Sensor-Assisted Wound Therapy in Plantar Diabetic Foot Ulcer Treatment: A Randomized Clinical Trial.

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.

Ventral Windowed Total Contact Casts Safely Offload Diabetic Feet and Allow Access to the Foot.

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.

Negative pressure wound therapy compared with standard moist wound care on diabetic foot ulcers in real-life clinical practice: results of the German DiaFu-RCT.

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.

Decrease in (Major) Amputations in Diabetics: A Secondary Data Analysis by AOK Rheinland/Hamburg.

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.