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Diabetes mellitus (DM) is a significant public health issue in Germany, affecting 8 million individuals, with projections suggesting a substantial increase in the following years. Diabetic Foot Syndrome (DFS), leading to mobility issues and limb amputations, challenging healthcare due to resource shortages and the need for specialized care. The EPWUF-KI project seeks to support outpatient caregivers by incorporating artificial intelligence (AI) into DFS wound care, focusing on optimizing treatment and automating documentation.

Background: Offloading is the cornerstone of treatment of plantar diabetic foot ulcers. It limits mobility with consequent psychological and cardiovascular side effects, and if devices are removed, healing is delayed., Methods: We developed three non-removable techniques with increasing offloading potential (multilayer felt sole, felt-fiberglass sole, or total contact casts with ventral windows) and sensors built within. Smartwatch and web apps displayed pressure, temperature, humidity, and steps. They alerted patients, staff, and a telemedicine center when pressure limits (125 kPa) were exceeded. Patients were advised to walk as much as they had done before the ulcer episode. To evaluate the potential of this intervention, we enrolled 20 ambulatory patients in a randomized clinical trial. The control group used the same offloading and monitoring system, but neither patients nor therapists received any information or warnings., Results: Three patients withdrew consent. The median time to healing of ulcers was significantly shorter in the intervention group compared with controls, 40.5 (95% confidence interval [CI] = 28-not applicable [NA]) versus 266.0 (95% CI = 179-NA) days ( P = .037), and increasing ulcer area was observed less frequently during study visits (7.9% vs 29.7%, P = .033). A reduction of wound area by 50% was reached at a median of 10.2 (95% CI = 7.25-NA) versus 19.1 (95% CI = 13.36-NA) days ( P = .2). Participants walked an average of 1875 (SD = 1590) steps per day in intervention group and 1806 (SD = 1391) in the control group., Conclusions: Sensor-assisted wound therapy may allow rapid closure of plantar foot ulcers while maintaining patient's mobility during ulcer therapy., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Irremovable total contact casts (TCCs) are the gold standard to offload diabetic foot ulcers (DFUs) and to immobilize feet with active Charcot neuro-osteoarthropathy (CN). They do not allow checks of the foot and are contraindicated in people with peripheral arterial disease (PAD). Frequently, removable TCCs and other removable devices are used because they allow wound care, modifications of the inner surface of the cast, and checks of the foot. The authors propose TCCs with ventral windows (VW-TCCs) whenever patients with high-risk conditions show poor adherence to wearing a removable cast all the time and access to the foot is necessary., Methods: This retrospective study compares treatments with bivalved, removable TCCs applied prior to the introduction of the novel design (from 1 January 2016 to 1 July 2017, " c ") to treatments in the following period ( t ) with both bivalved removable TCCs and VW-TCCs in use., Results: Forty-five treatments after introduction (17 with the VW-TCC) showed a 52.8% lower median time to reach remission of the DFS than 41 controls (128/267 days, log-rank test P  = .013). Reasons given for not using the novel design were: sufficient offloading with a removable TCC (16), patient preference (six), anatomical conditions (two), casts applied as a service for other facilities (three), and calf ulcers (one). Adverse effects from both designs were uncommon and not severe., Conclusions: VW-TCCs combine advantages of both removable and irremovable TCCs. Complications do not limit the use, even in patients with PAD.

Diabetic foot syndrome (DFS) is the most frequent reason for major amputations in Germany. The majority of foot lesions are triggered by repetitive pressure in diabetic polyneuropathy. Peripheral arterial occlusive disease (PAOD) impairs wound healing and is the main risk factor for amputations. The treatment of wounds and infections as well as timely revascularization are decisive. The use of endovascular and vascular surgical methods depends on the distribution pattern and length of the occlusion processes. Both procedures are complementary. Bypass surgery is of great importance for neuroischemic DFS. Multidisciplinary centers that provide revascularization in DFS can achieve an improvement of arterial blood flow in 90% of the cases and reduce the amputation rate by up to 80%. Due to the high recurrence rate of diabetic foot lesions, measures for secondary prophylaxis are of exceptional importance (podological and orthopedic technical care, foot surgery).

There are ca. 8 million persons with diabetes mellitus living in Germany. A late sequelae of diabetes is the diabetic foot syndrome (DFS), the prevalence of which is greatly increasing. It comprises all alterations of the foot as a result of diabetic polyneuropathy as well as microvascular and macrovascular (peripheral arterial occlusive disease, PAOD) alterations. Many of the ca. 250,000 newly diagnosed diabetic foot ulcers per year become chronic wounds. Despite intensive efforts for prevention, early diagnosis and adequate wound care, ca. 13,000 persons with diabetes undergo major limb amputation in Germany every year. With consistent treatment in interdisciplinary centers and by exhausting all possible methods of wound treatment, pressure relief as well as arterial revascularization, the major amputation rate in patients with diabetic foot problems can be reduced by 80%. With a suitable strategy of prevention, the recurrence rate of foot ulcers would be reduced.

Objectives: The aim of the DiaFu study was to evaluate effectiveness and safety of negative pressure wound therapy (NPWT) in patients with diabetic foot wounds in clinical practice., Design: In this controlled clinical superiority trial with blinded outcome assessment patients were randomised in a 1:1 ratio stratified by study site and ulcer severity grade using a web-based-tool., Setting: This German national study was conducted in 40 surgical and internal medicine inpatient and outpatient facilities specialised in diabetes foot care., Participants: 368 patients were randomised and 345 participants were included in the modified intention-to-treat (ITT) population. Adult patients suffering from a diabetic foot ulcer at least for 4 weeks and without contraindication for NPWT were allowed to be included., Interventions: NPWT was compared with standard moist wound care (SMWC) according to local standards and guidelines., Primary and Secondary Outcome Measures: Primary outcome was wound closure within 16 weeks. Secondary outcomes were wound-related and treatment-related adverse events (AEs), amputations, time until optimal wound bed preparation, wound size and wound tissue composition, pain and quality of life (QoL) within 16 weeks, and recurrences and wound closure within 6 months., Results: In the ITT population, neither the wound closure rate (difference: n=4 (2.5% (95% CI-4.7% - 9.7%); p=0.53)) nor the time to wound closure (p=0.244) was significantly different between the treatment arms. 191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes. 96 participants in the NPWT arm and 72 participants in the SMWC arm had at least one AE (p=0.007), but only 16 AEs were related to NPWT., Conclusions: NPWT was not superior to SMWC in diabetic foot wounds in German clinical practice. Overall, wound closure rate was low. Documentation deficits and deviations from treatment guidelines negatively impacted the outcome wound closure., Trial Registration Numbers: NCT01480362 and DRKS00003347., Competing Interests: Competing interests: The German statutory health insurance companies commissioned the Witten/Herdecke University (UW/H) to plan, conduct, analyse and publish the study. DS is an employee of the UW/H. The study has been financed by the manufacturers KCI (Acelity) and S&N. DS received a consulting fee for the presentation of the study during an event organised by the manufacturer Hartmann. During study planning and conduct, EN was an employee of the UW/H. He was the director of the Institut für Forschung in der Operativen Medizin. The clinical investigators MS, HL, GW, PM, DH, WW-R, KS, MH, GR, TK and KZ received a case fee of 1000€ for each patient included in the DiaFu study in order to compensate for the additional organisational and especially the documentation effort during trial conduct. Furthermore, all investigators received compensation for travelling to the investigator meetings. The institutions of the investigators used integrated care contracts for NPWT during study conduct in order to provide best practice for the study participants during outpatient care. GW and WW-R are members of the scientific advisory board of the manufacturer KCI (now Acelity)., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Elimination of plantarization of the tip of the toe and torsion of digit 1 (D1) or D5 using percutaneous tenotomy of the flexor hallucis longus (FHL) - or the flexor digitorum longus (FDL) muscle., Indications: Flexible, in some cases also fixated hyperflexion misalignment and torsion misalignment of the distal phalanx of the toe with plantarization of physiologically non-loaded bearing parts of the toes in patients with diabetic foot syndrome (neuropathy)., Contraindications: Critical limb ischemia., Surgical Technique: Percutaneous tenotomy of the FHL or FDL tendons using the minimally invasive lancet technique without the use of a tourniquet while the tendon is flexed by causing hyperextension of the distal phalanx and simultaneous extension of the distal interphalangeal (DIP) or interphalangeal (IP) joints., Postoperative Management: Immediate full weight-bearing mobilization in sufficiently wide protective footwear with customized cushioning or a diabetes-adapted foot bed, follow-up in initially frequent intervals (2-4 per week) in order to track the development of the transfer lesions. In the case of existing wounds, more frequent visits and relief of the wounds using a post-operative shoe are required. No thrombosis prevention with full weight-bearing is necessary., Results: In 138 patients with diabetic foot syndrome with polyneuropathy, of which 90 were men (65.2 %) and 48 were women (34.8 %) with a median age of 65.1 years, a total of 291 toe operations with tenotomy of the FHL- or FDL-tendon were performed. Patients were either acutely affected by apical toe lesions (92.1 %) or showed an increased risk of ulcer formation (7.9 %). The median time to closing of the wound was 13 days. It was longer with higher Wagner stages. Of the surgically treated toes 3.1 % were affected by nosocomial infections. At the 1‑year follow-up 92.4 % of the patients did not show pathological results of the operated toe. Recurrence of the DFS occurred mostly during the first 6 months postoperatively. In the first year postoperatively 68.1 % of the patients remained in remission. Of the toes with Wagner grade 0, 93.7 % were free of local recurrence during the entire monitoring period and 72.2 % of the operated toes with Wagner grade 3. Within the first 1.5-8.5 months 13 % of the patients were affected by transfer lesions.

Aim: In two German regions with 11.1 million inhabitants, 6 networks for specialized treatment of DFS were implemented until 2008. Data provided for accounting purposes was analysed in order to determine changes in the rate of diabetics requiring amputations in the years before and after the implementation., Method: Data covering 2.9 million people insured by the largest insurance company between 2007 and 2013 was analysed by the use of log-linear Poisson regression adjusted for age, gender and region., Results: The rate of diabetics needing major amputations fell significantly by 9.5% per year (p < 0.0001) from 217 to 126 of 100,000 patients per year. The rate of diabetics needing amputations of any kind fell from 504 to 419 of 100,000 patients per year (p = 0.0038)., Discussion: The networks integrate health care providers in an organised system of shared care. They educate members of the medical community and the general public. At the same time, a more general disease management program for people with diabetes was implemented, which may also have contributed to this decrease. At the end of the observation period, the rate of diabetics requiring amputations was still high. For this reason, further expansion of organised specialized care is urgently needed.

Background: Using the information of the federal statistics, a detailed description of the hospitalisation rate for amputation in Germany was possible for the first time, and trends since 2005 can be reported., Patients and Methods: Detailed lists of all amputations coded as minor amputations (OPS 5 - 864) and major amputations (OPS 5 - 865) performed in 2005 and 2008, divided into the 4th and 5th number of the OPS-code, were provided by the Federal Statistical Office., Results: Despite an increase in total number of hospitalized patients suffering from peripheral arterial disease and neurovascular disease there is a relevant decrease in age adjusted major amputation rates per 100.000 population in Germany from 27.0 in 2005 to 25.1 in 2008 in males and from 19.7 in 2005 to 17.1 in 2008 in females. Overall minor amputation rates do not show such a decrease but increased in males (from 47.4 in 2005 to 53.7 in 2008) und remained unchanged in females (23.1 in 2005 and 23.1 in 2008). In the 6th and 7th decade of life males have approximately four times higher major and minor amputation rates than females., Conclusions: Hospitalisation rate for major amputation in Germany decreased in the recent years whereas hospitalisation rate for minor amputation did not.

The benefit of good blood pressure control in patients with arterial hypertension has been repeatedly demonstrated. In high risk patients, a good blood pressure control is one of the main prerequisites for the reduction in morbidity and mortality. However, as shown in population-based studies, the quality of blood pressure control both in patients with essential hypertension and in hypertensive diabetic patients is still unsatisfactory. Only a minority of patients achieve target blood pressure values below 140/90 mm Hg. This situation has not changed within the recent years, although the prescriptions of antihypertensive drugs have continuously increased. This paper describes a structured hypertension treatment and teaching programme (HTTP) which was developed and evaluated during the last 16 years and which aims at intensification of antihypertensive therapy by active involvement of the patient in his own treatment. This programme primarily focuses on the improvement of the patients' long-term treatment compliance by means of information about non-pharmacological and pharmacological therapies and instructions to regular blood pressure self measurements. The efficacy and feasibility of the HTTP has been evaluated in several studies which unanimously show considerable benefits not only concerning blood pressure control but, most importantly, regarding reduction in the incidence and progression of hypertension associated diseases as cerebro- and cardiovascular events and diabetic nephropathy. Therefore, it seems essential to implement the HTTP in the German health care system in order to finally achieve the desired quality of care for patients with arterial hypertension.