TLC-Ag dressings: a prospective, multicentre study on 728 patients with wounds at risk of or with local infection.

OBJECTIVE: This study aimed to evaluate the management of an unselected cohort of patients with wounds at risk of or with clinical signs of local infection, treated with two antimicrobial contact layers impregnated with silver (TLC-Ag healing matrix), under real-life conditions during the COVID-19 pandemic. METHOD: A large, prospective, multicentre, observational study with two TLC-Ag dressings (UrgoTul Ag/Silver and UrgoTul Ag Lite Border, Laboratoires Urgo, France) was conducted in Germany between May 2020 and May 2021. The main outcomes included a description of the treated patients and their wound management, the changes in wound infection and wound healing outcomes over a maximum period of four weeks of treatment, as well as the overall clinical assessment of the performance, local tolerance and acceptability of dressings. RESULTS: A total of 728 patients with wounds of various aetiologies and wound infection status were treated with the evaluated dressings in 39 centres for a mean duration of 26±19 days, with an intermediate visit conducted in 712 (97.8%) patients after a mean period of 12±9 days. At the initial visit, it was established that the majority of patients (60.4%) had a wound infection, while the remaining cohort presented first clinical signs of a local wound infection (25.1%) or were at risk of wound infection (13.2%) (unclear status in 1.2%). Throughout the study period, all the parameters of wound infection continuously decreased, resulting at the final visit in a reduction by 78.9% of the prevalence of local wound infections and by 72.0% of the clinical signs of wound infection, the most rapidly diminished clinical sign being wound deterioration. Concurrently, in terms of the healing process, 92.1% of the wounds healed or improved, 3.2% remained unchanged and 1.7% worsened (data missing for 3.0%), and an improvement of the periwound skin was reported in 65.7% of the patients. Overall, the two dressings were 'very well accepted' by the majority of patients, with no uncomfortable feeling at wearing and no pain at dressing removal, and were assessed by the physicians as 'very useful' in the majority of the cases with a 'very good' efficacy in terms of antimicrobial activity and promotion of the wound healing process. Similar results were reported regardless of the wound type treated or of the TLC-Ag dressing evaluated. CONCLUSION: These results are consistent with previous clinical evidence on TLC-Ag dressings. They support the good efficacy, good tolerability and usefulness of these antimicrobial dressings in the management of patients with wounds at risk or with clinical signs of local infection, in association with appropriate standard of care.

Characteristics of new patient referrals to specialised diabetic foot units across Europe and factors influencing delays.

OBJECTIVE: Foot ulcers are a common complication of diabetes and are associated with an increase in lower limb amputation and death. Early referral to a specialised unit is recommended. The aim of this study was to assess the characteristics of new-patient referrals to specialised diabetes foot care units across Europe and to determine the factors involved in delayed referral. METHOD: In this prospective observational study, consecutive patients with a new foot ulcer presenting to nine diabetic foot centres in five European countries (France, Germany, Italy, Spain and the UK) were included. RESULTS: Some 25% of the 332 patients included had presented with a foot ulcer >3 months before referral to the participating foot clinic. Compared with patients referred earlier, patients with a long time to referral (>3 months) were older (p=0.006) and had a less severe wound according to Infectious Diseases Society of America (IDSA) classification (p=0.003) and University of Texas classification (grade D=infection + peripheral artery disease, p=0.004). CONCLUSION: The proportion of patients with a diabetic foot ulcer (DFU) referred to a specialised unit >3 months after the beginning of the ulcer remained high throughout Europe. Patients with severe DFU were, however, referred more quickly by front line health professionals. Primary care professionals need to be made aware of the importance of early referral to a specialised unit in order to improve the management of foot disease in patients with diabetes. DECLARATION OF INTEREST: The authors have no conflicts of interest to declare.

Impact of wound duration on diabetic foot ulcer healing: evaluation of a new sucrose octasulfate wound dressing.

OBJECTIVE: A common and frequent complication of diabetes is diabetic foot ulcers (DFU), which can have high treatment costs and severe adverse events. This study aims to evaluate the effects of wound duration on wound healing and the impact on costs, including treatment with a new sucrose octasulfate dressing compared with a control dressing. METHOD: Based on the Explorer study (a two-armed randomised double-blind clinical trial), a cost-effectiveness analysis compared four different patient groups distinguished by their wound duration and additionally two DFU treatment options: a sucrose octasulfate dressing and a neutral dressing (as control). Clinical outcomes and total direct costs of wound dressings were evaluated over 20 weeks from the perspective of the Social Health Insurance in Germany. Simulation of long-term outcomes and costs were demonstrated by a five cycle Markov model. RESULTS: The results show total wound healing rates between 71% and 14.8%, and direct treatment costs for DFU in the range of €2482-3278 (sucrose octasulfate dressing) and €2768-3194 (control dressing). Patients with a wound duration of ≤2 months revealed the highest wound healing rates for both the sucrose octasulfate dressing and control dressing (71% and 41%, respectively) and had the lowest direct treatment costs of €2482 and €2768, respectively. The 100-week Markov model amplified the results. Patients with ≤2 months' wound duration achieved wound healing rates of 98% and 88%, respectively and costs of €3450 and €6054, respectively (CE=€3520, €6864). Sensitivity analysis revealed that the dressing changes per week were the most significant uncertainty factor. CONCLUSION: Based on the findings of this study, early treatment of DFU with a sucrose octasulfate dressing is recommended from a health economic view due to lower treatment costs, greater cost-effectiveness and higher wound healing rates.

Referral of patients with diabetic foot ulcers in four European countries: patient follow-up after first GP visit.

OBJECTIVE: This study aimed to analyse the characteristics of patients, including demographics, medical history and treatment, with a diabetic foot ulcer (DFU) during their first follow-up visit to a general practitioner (GP). METHODS: A two-part quantitative online questionnaire was distributed among GPs in France, UK, Germany and Spain. Part one entailed a survey of GPs' perceptions of referrals for DFU. Part two collected data on recently managed DFU cases. The percentage of responses was compared for each question and across the four countries for significant differences. RESULTS: In part one of the study, 600 questionnaires were collected (150 per country) and 1188 patients managed for a DFU were included in the second part. About 88% of patients had type 2 diabetes, with a significant proportion of suboptimal control (average HbA1c: 10.64mmol/l). A patient complaint led to diagnosis in 60% of the cases. Wounds were found to be more frequently located in the toes and midfoot, and were superficial (according to the Texas Wound Classification system) in 80% of the cases. More than two-thirds of patients developed small wounds (<5cm2); more than half of them had infected wounds. Approximately 50% of wounds were ischaemic, which triggered the onset of a DFU. Follow-up wound examinations before and after hospitalisation were performed by nurses, except in Germany where GPs undertook this role, including prescribing offloading devices and in the UK where follow-up was managed by podiatrists. Ischaemia, wound necrosis, suspected osteomyelitis and absence of wound healing were the primary reasons for hospital admission during the first month after diagnosis. CONCLUSION: Delay in specialised foot care is a recurring topic in the treatment of DFUs, even with different health-care structures across Europe. Knowledge and education on DFUs should be reinforced among GPs and nurses to establish a global DFU care network between primary and specialised care, avoid hospitalisation and adequately manage high-risk patients.

Perception of diabetic foot ulcers among general practitioners in four European countries: knowledge, skills and urgency.

OBJECTIVE: Diabetic foot ulcers (DFU) have the potential to deteriorate rapidly, in the absence of prompt assessment and treatment. The aim of this study was to analyse the awareness and perception of DFU among general practitioners (GPs) from four European countries, and to find possible differences between these countries in terms of management. METHOD: A two-part, quantitative, online questionnaire was distributed to GPs across four countries in Europe-the UK, France, Germany and Spain. The first part entailed a survey on the perception and knowledge of the pathogenesis and management of DFU, among GPs. The second part of the questionnaire was used for the collection of data on recently-managed DFU cases. RESULTS: For the first part of the study, 600 questionnaires were collected (150 per country) and 1188 patient cases of DFU management were included in the second part. In France, only 49% of GPs mentioned neuropathy as the main causative process in DFU development. However, in Germany and the UK, 82% and 83% of GPs, respectively, considered neuropathy as an important causative factor. DFU care in Spain and the UK is thought to be organised by multidisciplinary teams (MDT) (83% and 84% of GPs, respectively, completely agreed with this statement). In France and Germany, GPs are responsible for follow-up and management. Only UK physicians have clearly identified specialised podiatrists to refer patients to, if needed. Approximately 29-40% of GPs in all countries did not feel they were sufficiently trained in the DFU treatment protocol. Almost 30% of GPs in France and Germany thought that DFU treatment was not well-established due to the absence of clinical guidelines and protocols. CONCLUSION: The intra-country and inter-country management of the complex aspects of DFU is quite heterogeneous. The cause of this finding is multifactorial. Although there are international guidelines, it would be beneficial to establish clear and specific competencies for the different health professionals involved in DFU management. As a minimum, intra-country heterogeneity should improve with their development.

Delayed referral of patients with diabetic foot ulcers across Europe: patterns between primary care and specialised units.

OBJECTIVE: Diabetic foot ulceration (DFU) has the potential to deteriorate rapidly without prompt assessment and treatment. The aim of this study was to assess the referral patterns for DFU, from primary care to specialised diabetes foot care units. METHOD: A two-part, quantitative, online questionnaire was administered to GPs across four countries in Europe: France, the UK, Germany and Spain. The first part entailed a survey of GPs' perceptions of referrals for DFU. The second part of the questionnaire collected data on recently managed DFU cases. RESULTS: There were 600 questionnaires collected in the first part of the study (150 per country), and 1188 patient cases of DFU management were included in the second part. Up to 95% of patients had type 2 diabetes. Patients' complaints led to diagnosis, on average, 60% of the time, and the diagnosis was an incidental finding during a consultation 13-28% of the time. On average, only 40% of GPs completely agreed that they have clearly identified DFU clinical practitioners working in a hospital facility. In 55-66% of cases, the duration of DFU was unknown or DFU diagnosis was delayed more than three weeks from the onset of the wound. On average, 48% of patients were referred after an unknown duration or more than one month from the onset of DFU. CONCLUSION: Despite differences in health-care structures across Europe, delays in referral to specialist foot care teams seems to be a common theme. There is an ongoing need to educate GPs, nurses and patients to be more aware of the risk of DFU, and the need for prompt referral to specialist diabetic foot teams.