulcer recurrence

8. The most important thing is this study is the preventive strategies. It is not clear how
the researcher decided to use specific strategy rather than others. Based on which
criteria the researcher did that!? Is there any evidence? If yes, the study does not add
anything to literature. If no, the strategy is not valid and reliable. 
9. One of the strategies that the researcher used is "skin moisturizers". It is not clear
what type! For how long! Interval! etc.  I use this strategy as an example. Other
strategies need more explanations and clarifications. 
10. How has neuropathy been assessed? 
11. How has foot deformity been assessed? 
12. It is not clear that "wound classification tool" is a valid and reliable tool. No citation.
no permission, nothing! 
13. The Results are very weak. The data analysis does not tell the readers about the
findings. 
14.  The recommendations did bring and thing new!
15. Most of the references do not have DIOs. 

 
Other reviewers’ comments: as the followings file:

Prevention Strategy of Ulcer Recurrence in Patients with Type II Diabetes Mellitus In

Home Care Settings at Pontianak, Indonesia

Abstract

Background: There are many strategies to prevent diabetic wound recurrence, but the most

effective strategy does not yet exist. This study was to evaluate the effectiveness of

prevention strategy in reducing the incidence of ulcer recurrence in patients with diabetes

mellitus (DM).

Materials and Methods: quasi-experimental study with convenience sampling was

conducted. Two trained nurses as study assistants participated in this study. The samples

were divided into two groups: The intervention group received treatment with prevention

strategy, including examination and assessment, foot care, and educational program. In

contrast, the control group received standard of care.

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Prevention strategy of ulcer recurrence

Results: Sixty patients with type II DM were recruited. An equal number of men (n = 30)

and women (n = 30) participated in the study. Moreover, 83.3% of patients in the control

group and 76.7% in the intervention group do not smoke. Neuropathy was noted in 76.7% of

patients in the intervention group and 56.7% in the control group. Furthermore, 63.3% of

patients in the control group and 56.7% in the intervention group had foot deformity. This

study presented that ulcer recurrence was 33.3% in the control group and 13.3% in the

intervention group. The duration of the presence of DM in both groups was > 9 years (50.0%

in the intervention group and 43.3% in the control group. There were no significant

differences between the intervention group and control group, mean (SD) in age (t 29 =

−0.874, p = 0.389), ankle-brachial index ( t29 = -1.052, p = 0.144), and HbA1C (t26 = -

0.345,p = 0.733).

Conclusion: The prevention strategies combining examination and assessment, foot care, and

educational program can reduce ulcer recurrence in patients with DM.

Keywords: Prevention, ulcer recurrence, diabetic patient

Introduction

A diabetic ulcer is one of the most feared complications of diabetes mellitus (DM). Although

amputation can save the patient’s life, the mortality rate is still high.[1] A study in Indonesia

reported that the prevalence of diabetic foot ulcers was 12%.(2) Another study reported a

global diabetic foot ulcer recurrence rate of 4.3%–44.4%.[3] In Indonesia, two studies reported

that the incidence rates of diabetic ulcer recurrence were 43% and 54.3%.[1,4] The incidence

of ulcer recurrence in patients with DM is still high compared with the global diabetic foot

ulcer recurrence rate of 4.3%–44.4%.[3] Therefore a measure to prevent ulcer recurrence in

patients with DM should be established as early as possible. [5] Furthermore, a study has been

conducted to investigate the prevention of ulcer recurrence in patients DM, including use of a

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Prevention strategy of ulcer recurrence

self-assessment tool, infrared temperature measurement, self-management, use of therapeutic

footwear, integrated foot care, pressure offloading, and patient education.[6,7,8,9]

A strategy for preventing ulcers in patients with DM includes identifying the foot at risk;

examining and inspecting the foot, using appropriate footwear; providing health education to

patients, families and healthcare providers; and treating the foot at risk of ulcer. [10,11] An

educational program that can be provided to patients with DM in preventing ulcers includes

glycemic control education and advice on diet, exercise, and medication.[12] Another

prevention strategy is integrated foot care that includes professional foot care, patient

education, use of therapeutic footwear, and prevention of ulcer recurrence. [13] Another study

found that thermography can detect patients at risk for foot ulcers in those with DM. [14,15] In

Indonesia, many hospitals have diabetic foot clinics. However, ulcer prevention of foot at risk

with integrated foot care strategies has not been performed optimally, such as the use of

therapeutic footwear. Currently, almost all polyclinics are still using conventional standard

strategies in preventing ulcers and recurrence with the five-pillar method based on PERKINI

2011.[16] PERKINI is an abbreviation of the Indonesian Endocrinology Association, which

stipulates the management of DM that consists of five pillars including diet, physical

exercise, medication, glucose monitoring, and education. Although the five pillars program

from PERKINI has become a national program and is being implemented, the incidence of

ulcer recurrence is still high. In preventing ulcer recurrence in diabetic patients, nurses are

health care providers who play a very important role and are actively involved in early

detection of diabetic patients. The role of the nurse is to carry out a physical examination and

assessment, giving foot care and educational programs in the context of preventing diabetic

foot ulcers.

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Prevention strategy of ulcer recurrence

Various of prevention strategies have been studied and carried out to prevent ulcer

recurrenace in diabetic patients. From several literature studies, both original articles and sys

tematic reviews, it was found that from various studies on prevention of ulcer recurrence, unf

ortunately, the most effective strategy for preventing recurrent wounds has not been found. In

Indonesia, the high incidence of ulcer recurrence must be prevented; therefore, the use of

strategies to prevent ulcer recurrence needs to be conducted. This study used a combination

strategy to prevent ulcer recurrence in patients with DM: (1) Physical examination and

assessment of the foot (10)(17) includes the use of a thermograph to detect skin temperature

(14); monofilament test; ankle brachial index (ABI) determination; foot deformity detection;

foot plantar pressure measurement; detection of callus and corn and skin disorders, such as

dryness and fissures; and patient history taking. 2. Foot care includes removal of the callus,

foot hygiene, and use of skin moisturizers. (3) Patient education includes regular blood sugar

control, diet management, exercise, regular foot inspection, medication, and use of footwear

following the results of pressure measurements on the plantar foot. Therefore, this study aims

to evaluate the effectiveness of prevention strategy in reducing the incidence of ulcer

recurrence in patients with DM. The following research question was formulated: How effect

ive at strategy preventing ulcer recurrence is including physical examination, foot care and

education program in patient with DM?

Materials and Methods

The study was conducted in Kitamura wound clinic at Pontianak City and home care seting,

Indonesia, from August 2020 to August 2021. In order to determine the sample size, compari

son of ratios formula was perfomed and α=0.05, β=0.95, p1=0.12 and p2=0.54 were consider

ed. Based on the calculated sample size, 2 groups of 30 people (total of n=60 samples) were d

esigned. The sample size was calculated using G*Power software analysis.[17] This study

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Prevention strategy of ulcer recurrence

employed a quasi-experimental, non-equivalent control group design to evaluate the

effectiveness of a strategy for preventing ulcer recurrence in patients with DM. Both of

groups were recruited through convenience sampling. The inclusion criteria of samples were

recovery from ulcers for > 2 weeks, absence of complications of kidney and heart disease,

ability to perform daily activities, and ability to cooperate. Exclusion criteria were: foot infect

ion; foot ulcer active; Charcot neuro-osteoarthropathy; chronic limb-threatening ischemia; cu

rrent use foot temperature monitoring and severe illness or complication.

The intervention group and the control group consisted of patients who had been treated at

the clinic and recovered from their wounds. Both groups were identified by searching

medical records and then the researcher made contact person with telephone and mobile

phone. After screening for and confirmation of eligibility, willing participants provided infor

med written informed consent prior to enrolment. As many as 60 patients who are willing to

participate in the study, then divided into intervention and control groups. In the intervention

group, patients were invited to come to the clinic if they were not able to attend and patients

who were unable to come to the clinic, the researcher visited and intervened at home. While

in the control group, the researcher visited the patient's house directly. The intervention group

received treatment, while the control group did not receive treatment or comparison purpose.

In the control group, follow-up care was performed according to the standard of care

provided by the healthcare provider using leaflets about the care of patients with DM using

the five pillars, including ulcer prevention.

Two study assistants were trained on DM foot examination, including the use of tools for foot

examination, such as the thermograph, monofilament test, vascular Doppler ultrasonography,

and conventional foot plantar scan; diabetic foot and nail care; demographic data collection;

diabetic wound assessment; and patient education for a patient with DM under the study

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Prevention strategy of ulcer recurrence

protocol. In the intervention group, patients underwent examination and evaluation of the foot

including deformity, foot care, and education. Data collection procedures were conducted for

1–1.5 h, including the intervention. The intervention group was routinely controlled once a

month after examination and inspection. Foot care and education were provided at the

beginning of the assessment. Then, twice a month, the patient was controlled for up to 6

months.[18] During the control period, activities regarding tips on diabetic foot care foot, diet,

exercise, skincare with moisturizing cream (cerave cream; a skin moisturizing cream

recommended by a dermatologist) which is applied to the entire skin of the feet except on the

soles of the feet and between the toes once every day, medication, use of footwear according

to the distribution of plantar imprint, callus removal, and emotional control were monitored,

and abnormal early signs in the feet, such as callus, dryness, fissures, and nail changes, and

signs of ulcer, warmth, swelling, abnormal skin color (blue or black as ischemia symptom),

and interdigital fungal infection (tinea pedis) were identified. Meanwhile, primary DM

education was conducted for the control group, including DM management, medication, diet,

exercise, and foot care with a booklet. They received follow-up care at the healthcare center

in their location. In the control group , monitoring was conducted once a month for six

months by visiting patients at home and/or calling and assessing foot condition if there were

ulcers and capturing a photograph. The treatment was discontinued in patients with ulcers,

and they were advised to visit the wound clinic immediately.

In this study, several procedures were applied for data collection, including vascular Doppler

ultrasonography to examine the ABI (ankle-brachial index), monofilament test to examine

neuropathic status (20): if sensation of a 10-g monofilament was diminishied, the patient was

dianogsed as having sensory neuropathy, use of traditional plantar pressure devices to

determine the pressure distribution in the plantar area, [19] and use of a callus removal device.

The patient was clinically examined for structural and functional foot deformities such as:

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Prevention strategy of ulcer recurrence

claw/hammer toe, hallux rigidus, hallux valgus, bony prominence, pes cavus, pes planus and

metatarsal head (22). Other procedures were thermography to detect skin temperature, [20]

blood pressure examination, demographic data assessment, and use of a wound classification

tool. An assessment tool of the Texas University wound classification system that was

widely used to assess the presence and absence of ulcers in the two groups.[21] Skin

breakdown was assessed or discharged with superficial ulcer and presented clinically as an

abrasion and blister.

Ethical consideration

This study was approved by the ethics committee board of the Institute of Nursing of

Muhammadiyah Pontianak (no.96//KEP/II.I/AU/D/2020 – Februari 23, 2020 ). Patients were

informed of the study objectives and provided written consent before data collection. They

could refuse to participate in the study at any time without any consequences.

Data analysis

Descriptive analysis was performed to determine the characteristics of the patients with and

without ulcers and characteristic differences between patients in the two groups using t-test

with P < 0.05 was considered statistically significant. The Statistical Package for the Social

Sciences into SPSS (version 22; SPSS Inc., Chicago, Ill., USA) for Windows was used in

this study.

Results

In table 1b, the numbers of female and male respondents in both groups were equal (56.7%).

The smoking status was 83.3% of patients in the control group and 76.7% in the intervention

group (table 1a). Neuropathy was noted in 76.7% of patients in the intervention group and

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Prevention strategy of ulcer recurrence

56.7% in the control group. Furthermore, 63.3% of patients in the control group and 56.7% in

the intervention group had foot deformity. This study found that the incidence of ulcer

recurrence was 33.3% in the control group and 13.3% in the intervention group. The duration

of the presence of DM in both groups was > 9 years (50.0% for the intervention group and

43.3% for the control group). In table 1b, there were no significant differences between the

two groups, the mean (SD) of participatns in age, ABI, and HbA1C : 62 (10.46) and 59.67

(11.48) years; 1.169 (0.24) and 1.089 (0.19); and 9.27 (2.13%) and 9.03 (2.73%), in the

intervention group and control group, respectively.

Discussion

This study aims to evaluate the effectiveness of a prevention strategy in reducing ulcer

recurrence in patients with DM. The ulcer recurrence rate in the control group was higher

compared to that in the intervention group. The ulcer recurrence rate was still high in the

intervention group compared to the global ulcer recurrence rate of 4.3%. [3] However,

compared with the incidence of ulcer recurrence in the first year after healing, which was

predicted to be approximately 40%,[22] it was lower in the intervention and control group in

this study. Our study found that neuropathic conditions in the intervention group were greater

in number than in the control group, which is a major risk for injury in diabetic patients (25).

It can be concluded that the combination of prevention strategies is likely to be effective.

Ulcer recurrence in patients with DM is common. This study showed that most patients had

ulcer recurrence in both groups < 6 months after healing, indicating that the ulcer recurrence

rate may still be high within 1 year. This remains a concern for practitioners because it has

been predicted that ulcer recurrence rate in patients with DM was 60% after healing in 3

years and 65% after healing in > 5 years.[22] However, it is still a concern for patients with

DM recovering from ulcers to prevent recurrence as early as possible. Therefore, identifying

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Prevention strategy of ulcer recurrence

other factors that may contribute to ulcer recurrence is necessary. Factors that cause ulcer

recurrence include minor ulcers, longer duration of foot ulcers and location of previous foot

ulcers, smoking, neuroischemia, irregular blood sugar control, bone infections, and elevated

C-reactive protein (CRP) level.[23,24,25] This study identified the risk factors following

examination and assessment, except for the CRP investigation, which does not need to be

examined because the increase in CRP can be associated with the presence of osteomyelitis

and inflammation[26] and can be detected by a thermograph. [20] Prevention strategies of ulcer

recurrence for patients with DM are multi-intervention. [27] Previous studies reported that an

integrated foot care program was the most preventive strategy for patients with DM.[28] The

frequency of foot care actions also varies from once a month to six instead of once. This

study does not use the term “integrated foot care” because it is still not a common

requirement in Indonesia, such as therapeutic footwear. In the IG, it has been recommended

to use appropriate footwear and custom footwear. Another study reported that there were no

significant differences in patients who received integrated foot care intervention with

standard care to reduce ulcer recurrence in the two groups. [27,28,29,30] Therefore, foot care needs

to be combined with other strategies. In conducting examinations and assessments on the foot

area in this study, one of the strategies was the use of a thermograph. This tool is excellent at

detecting an increase in skin temperature on the foot. Signs or symptoms of an increase in

temperature in the foot have warned the patient to be more alert and prevent the risk of ulcer.
[31]
Another preventive measure in foot care is the removal of callus and provision of skin

moisturizers on the feet. Callus removal and moisturizing the skin on the foot can prevent and

reduce the risk of ulcers.[32] This study reveals that education provided to patients with DM in

preventing ulcers may contribute to reducing recurrence rates. Furthermore, education for

patients with DM is an essential need because it can provide an understanding of their

condition and awareness of the patient on self-care management in an effort to prevent

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Prevention strategy of ulcer recurrence

complications, such as ulcers.(36) The strategy for preventing ulcer recurrence of patients

with DM should be an issue for the national government in its prevention efforts, specifically

in developing countries, such as Indonesia, which is an archipelagic country that requires

adequate support facilities and infrastructure and trained professional health workers to

prevent ulcer recurrence and further complications in patients with DM, such as the

establishment of a diabetic foot clinic in every community health center. The limitation of

this study are considering the proportion of the incidence of recurrence ulcers, the number of

samples in further studies needs to be increased while using the same sample size formulation

and methodology.

Conclusion

A prevention strategy in ulcer recurrence that nurses conduct in a home care setting can

significantly improve the quality of service with indicators reducing the incidence rate. This

study has brought new expectation for the area with limited resources to provide the best care

to patients with DM and reduce the incidence of foot ulcers. In implementing the prevention

program, a trained DM team is needed to provide knowledge and skills training to prevent

ulcers and recurrence in patients with DM. For all patients with DM who have recovered

from the ulcers, it is essential to take preventive measures by implementing the strategies in

the community setting. In care dimension, nurses responsible for early detection of any chang

es in skin and foot conditionn, foot care, and education program. This study postulated that

the evidence bases to support interventional strategies to prevent ulcer recurrence in patients

with DM already exist. Moreover, prevention of recurrent foot ulcers through integrated care

is effective.

Acknowledgements

We express our gratitude and appreciation to the staff who participated in this study.

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Prevention strategy of ulcer recurrence

Financial support and sponsorship

This study received financial support from the Faculty of Medicine, Tanjungpura University.

Conflicts of interest

Nothing to declare.

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Table 1a. Characteristics of participants between the two groups

Intervention Control
Characteristics

N (%) N (%)

Sex n

19
Prevention strategy of ulcer recurrence

Male 13(43.3) 13(43.3)

Female 17(56.7) 17(56.7)

Smoking

Yes 7 (23.3) 5 (16.7)

No 23 (76.7) 25 (83.3)

Neuropathy

Yes 23(76.7) 17(56.7)

No 7(23.3) 13(43.3)

Foot deformity

Yes 13(56.7) 19(63.3)

No 17(43.3) 11(36.7)

Ulcer recurrence

Yes 4 (13.3%) 10 (33.3%)

No 26 (86.7%) 20 (66.7%)

Duration of DM (years)

1–3 5 (16.7%) 7 (23.3%)

20
Prevention strategy of ulcer recurrence

3–6 6 (20.0%) 5 (16.7%)

6–9 4 (13.3%) 5 (16.7%)

>9 15 (50.0%) 13 (43.3%)

History of ulcer (times)

1 15 (50.0%) 16 (53.3%)

2 6 (20.0%) 4 (13.3%)

3 7 (23.3%) 7 (23.3%)

4 2 (6.7%) 3 (10.0%)

Length of ulcer recurrence

(months) from previous ulcer

<6 18 (60.0%) 23 (76.7%)

6–12 9 (30.0%) 3 (10.0%)

12–18 1 ( 3.3%) 2 ( 6.7%)

18–24 1 ( 3.3%) 2 ( 6.7%)

24–30 0( 0%) 0 ( 0%)

>30 1 ( 3.3%) 0 ( 0%)

Table 1b. Characteristics of participants between the two groups

21
Prevention strategy of ulcer recurrence

Variables Mean (SD) 95% confidence df t-test P

interval

Intervention Control Lower Upper

Age (years) 62 (10.46) 59.67 (11.48) −7.795 3.129 29 −0.874 0.389

ABI (number) 1.169 (0.24) 1.089 ( 0.19) −0.1897 0.0291 29 −1.052 0.144

HbA1C (%) 9.27 (2.13) 9.03 (2.73) −1.6870 1.2018 26 −0.345 0.733

SD : standard deviation

22

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