Evidence-Based Medicine

Research Appraisals

Evidence-based critical appraisals of the latest medical research, systematically evaluated using Oxford CEBM methodology.

Showing 7 appraisals

otherEvidence: Weak
70CEBM

Advances in skin & wound care

Mobile Health App Needs Among Patients With Diabetic Foot Ulcers in China: A Qualitative Study From the Perceptions of Patients, Caregivers, and Health Care Professionals

OBJECTIVE: To explore the specific needs of patients with diabetic foot ulcers (DFUs), caregivers, and health care professionals (HCPs) for a mobile health (mHealth) app, aiming to inform the design and development of effective mHealth service solutions. METHODS: This descriptive qualitative study was conducted from June to September 2024 in the wound care clinics of 2 local hospitals. Participants included patients with DFUs, caregivers, and HCPs directly involved in their care. Interview data were analyzed, synthesized, and refined using content analysis. RESULTS: Five key themes emerged: the pressing need to implement mHealth app services, convenient and personalized access to information, continuous and specialized health guidance, a multidisciplinary approach to disease management, and free access alongside privacy and legal protections. CONCLUSIONS: This study provides valuable insights for the design and development of an mHealth app for DFU. During the development process, it is essential to consider user needs and ensure the app meets the expectations of patients and related groups for personalized, continuous, and specialized health guidance; free access; privacy protection; and multidisciplinary collaboration. A balance should be struck between convenience and security of the app's features, to encourage user engagement and enhance the app's value and effectiveness.

2 July 2026

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qualitativeEvidence: Moderate
80CEBM

JMIR formative research

Self-Monitoring Risk Factors for Diabetic Foot Ulceration With the Feetchecker App: Mixed Methods Study

BACKGROUND: A prevalent and serious complication of diabetes mellitus is the development of diabetic foot ulcer (DFU). There is a need for effective solutions that help prevent DFU to support our increasingly stressed health care systems. The use of mobile health (mHealth) tools has been shown to improve awareness and effective self-care management skills in people at risk of developing diabetic foot ulceration. OBJECTIVE: In this study, we aimed to investigate the perceived usefulness, engagement, and overall user experience of the Feetchecker app, a self-monitoring mHealth app for people at risk of DFU. METHODS: A total of 24 patients (mean age 71, SD 8.6 years) with type 2 diabetes mellitus at risk of developing diabetic foot ulceration completed a 3-month evaluation period (70 recruited, 36 included, 12 dropped out) of a self-monitoring mobile app called Feetchecker app. A mixed methods approach was used to combine insights from app data with qualitative data from a pre- and postsurvey as well as interviews with patients and involved podiatrists. Data were analyzed using descriptive statistics and thematic analysis. We evaluated overall use of the app, patient engagement, and user experiences. RESULTS: Patients who fully completed the study conducted 393 feetchecks. In total, 7 patients sent in 9 pictures; all 7 were called for follow-up by a podiatrist. Overall, patients had a positive experience with the app and perceived the Feetchecker app as a valuable tool to monitor their feet for potential risk factors of DFU. Ease of use in performing a feetcheck and sending the podiatrist a picture was described as an important feature. Three main types of engagement with the Feetchecker app emerged: continuous, frequent, and no to little engagement. These patterns highlight enablers for self-monitoring such as ease-of-use, easy access to a podiatrist, and social support, as well as barriers such as digital skills and sustained engagement. Podiatrists highlighted the benefits of having patients report potential issues quicker and the ability to monitor their patients remotely. Challenges remain in integrating the promotion of the Feetchecker app into their consultations. CONCLUSIONS: The Feetchecker app supported patients in self-monitoring risk factors associated with DFU through routine checks and quick contact with a health care professional in case of a potential issue. Overall, patients described a positive user experience and considered the app helpful. While mHealth tools are not for everyone, user engagement for many patients was high and shows that such apps can offer support for people able to use them. Future research should focus on improving usability and engagement with the app as well as extend the way patients can communicate with health care professionals beyond a picture.

29 May 2026

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Systematic ReviewEvidence: Weak
60CEBM

Medwave

Effects of manual therapy on pain and function in patients with plantar fasciitis: A systematic review of the literature

OBJECTIVE: Plantar fasciitis is common and impairs people's ability to move. Manual therapy is frequently used to treat plantar fasciitis. However, its effects are inconclusive. For this reason, the purpose of this systematic review is to determine the effect of manual therapy on plantar fasciitis. METHODS: A systematic review of the literature was conducted, following the PRISMA checklist. Five databases (CINAHL, Scopus, PubMed, Web of Science, and OVID) were searched, along with a review of the gray literature and a manual search. Randomized clinical trials from 2014 to 2024 were selected that examined the efficacy of manual therapy in reducing pain intensity and improving function in patients aged 18 to 60 years with a clinical diagnosis of plantar fasciitis. Methodological quality (PEDro scale) and risk of bias (risk of bias scale) were assessed. RESULTS: Four randomized clinical trials (n = 224) were included, reporting controversial statistical differences in pain and function. In addition, two studies reported clinically relevant changes favoring manual therapy. PEDro scale scores ranged from 4 to 6, and three studies presented a high risk of bias. CONCLUSIONS: The effects of manual therapy on pain and function in patients with plantar fasciitis are uncertain. The evidence is limited, heterogeneous, and lacking in methodological rigor. A larger number of randomized clinical trials with more consistent, replicable protocols are needed to determine the contributions of manual therapy to improving pain and function in patients with plantar fasciitis. Similarly, the inconsistency and limited evidence on indicators of clinical significance in the selected studies preclude an assessment of the clinical impact of this intervention. PROSPERO REGISTRATION: CRD42024501550. OBJETIVO: La fascitis plantar es común y genera alteraciones en la capacidad de moverse de las personas. La terapia manual se aplica frecuentemente en la fascitis plantar. Sin embargo, sus efectos no son concluyentes. Por esta razón, el propósito de esta revisión sistemática es determinar del efecto de la terapia manual sobre la fascitis plantar. MÉTODOS: Se realizó una revisión sistemática de la literatura, considerando la lista de verificación de PRISMA. Se consultaron cinco bases de datos (CINAHL, Scopus, PubMed, y OVID) junto con consulta de la literatura gris y búsqueda manual. Se seleccionaron ensayos clínicos aleatorios de 2014 a 2024 que consideraron la eficacia de la terapia manual en el cambio de la intensidad del dolor y funcionalidad en pacientes con diagnóstico clínico de fascitis plantar entre 18 y 60 años. Se determinó la calidad metodológica (escala PEDro) y riesgo de sesgo (escala riesgo de sesgo). RESULTADOS: Se incluyeron cuatro ensayos clínicos aleatorizados (n = 224), que reportaron diferencias estadísticas controversiales para dolor y la funcionalidad. Además, dos estudios reportaron cambios clínicamente relevantes a favor de la terapia manual. Los puntajes de la escala PEDro variaron de 4 a 6, y tres estudios presentaron alto riesgo de sesgo. CONCLUSIONES: Los efectos de la terapia manual sobre el dolor y la funcionalidad en pacientes con fascitis plantar son inciertos. La evidencia es limitada, heterogénea y con bajo rigor metodológico. Es necesario un mayor número de ensayos clínicos aleatorizados, con protocolos más consistentes y replicables para concluir definitivamente sobre los aportes de la terapia manual en los efectos clínicos en el dolor y funcionalidad de pacientes con fascitis plantar. De igual forma, la inconsistencia y limitada evidencia de indicadores de significancia clínica en los estudios seleccionados, no permite evaluar el impacto clínico de esta intervención. REGISTRO DEL PROTOCOLO: PROSPERO CRD42024501550.

23 May 2026

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Systematic ReviewEvidence: Moderate
65CEBM

BMJ open diabetes research & care

Topical therapies for diabetic foot ulcers: a systematic review and network meta-analysis

OBJECTIVE: Diabetic foot ulcer (DFU) is a life-threatening complication associated with high amputation and mortality rates. While numerous topical therapies exist, their comparative efficacy and safety remain unclear. We aimed to compare the efficacy and safety of topical therapies for DFUs to identify optimal treatment strategies. RESEARCH DESIGN AND METHODS: We searched PubMed, Embase, and CENTRAL from inception to February 1, 2025, for randomized clinical trials (RCTs) evaluating topical therapies for DFUs. We excluded non-topical interventions to ensure clinically relevant comparisons. A Bayesian network meta-analysis was performed. The primary outcome was wound healing rate. RESULTS: We included 51 RCTs involving 6161 patients and 23 interventions. 12 topical therapies, including placenta-derived products, platelet-related products, ON101, epidermal growth factor, and tissue-engineered skin substitutes, significantly improved wound healing rates vs standard of care (SOC). Placenta-derived products showed the greatest efficacy (OR 7.85 (95% credible interval (CrI) 4.62 to 14.15)) and were the only intervention to significantly reduce adverse events vs SOC (0.25 (95% CrI 0.10 to 0.60)). No interventions differed significantly from SOC in time to wound healing, serious adverse events, or infections. CONCLUSIONS: Placenta-derived products and other biological or advanced topical therapies may demonstrate greater efficacy than the SOC in facilitating the healing of DFUs. Nevertheless, the certainty of evidence for most comparisons remains in the low-to-moderate range. These findings suggest potential benefits in integrating these therapies into the management of DFUs. However, high-quality RCTs are necessary to verify long-term outcomes.

23 May 2026

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otherEvidence: Weak
55CEBM

Journal of diabetes science and technology

Adherence Monitor for Measurement of Removable Cast Walker Wear-Time: Multiple Sensors and Predictive Analytics Improve Accuracy

BACKGROUND: Treatment of diabetes and its complications is a primary health care expense. Up to 25% of people with diabetes will develop diabetic foot ulcers (DFUs). Removable cast walker (RCW) boots commonly prescribed for DFU treatment, promote healing, and provide offloading and wound protection. Patient RCW removal for hygiene and wound care can lead to decreased adherence and treatment effectiveness. This study evaluated a new system for wear-time adherence measurement using multiple sensor types. METHODS: An electronic wear-time monitor was developed, which included internal and external temperature sensors, an accelerometer, and capacitive proximity foot and ankle sensors. Time-stamped and date-stamped data were saved once per minute for up to 22 days. Ten healthy volunteer subjects were recruited to wear an RCW for two weeks while keeping a diary of don/doff times. Sensor data were then compared with volunteers' wear diaries using confusion matrix predictive analytics. RESULTS: Algorithms were developed for data processing. Correlation coefficients between algorithms and diaries were calculated for individual and multiple sensor combinations. Differential temperature and accelerometer algorithms were significantly better at predicting subject wear-time than individual temperature sensor algorithms (P = .009, P = .001, respectively). Foot proximity had significantly better correlation with subject diaries than temperature (P = .024), and acceleration algorithms (P = .005). Multi-sensor analysis showed high correlation (.96) with wear-time from subject diaries. CONCLUSIONS: Removable cast walker wear-time can be accurately determined using an electronic data recorder and multiple sensors. Wear-time measurement accuracy can be improved using algorithms that operate on data from multiple sensors that use a variety of sensor technologies.

9 May 2026

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diagnosticEvidence: Moderate
70CEBM

Journal of diabetes science and technology

Plantar Thermogram Analysis Using Deep Learning for Diabetic Foot Risk Classification

AIMS: Thermography is a noninvasive method to identify patients at risk of diabetic foot ulcers. In this study, we employed thermography and deep learning to stratify patients with diabetes at risk of developing foot ulcers. METHODS: We prospectively recorded clinical data and plantar thermograms for adult patients with diabetes who underwent diabetic foot screening. A total of 153 thermal images were analyzed using a deep learning algorithm to determine the risk of diabetic foot ulcers. The neural network was trained using a balanced dataset consisting of 98 thermal images (49 normal and 49 abnormal), with 80% allocated for training and 20% for validation. The trained model was then validated on a separate testing dataset consisting of 55 thermal images (42 normal and 13 abnormal). The neural network was trained to prioritize higher sensitivity in identifying at-risk feet for screening purposes. RESULTS: Participants had a mean age of 63.1 ± 12.6 years (52.3% female), and 62.1% had been diagnosed with diabetes for more than 10 years. The average body mass index was 27.5 ± 5.6 kg/m2. Of the thermal images, 91 were classified as category 0 and 62 as categories 1 to 3, according to the diabetic foot risk classification system of the International Working Group on the Diabetic Foot. Using five-fold cross-validation, the neural network model achieved an overall accuracy of 71.8 ± 4.9%, a sensitivity of 81.2 ± 10.0%, and a specificity of 64.0 ± 7.4%. Additionally, the Matthews correlation coefficient was 0.46 ± 0.08%Conclusions:These results suggest that thermography combined with deep learning could be developed for screening purposes to stratify patients at risk of developing diabetic foot ulcers.

4 May 2026

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Systematic ReviewEvidence: Weak
60CEBM

PloS one

Advanced microfluidic and 3D cell culture platforms for modeling vascularization in diabetic foot ulcers: A systematic review of translational challenges and perspectives

The healing process of diabetic foot ulcers (DFUs) presents a slow pattern with an increased risk of infections, ischemia, and thrombosis correlated with high levels of reactive oxygen species production. Vascular injury is one of the factors contributing to the difficulty of wound healing in diabetic patients. Although the understanding of the pathophysiology of DFUs has significantly increased in recent years, associated treatments still have a high level of failure, leading to high morbidity rates, mortality, and amputations. Three-dimensional (3D) cell culture platforms offer a new approach to investigating and treating these wounds, as they can reproduce one or more physiological systems in a relevant microenvironment. This systematic review describes the advancements, challenges, and future implications of advanced 3D culture models in vascularization, encompassing pathophysiological understanding, treatment, and prognostic perspectives. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. This work was registered under PROSPERO protocol number CRD42022336473. The eligibility criteria addressed studies related to chronic DFUs that analyzed vascularization during the healing process. The selected study designs involved 3D cultures and organ-on-a- chip (OoC) platforms, utilizing either primary or secondary human cell lines. Studies published more than 10 years ago or using only animal cells in 2D culture environments were excluded. The search was conducted in PubMed, LILACS, Embase, MEDLINE, IEEE, the BSV regional portal, ScienceDirect, Scopus, CINAHL, EBSCO, and Web of Science. A total of 2,539 relevant studies were identified as of June 1, 2025. After screening, only seven met the inclusion criteria. These studies reflect a growing interest in using hydrogel scaffolds and microfluidic systems to replicate diabetic skin environments; however, the field remains in an early stage of development. OoC platforms, in particular, stand out for their ability to recreate dynamic, tissue-like conditions and vascular function. While some promising attempts have been made to combine hydrogels with these technologies, the evidence is still limited and inconclusive for chronic wound modeling. This review underscores both the potential and the urgent need for more robust and translational research in this area-especially toward building personalized, clinically relevant models to support future drug testing and therapeutic innovation.

7 Apr 2026

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