Clinical performance and quality of life impact of an absorbent bacteria-binding foam dressing.

The aim of this prospective multicentre observational study was to assess the clinical performance and safety of Cutimed® Siltec® Sorbact® absorbent bacteria-binding foam dressing in wound healing and its impact on patients' quality of life (QoL). The study was conducted under routine clinical conditions in 5 study sites in Germany and Poland. Each patient with a venous leg ulcer (VLU) or a diabetic foot ulcer (DFU) was observed for 28 days (initial visit and close-out visit, as well as 3 control visits). An assessment of QoL of the patient was undertaken before and after the study. Sixty-two patients were included in the statistical analysis. Clinicians rated the following assessment parameters in relation to Cutimed Siltec Sorbact dressings as 'very good' to 'good': wearing comfort (rated by the patient), application and removal, exudate absorption with or without compression and fluid retention capacity with or without compression and infection management. The use of Cutimed Siltec Sorbact dressing was beneficial in absorbing wound exudate (chi-square=28.45, P value<0.001), reduction of the viscosity of wound exudate (chi-square=25.63, P value<0.001), and there were more intact, less macerated, red and oedematous wound surroundings. There was also a 9% decrease in the number of infected wounds at the close-out visit. Analysis of the Wound-QoL measures demonstrated a reduction in the perception of performance parameters associated with wound infection. It can therefore be deduced that the use of Cutimed Siltec Sorbact was effective in wound management and had positive implications for patients' QoL.

Predicting the amputation risk for patients with diabetic foot ulceration - a Bayesian decision support tool.

BACKGROUND: Diabetes mellitus is a major global health issue with a growing prevalence. In this context, the number of diabetic complications is also on the rise, such as diabetic foot ulcers (DFU), which are closely linked to the risk of lower extremity amputation (LEA). Statistical prediction tools may support clinicians to initiate early tertiary LEA prevention for DFU patients. Thus, we designed Bayesian prediction models, as they produce transparent decision rules, quantify uncertainty intuitively and acknowledge prior available scientific knowledge. METHOD: A logistic regression using observational collected according to the standardised PEDIS classification was utilised to compute the six-month amputation risk of DFU patients for two types of LEA: 1.) any-amputation and 2.) major-amputation. Being able to incorporate information which is available before the analysis, the Bayesian models were fitted following a twofold strategy. First, the designed prediction models waive the available information and, second, we incorporated the a priori available scientific knowledge into our models. Then, we evaluated each model with respect to the effect of the predictors and validity of the models. Next, we compared the performance of both models with respect to the incorporation of prior knowledge. RESULTS: This study included 237 patients. The mean age was 65.9 (SD 12.3), and 83.5% were male. Concerning the outcome, 31.6% underwent any- and 12.2% underwent a major-amputation procedure. The risk factors of perfusion, ulcer extent and depth revealed an impact on the outcomes, whereas the infection status and sensation did not. The major-amputation model using prior information outperformed the uninformed counterpart (AUC 0.765 vs AUC 0.790, Cohen's d 2.21). In contrast, the models predicting any-amputation performed similarly (0.793 vs 0.790, Cohen's d 0.22). CONCLUSIONS: Both of the Bayesian amputation risk models showed acceptable prognostic values, and the major-amputation model benefitted from incorporating a priori information from a previous study. Thus, PEDIS serves as a valid foundation for a clinical decision support tool for the prediction of the amputation risk in DFU patients. Furthermore, we demonstrated the use of the available prior scientific information within a Bayesian framework to establish chains of knowledge.

Can Synthetic Images Improve CNN Performance in Wound Image Classification?

For artificial intelligence (AI) based systems to become clinically relevant, they must perform well. Machine Learning (ML) based AI systems require a large amount of labelled training data to achieve this level. In cases of a shortage of such large amounts, Generative Adversarial Networks (GAN) are a standard tool for synthesising artificial training images that can be used to augment the data set. We investigated the quality of synthetic wound images regarding two aspects: (i) improvement of wound-type classification by a Convolutional Neural Network (CNN) and (ii) how realistic such images look to clinical experts (n = 217). Concerning (i), results show a slight classification improvement. However, the connection between classification performance and the size of the artificial data set is still unclear. Regarding (ii), although the GAN could produce highly realistic images, the clinical experts took them for real in only 31% of the cases. It can be concluded that image quality may play a more significant role than data size in improving the CNN-based classification result.

Development and Evaluation of a Bayesian Risk Stratification Method for Major Amputations in Patients with Diabetic Foot Ulcers.

The diabetic foot ulcer, which 2% - 6% of diabetes patients experience, is a severe health threat. It is closely linked to the risk of lower extremity amputation (LEA). When a DFU is present, the chief imperative is to initiate tertiary preventive actions to avoid amputation. In this light, clinical decision support systems (CDSS) can guide clinicians to identify DFU patients early. In this study, the PEDIS classification and a Bayesian logistic regression model are utilised to develop and evaluate a decision method for patient stratification. Therefore, we conducted a Bayesian cutpoint analysis. The CDSS revealed an optimal cutpoint for the amputation risk of 0.28. Sensitivity and specificity were 0.83 and 0.66. These results show that although the specificity is low, the decision method includes most actual patients at risk, which is a desirable feature in monitoring patients at risk for major amputation. This study shows that the PEDIS classification promises to provide a valid basis for a DFU risk stratification in CDSS.

Automatic Classification of Diabetic Foot Ulcer Images - A Transfer-Learning Approach to Detect Wound Maceration.

Diabetic foot ulcer (DFU) is a chronic wound and a common diabetic complication as 2% - 6% of diabetic patients witness the onset thereof. The DFU can lead to severe health threats such as infection and lower leg amputations, Coordination of interdisciplinary wound care requires well-written but time-consuming wound documentation. Artificial intelligence (AI) systems lend themselves to be tested to extract information from wound images, e.g. maceration, to fill the wound documentation. A convolutional neural network was therefore trained on 326 augmented DFU images to distinguish macerated from unmacerated wounds. The system was validated on 108 unaugmented images. The classification system achieved a recall of 0.69 and a precision of 0.67. The overall accuracy was 0.69. The results show that AI systems can classify DFU images for macerations and that those systems could support clinicians with data entry. However, the validation statistics should be further improved for use in real clinical settings. In summary, this paper can contribute to the development of methods to automatic wound documentation.

Automatic Wound Type Classification with Convolutional Neural Networks.

Chronic wounds are ulcerations of the skin that fail to heal because of an underlying condition such as diabetes mellitus or venous insufficiency. The timely identification of this condition is crucial for healing. However, this identification requires expert knowledge unavailable in some care situations. Here, artificial intelligence technology may support clinicians. In this study, we explore the performance of a deep convolutional neural network to classify diabetic foot and venous leg ulcers using wound images. We trained a convolutional neural network on 863 cropped wound images. Using a hold-out test set with 80 images, the model yielded an F1-score of 0.85 on the cropped and 0.70 on the full images. This study shows promising results. However, the model must be extended in terms of wound images and wound types for application in clinical practice.

An Image Based Object Recognition System for Wound Detection and Classification of Diabetic Foot and Venous Leg Ulcers.

Venous leg ulcers and diabetic foot ulcers are the most common chronic wounds. Their prevalence has been increasing significantly over the last years, consuming scarce care resources. This study aimed to explore the performance of detection and classification algorithms for these types of wounds in images. To this end, algorithms of the YoloV5 family of pre-trained models were applied to 885 images containing at least one of the two wound types. The YoloV5m6 model provided the highest precision (0.942) and a high recall value (0.837). Its mAP_0.5:0.95 was 0.642. While the latter value is comparable to the ones reported in the literature, precision and recall were considerably higher. In conclusion, our results on good wound detection and classification may reveal a path towards (semi-) automated entry of wound information in patient records. To strengthen the trust of clinicians, we are currently incorporating a dashboard where clinicians can check the validity of the predictions against their expertise.