The Model and Efficacy of Online Nurse-led on the Clinical Outcome of Diabetic Foot Ulcers: A Systematic Review of Randomized Controlled Trials

Maria Komariah; Juan Alessandro Jeremis Maruli Nura Lele; Audrey Gunawan; Keyzha Amartya Adammayanti; Dewa Vighneswara; Karlos Berlusconi Sihaloho; Hesti Platini; Sidik Maulana; Shakira Amirah; Joue Abraham Trixie

doi:10.12688/f1000research.135373.1

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Systematic Review

The Model and Efficacy of Online Nurse-led on the Clinical Outcome of Diabetic Foot Ulcers: A Systematic Review of Randomized Controlled Trials

[version 1; peer review: 1 approved, 1 not approved]

Maria Komariah ¹, Juan Alessandro Jeremis Maruli Nura Lele², Audrey Gunawan², [...] Keyzha Amartya Adammayanti², Dewa Vighneswara², Karlos Berlusconi Sihaloho², Hesti Platini³, Sidik Maulana⁴, Shakira Amirah⁵, Joue Abraham Trixie⁶

Maria Komariah ¹, Juan Alessandro Jeremis Maruli Nura Lele², [...] Audrey Gunawan², Keyzha Amartya Adammayanti², Dewa Vighneswara², Karlos Berlusconi Sihaloho², Hesti Platini³, Sidik Maulana⁴, Shakira Amirah⁵, Joue Abraham Trixie⁶

PUBLISHED 23 Apr 2024

Author details Author details

¹ Department of Fundamental Nursing, Faculty of Nursing, Universitas Padjadjaran, Bandung, West Java, 45363, Indonesia
² Faculty of Medicine, Universitas Kristen Indonesia, East Jakarta, Special Capital Region of Jakarta, 13630, Indonesia
³ Department of Medical-Surgical Nursing, Faculty of Nursing, Universitas Padjadjaran, Bandung, West Java, 45363, Indonesia
⁴ Master of Nursing Program, Faculty of Nursing, Universitas Padjadjaran, Bandung, West Java, 45363, Indonesia
⁵ Faculty of Medicine, Universitas Indonesia, Depok, West Java, 10430, Indonesia
⁶ Faculty of Public Health, Universitas Indonesia, Depok, West Java, 10430, Indonesia

Maria Komariah
Roles: Conceptualization, Formal Analysis, Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

Juan Alessandro Jeremis Maruli Nura Lele
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Software, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Audrey Gunawan
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Keyzha Amartya Adammayanti
Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Dewa Vighneswara
Roles: Conceptualization, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Karlos Berlusconi Sihaloho
Roles: Methodology, Visualization, Writing – Review & Editing

Hesti Platini
Roles: Project Administration, Resources, Software, Supervision, Writing – Review & Editing

Sidik Maulana
Roles: Formal Analysis, Resources, Writing – Original Draft Preparation, Writing – Review & Editing

Shakira Amirah
Roles: Investigation, Methodology, Validation, Visualization

Joue Abraham Trixie
Roles: Conceptualization, Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background: The most frequent consequence for those with diabetes mellitus is diabetic foot ulcers. Diabetic ulcer treatment must be done properly and on time. The development of online-based intervention by nurses, such as messaging health, may improve the clinical outcome of diabetic foot ulcers by providing easier access, more convenience, and cost-effectiveness, especially for patients in rural areas.

Objective: This study aimed to perform a systematic review and meta-analysis the models and efficacy of online nurse-led intervention on clinical outcomes of diabetic foot ulcers.

Methods: Randomized Controlled Trials were searched by using PubMed, Scopus, and Google Scholar. The final inclusion study analyzed and synthesized by tabulation, clusterization, contextual and thematic approach, and assessed risk of bias by using RoB 2.0. The study used Mantel Haenszel method.

Results: Five randomized controlled trials with 1399 total number of participants were included. There are three studies with some concerns and two studies with low risk of bias. The nurse-led model for diabetic foot ulcer care consists of phone and web-based that conducted by nurse (community nurses and clinical nurses) and doctor specialists are involved in the service. The meta-analysis for amputation outcome showed that telehealth has more favor amputation number with RR 0.6 (95 % CI 0.43 - 0.84; p = 0.003). For healing wounds and mortality outcome, telehealth with RR 1.07 (95% CI 0.99 - 1.16; p = 0.11) and RR 1.37 (95 % CI 0.78 - 2.40; p =0.28), respectively.

Conclusions: Phone and web-based may improve clinical outcome of diabetic foot ulcers in terms of amputation outcome, but standard care still more favor in higher wound healing outcome and significantly lower mortality rate.

Keywords

diabetic foot ulcers, amputation outcome; healing wound; mortality outcome

Corresponding author: Maria Komariah

Competing interests: No competing interests were disclosed.

Grant information: This study was supported by Universitas Padjadjaran.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2024 Komariah M et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Komariah M, Lele JAJMN, Gunawan A et al. The Model and Efficacy of Online Nurse-led on the Clinical Outcome of Diabetic Foot Ulcers: A Systematic Review of Randomized Controlled Trials [version 1; peer review: 1 approved, 1 not approved]. F1000Research 2024, 13:375 (https://doi.org/10.12688/f1000research.135373.1) First published: 23 Apr 2024, 13:375 (https://doi.org/10.12688/f1000research.135373.1) Latest published: 23 Apr 2024, 13:375 (https://doi.org/10.12688/f1000research.135373.1)

Introduction

Diabetes mellitus is a chronic disease caused by unbalance of insulin production or sensitivity, and a higher level of blood glucose.¹ Complications caused by diabetes can affect the function of the heart and blood vessels, kidneys, nerves, and foot ulcers that occur in 40 to 60 million diabetic patients globally.² Diabetic ulcers are one of the most common complications experienced by diabetes mellitus.³ The increase in diabetes mellitus patients has an impact on increasing the incidence of diabetic ulcers because 15% of patients with diabetes mellitus have diabetic ulcers.⁴

The prevalence of diabetes is expected to increase from 9.3% (463 million) in 2019 to 10.2% (578 million) in 2030 and 10.9% (700 million) in 2045.⁵ Treatment of diabetic ulcers must be done correctly and on time. Inadequate treatment can lead to lower extremity amputation with approximately 85% incidence.⁴^,⁶ Standard care in the management of diabetic ulcers is usually through appointments with multiple health professionals depending on the severity. This can burden patients to get treatment.⁷ In areas where access to health care is challenging but has a good network, telehealth can be a solution. Telehealth is a health service that is accessed through telecommunication which is adapted from conventional practice. Telehealth can reduce potential healthcare disparities.⁸ Telehealth has a role in dealing with diabetic ulcers because long-distance treatment can provide easier access, more convenience, and cost-effectiveness, especially for patients in rural areas.⁷

M-Health is an interactive mobile health application developed for behavioral modification and well-being interventions.⁹ M-Health is designed for a specific health condition to summarize the healthcare interventions accurately and reliably.¹⁰ The use of m-Health in diabetes education, exercise tracking by a fitness tracker, manual dietary tracking, incorporating blood glucose readings, diabetes education, and communication with healthcare providers can reduce A1C by 0.3% in type 1 diabetes mellitus and 0.8% in type 2 diabetes mellitus after 12 months of m-Health intervention when compared with the standard care.¹¹ Research is growing with the delivery of health care remotely via an application on a mobile device (called mobile health or m-Health). Mobile phones are ubiquitous in society, and several software platforms, especially web-based and software applications, have been developed for diabetes self-management. Besides, m-health is improving the outcome of care, and the role of nurses is also important in integrating the foot ulcer care model. There has been a previous meta-analysis of telehealth for diabetic foot ulcer care.¹² However, included studies of study just only three RCTs studies and does not discuss the related models of online-based intervention for foot ulcer care. In this regard, the study focused to perform a systematic review and meta-analysis of the effect of telehealth on clinical outcomes of diabetic foot ulcers.

Therefore, the aim of telehealth interventions across the diabetic foot ulcer care continuum is to assess the efficacy of telehealth-based technologies that can substantially modify DFU risk factors such as screening and identifying loss of protective sensation, monitoring for lesions, palpation, and auscultation in individuals with DM foot during follow-up appointments so as to develop lower limb amputation prevention strategies, improve patient quality of life and reduce economic burden.¹²^–¹⁴ Here, we conducted a systematic review and meta-analysis of all available studies to assess the efficacy of telehealth in diabetic foot ulcers.

Nurses play an important role in preventing and controlling diabetic foot ulcers (DFU) across the continuum of care. As a result, they can modify DFU risk factors such as screening and identifying loss of protective sensation, monitoring the presence of a lesion, palpation, and auscultation in individuals with DM foot during follow-up appointments.¹²^,¹³ By educational initiatives, risk assessment, and diabetes foot care, nurses’ knowledge of DFU is crucial in preventing foot ulcers and lower limb amputations. It has been found that nurses who were knowledgeable and had a pleasant attitude were more likely to participate in ulcer care.¹³^,¹⁴

Methods

Literature search

PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement rules were used to conduct a systematic review.¹⁵^,³⁵ Searches for included studies were conducted on databases including PubMed, Cochrane, and Google Scholar. We conducted a search using the terms (diabetic foot ulcer OR diabetes) AND (web OR phone OR telemedicine) AND (clinical outcome OR amputation OR healing OR mortality. The details of the search strategy can be seen in the Extended data.³⁵

Eligibility criteria

The eligibility criteria for inclusion and exclusion in this review were established based on the PICO (Population, Intervention, Comparison, and Outcome) framework. The population of interest consisted of patients with diabetic foot ulcers diagnosed based on clinical presentation, physical examination, and other diagnostic tests such as X-ray, MRI, or biopsy. The interventions included were randomized controlled trials that examined the effects of online nurse-led interventions on the clinical outcomes of diabetic foot ulcers. The comparison intervention was standard or usual care, which is care that is provided solely through face-to-face interaction and not through telehealth. The eligible studies assessed clinical outcomes such as wound healing, amputation, and mortality rate through validated clinical and laboratory measures. The outcomes were assessed by trained healthcare professionals who were blinded to the intervention allocation. Moreover, the exclusion criteria include articles that have not undergone peer review, were published before 2010 for relevantion, articles that were not in English, and were not randomized controlled trial (RCT).

Data extraction

The main results to show the efficacy of phone and web-based telehealth for clinical outcomes of patients with diabetic foot ulcers were amputation, healing wounds, and mortality. The results were analyzed and synthesized through a qualitative approach in the form of tabulation, clusterization, thematic analysis, and contextual descriptions. The data items that will be visualized including author and year, mean or median of age, study design, country of the study, participant characteristics, number of participants, type of telehealth, and outcome data.

Statistical analysis

Meta-analysis was performed by using the Review Manager 5.4 statistical package (Cochrane Collaboration, Oxford, UK). The clinical outcome of the dichotomous data was reported as a risk ratio (RR), and an appropriate 95% confidence interval (95% CI) was calculated. Pooled effect estimates were generated using the Mantel-Haenszel method formula in the form of a risk ratio (RR) with their corresponding 95% confidence intervals (CI). The inconsistency index (I2) and subgroup analysis using the Chi-square test were utilized to explore potential sources of heterogeneity. A p-value of less than 0.05 and an I2 of more than 50% were considered significant for heterogeneity. To account for interstudy variability, a random-effects model was utilized regardless of the heterogeneity in the studies. We considered a two-tailed p-value with statistical significance set at p ≤ 0.05.

Risk of bias assessment

The Revised Instrument for Risk of Bias in Randomized Trials (RoB 2.0), which has five domains for initiative studies, was used to assess the risk of bias in the final inclusion studies. The authors used the Cochrane algorithm to assess risk of bias. The results are then added to the domain file bias (.xlsx). The file will then be uploaded to his ROBVIS website and the output data will be displayed properly.

Results

Selection process

Based on the results of the article search in the main sources (PubMed, ScienceDirect, and Google Scholar), 632 articles were identified. Of these, nine of them are duplicate studies. Thirty-eight studies were excluded at the screening stage because they were grey literatures. Nine studies didn’t have the same context as PICO that has been proposed. In detail, four studies did not have the same population, one study had different interventions, two different comparison studies, and two had different primary and secondary outcomes (see Figure 1).

Figure 1. PRISMA flow diagram.

There were five final articles that matched the inclusion or eligibility criteria with 1399 total participants. Four final inclusion studies were classified as having blinding techniques and one study with open-label techniques.¹⁶^–¹⁹ The types of online nurse-led interventions used were telephone and web-based. The participants involved were diabetic patients with complications of diabetic foot ulcers.

Characteristics of included studies

The included studies were all randomized controlled trials (RCTs). These studies were conducted in five different countries, including Norway (2), Denmark (2), and Australia (1), with a total of 1094 patients diagnosed with diabetes foot ulcers. The interventions used in the studies included an interactive web-based ulcer record and a mobile phone in two of the studies, a mobile phone in two other studies, and a software-based system in one study. The interventions were all online nurse-led, with the aim of improving the clinical outcomes of patients with diabetic foot ulcers (see Table 1).

Table 1. Characteristic of included studies.

Study	Design Study	Country	Participant			Type of Telehealth
Study	Design Study	Country	Characteristics	Age	Sample size	Type of Telehealth
Iversen et al. (2020)¹⁷	RCT	Norway	Patients with type 1 or type 2 diabetes who are 20 years of age or older are diagnosed with a new DFU.	65.5	156	Interactive web-based ulcer record and a mobile phone
Smith-Strøm et al. (2018)¹⁹	RCT Unblind	Norway	Patients with DM 1 and 2, at least had DM at the age of 20 years. already suffered from foot ulcers for at least the previous 6 months will be excluded.	66.4	182	Interactive web-based ulcer record and a mobile phone
Fasterholdt et al. (2018)¹⁶	RCT	Denmark	Patients diagnosed with diabetic foot ulcers initiating treatment at one of the specialized ulcer outpatient clinics were eligible for the clinical study.	60.9	374	Mobile phone
Rasmussen et al. (2015)¹⁸	RCT	Denmark	Individuals with diabetic foot ulcers.	72	374	Mobile phone
Manuel (2012)²⁰	Pilot RCT	Australia	Patients with diabetic foot ulcer	70.3	8	Software-based system

The nursing care model of online nurse-led of diabetic foot ulcer care

The online nurse-led model utilizes both a mobile application and a web-based application. It involves community nurses and clinical nurses, as well as specialist doctors. Table 2 and Figure 2 show the model of an integrated online nurse-led foot ulcer care system. The diagram illustrates that nursing activities are conducted through online interventions by a community nurse who performs assessments and interventions. The assessment results are reported by community nurses via the web, and the planning is carried out in interprofessional collaboration involving specialist nurses and doctors. Specialist nurses review the results and provide feedback that can be discussed through a mobile phone or email. Additionally, specialist nurses conduct home visits at least once a week. This model enables integrated care across different health sector levels and has the potential to be implemented in rural areas.

Table 2. Model of online-led diabetic foot ulcer care.

Study	Type	Input	Process	Output
Rasmusen et al. (2015)¹⁸	Nurse-led telephone	Community nurse conducted a home visit and assess patients’ ulcers. The nurse also uploaded ulcer images and report detail assessment through an online database	The ulcer image will be evaluated and a community nurse can be consulted their patient with a nurse specialist and physician.	Community nurses provide daily ulcer care by a nurse who specialized in wound/ulcer care.
Smith-Strøm et al. (2018)¹⁹	Mobile phone and web-based application	Community nurse written assessment and send ulcer images via mobile phone.	Assessment by a community nurse and ulcer image sent through web-based ulcer record for further assessment.	Nurse specialists provide feedback and additional follow-up procedures. Community nurse and nurse specialist further discussion regarding feedback by phone or email.
Iversen et al. (2020)¹⁷	Mobile phone and web-based application	Community nurse taking ulcer pictures and writing assessment	The pictures and assessments send web-based from a mobile phone or computer via the internet. This health system enables integration across the health sector level.	A specialist reviews the ulcer picture, facilitates counseling, and facilitates feedback.
Fasterholdt et al. (2018)¹⁶	Mobile phone	Community nurse written assessment and send ulcer image through an online database.	The ulcer image will be evaluated and community nurses can consult the condition of their patients to specialist nurses and physician.	Community nurses provide standard daily ulcer care under the supervision of a nurse who specialized in wound care.
Manuel (2012)²⁰	Software-based system	The wounds of the study subjects were photographed using a digital camera after the podiatrist had evaluated the participants. The ulcer was examined by using the AMWIS program in conjunction with the documented procedures.	The picture was forwarded to a wound consultant working in the Podiatry Department of Fremantle Hospital. When determining how to properly treat the wound, the wound consultant's recommendations were taken into account.	Both the local nurse team and the podiatrist were responsible for applying the dressings. The podiatrist was responsible for the design and implementation of offloading devices as well as the wound debridement process.

Figure 2. Online nurse-lead integration of foot ulcer care model.

The effect of online nurse-led intervention usage on clinical outcomes

Within five final inclusion studies, there was just data from Rasmussen et al. (2015)¹⁸ in mortality and Manuel (2012)²⁰ in healing outcome statistically significant with p = 0.0001, respectively (Table 3).

Table 3. Outcome of included studies.

Outcome	Study	Risk ratio	p-value
Healing	Iversen et al. (2020)¹⁷	1.37	0.43
	Smith-Strøm et al. (2018)¹⁹	1.16	1.59
	Rasmussen et al. (2015)¹⁸	1.11	0.42
	Rasmussen et al. (2015)¹⁸	Pre-M, SD (18.12 ± 18.07)	Pre-M, SD (28.80 ± 21.01)
Amputation	Iversen et al. (2020)¹⁷	0.36	0.07
	Smith-Strøm et al. (2018)¹⁹	0.43	0.07
	Fasterholdt et al. (2018)¹⁶	0.79	0.39
	Rasmussen et al. (2015)¹⁸	0.87	0.59
Mortality	Iversen et al. (2020)¹⁷	0.80	0.73
	Smith-Strøm et al. (2018)¹⁹	0.94	0.91
	Rasmussen et al. (2015)¹⁸	8.68	0.0001*

* Significant.

In this study, we recommend interactive telehealth. Interactive telehealth makes the relationship between doctors and patients better through two-way communication.¹⁸ Where doctors do not need to meet in real time but respond to the transmission of information from patients in real time. Meanwhile, non-interactive telehealth is the opposite. Patients act more passively and nurses and doctors are more active. Thus, interactive telehealth is much more recommended because there is better communication between doctors and patients.¹⁹

The effect of online nurse-led intervention usage on amputation

All five studies were included in the amputation analysis, four studies in healing wounds, and five studies in mortality analysis. The meta-analysis for amputation outcomes showed that the online nurse-led intervention group has a higher number of events with a Risk Ratio (RR) of 0.66 (p = 0.01; 95% CI 0.47-0.92). A funnel plot is a graphical representation of individual studies precision and effect size in a meta-analysis (see Figure 3). In a meta-analysis investigating the effectiveness of telemedicine treatments for amputation outcomes. The distribution of studies in the funnel plot appears homogenous, suggesting that there is little or no publication bias and the studies are similar in terms of their precision and effect size. This indicates that the studies are comparable and the results of the meta-analysis are robust. A homogenous funnel plot also suggests that the overall estimate of treatment effect is likely to be reliable (see Figure 4).

Figure 3. The effect of online nurse-led intervention usage on amputation outcome of diabetic foot ulcer patients.

Figure 4. Funnel plot of online nurse-led intervention usage on amputation outcome of diabetic foot ulcer patients.

The effect of online nurse-led intervention usage on healing

The Mantel-Haenszel analysis for healing wound outcome showed that standard care has more favor than the online nurse-led intervention group with RR 1.02 (p = 0.61; 95% CI 0.94-1.11). A funnel plot is a graphical representation of individual studies’ precision and effect size in a meta-analysis (see Figure 5). In a meta-analysis investigating the effectiveness of telemedicine treatments for DFU. The distribution of studies in the funnel plot appears homogeneous, if the plot is symmetrical, such as an inverted V, this is interpreted as indicating that there may be no publication bias. If the plot is asymmetric, the interpretation is likely to be publication bias. In this funnel plot, the data is shown to be homogeneous indicating that the overall estimate of the treatment effect tends to be reliable (see Figure 6).

Figure 5. The effect of online nurse-led intervention usage on wound healing outcome of diabetic foot ulcer patients.

Figure 6. Funnel plot of online nurse-led intervention usage on mortality outcome of diabetic foot ulcer patients.

The effect of online nurse-led intervention usage on mortality

The Mantel-Haenszel analysis for mortality outcome showed that standard care is not statistically significant. Standard care group with RR 1.48 (p = 0.30; 95% CI 0.70-3.12). nurse-led care group these data indicate that standard care usage is more recommended for reducing the mortality rate (see Figure 7). The distribution of studies in the funnel plot may appear heterogeneous, but there may be one study, Rasmussen et al. (2015), that appears as an outlier (see Figure 8). This outlier study may have reported a substantially larger effect size or a smaller standard error compared to the other studies in the meta-analysis.

Figure 7. The effect of online nurse-led intervention usage on wound healing outcome of diabetic foot ulcer patients.

Figure 8. Funnel plot of online nurse-led intervention usage on wound healing outcome of diabetic foot ulcer patients.

Risk of bias

There are two studies with a low risk of bias, three studies with some concern, and zero research with a high risk of bias, according to the risk of bias assessment performed using RoB 2.0. D5 dominated the bias risk domain with some level of concern (bias in the selection of the reported result). Whereas D1 (bias occurring in the randomization process), D3 (bias due to missing outcome data), and D4 (bias due to incomplete outcome data) dominated the risk of bias domain with a low-risk level (bias in the measurement of the outcome) (see Figure 9 and Figure 10).

Figure 9. Traffic light plot.

Figure 10. Summary risk of bias.

Discussion

Chronic foot ulcers are a common complication of diabetes. These boils can last for months or even years. They can have a significant negative impact on an individual’s quality of life, are expensive to treat, and can lead to amputation of the affected limb.²¹ Treatment of diabetic ulcers must be carried out correctly and promptly. Inadequate treatment can lead to lower extremity amputation.⁴^,⁶ Standard care in the management of diabetic ulcers is usually through appointments with several health professionals depending on the severity.²² The long-distance that is often traveled is the reason, and the slow follow-up is the main factor for the situation to worsen and can burden the patient to get treatment.²³

Mobile health (m-Health) uses mobile technology to provide monitoring and interaction across multiple functions. Through this technology, patients can be more involved in their diabetes management, improve their diet, achieve better glycemic control, lose weight, and achieve better health outcomes while maintaining constant patient-provider communication.¹¹ When compared to standard care, m-health is more efficient in remote care, providing more accessible, more convenient, and cost-effective access, especially for patients in rural areas.⁷ Telehealth can be a solution to improving health services, including the treatment and prevention of diseases.²⁴^,²⁵ This service can improve health services in Indonesia, especially in areas with difficult access to health services.

In research conducted by Farmer, Blood glucose values were manually entered, and motivational messages (unrelated to blood glucose levels) were automatically sent to the phone via SMS by a server. The telehealth system offers a platform with the benefit of basing management on real-time data transfer, shared information between clinicians and patients, and the ability for quick data analysis to provide advanced decision assistance, in comparison to other systems.²⁶ Online telehealth web-based technology can help avoid crowds in a pandemic situation. In one study, Huurne et al. conducted research on web-based technologies to improve healthcare services for individuals with chronic eating disorders. In the study he used a web-based treatment program to improve health care services, 54% of participants completed all tasks and programs to significantly improve BMI, physical, mental health, and quality of life.²⁷^,²⁸

The current review showed that phone and web-based telehealth have has no better effect on wound healing than standard care. This is contradictory to research conducted by Stern et al., where the probability of healing for the control period was estimated to be 35.0%, and for the intervention, period to be 53.4%.²⁹ This difference is not statistically significant as the two confidence intervals overlap. However, in a study conducted by Santamaria et al., intervention group patients had a positive healing rate of 6.82% per week. In contrast, controls had a negative rate of -4.90% per week (p = 0.012).³⁰ The data has also shown the same indication for amputation outcomes. A meta-analysis conducted by Yammine K and Estephan M in 2021 showed the same result as our discussion (p = 0.003, RR 0.6). Telehealth services were proven to prevent amputation (p = 0.007, OR = 0.48), but not with wound healing rate (p = 0.4, OR = 1.35) and mortality (p = 0.2, OR = 1.66).³¹ However the study by Chumbler showed there was longer survival for the intervention group (telehealth) versus the control group (mean survival time 1348 vs 1278 days; p = 0.015). A multivariate analysis indicated that the telemonitoring program was associated with reduced 4-year all-cause mortality (p = 0.013, HR = 0.7, 95% CI 0.5–0.9). This data is contradictory to our result.³²

Telehealth is generally regarded favorably by both patients and clinicians, particularly as an adjunct to face-to-face care.⁷^,⁸ Digital imaging, one of the m-Health facilities, has similar reliability to live assessment for assessing ulcers.⁷ The existence of technological developments allows telehealth to continue to implement health services according to the community’s needs by increasing the advances of the designed applications.³³ Areas, where there is still a shortage of medical personnel, can apply telehealth services for diabetic wound control.

The findings of our integrative systematic review and meta-analysis have significant implications for practice in nursing and other healthcare professions, particularly in the management of diabetic foot ulcers. Our study highlights the potential benefits of online nurse-led interventions in improving the clinical outcomes of patients with diabetic foot ulcers. This model can be easily accessible, cost-effective, and can provide support to patients in remote or underserved areas.

The implication for nursing practice is significant, as it emphasizes the need for nurse-led interventions to be incorporated into the care plan of patients with diabetic foot ulcers. This can improve patient satisfaction, enhance patient education, and improve the quality of care provided. Furthermore, the online platform provides opportunities for nurses to practice in a more autonomous and innovative manner, resulting in better job satisfaction and improved professional development.

The study findings also have implications for other healthcare professions such as podiatry, wound care, and endocrinology. The integration of online nurse-led interventions can complement and enhance the care provided by other healthcare professionals, resulting in improved patient outcomes. It also highlights the need for multidisciplinary collaboration in the management of diabetic foot ulcers. Platini et al, also mentioned that telecoaching has the potential to enhance clinical and self-care outcomes for people with diabetes mellitus during COVID-19 and similar pandemics.³⁴

The local government needs to conduct a more in-depth study of telehealth services and the local health office. Only patients with controlled diabetic ulcers can apply wound control through telehealth services. Thus, the patient does not need to come to a health facility just for control. However, if the wound has not been controlled, the patient still needs to visit a health facility. In addition to proposing telehealth services, the government still has to improve health service facilities in the regions.

This study has several limitations points: there was a potential heterogeneity caused by difference follow-up times in each study, the difficulty in finding several similar articles, and none of the studies discussed pharmacological therapy and lifestyle interventions. In addition, the heterogeneity in mortality outcomes was high.

Conclusion

Phone and web-based telehealth can reduce the amputation rate of diabetic foot ulcers, but it has no better effect on wound healing and mortality rate than standard care. However, there are still debate about the method of telehealth usage, in-appropriate guideline for its usage, and real-time interaction needed. In the case of diabetic ulcer foot, the author would recommend interactive telehealth usage for a better outcome.

Data availability

Underlying data

All data underlying the results are available as part of the article and no additional source data are required.

Extended data

Zenodo: The model and efficacy of online nurse-led on the clinical outcome of diabetic foot ulcers: an integrative systematic review and meta-analysis of randomized controlled trials. https://zenodo.org/record/8309776.³⁵

This project contains the following extended data:

- Appendix.docx (search strategy)
- Extraction data telemedicine for diabetic foot ulcers.xlsx

Reporting guidelines

Zenodo: PRISMA checklist for ‘The model and efficacy of online nurse-led care on the clinical outcome of diabetic foot ulcers: an integrative systematic review and meta-analysis of randomized controlled trials’. https://zenodo.org/record/8309776.³⁵

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Acknowledgments

The authors appreciated Universitas Padjadjaran, Bandung, West Java, Indonesia, for facilitating the database search to this scoping review.

The abstract for this study has been published in the Padjadjaran International Nursing Conference Book of Abstracts (http://pinc.fkep.unpad.ac.id/Book_of_Abstract.pdf).

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