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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.

OBJECTIVE: We evaluated whether the incidence of amputations in one German city (Leverkusen, population approximately 160,000) had decreased between 1990 and 2005. RESEARCH DESIGN AND METHODS: From all three hospitals in the city, we obtained complete lists of nontraumatic lower-limb amputations in 1990-1991 and 1994-2005. Only the first observed amputation in residents of Leverkusen was counted. A total of 692 patients met the inclusion criteria. Data about the population structure, separately for each year of the observation period, were received from the city administration and the Federal Office of Statistics. To test for time trend, we fitted Poisson regression models. RESULTS: Of all subjects, 72% had known diabetes and 58% were male. Mean age was 71.7 years. Incidence rates in the diabetic population (standardized to the estimated German diabetic population per 100,000 person-years) varied considerably between years (maximum 549 in 1990, minimum 281 in 2004). In the diabetic population, the estimated relative risk (RR) per year was 0.976 (95% CI 0.958-0.996, P = 0.0164). The same trend was observed when only amputations above the ankle (n = 352) (RR 0.970 [95% CI 0.943-0.997], P = 0.0318) were considered. Over 15 years, an estimated reduction of amputations above the toe level by 37.1% (95% CI 12.3-54.8) results. There was no significant change of incident amputations in the nondiabetic population (RR 1.022 [0.989-1.056], P = 0.1981). CONCLUSIONS: This finding is likely to be due to improved management of the diabetic foot syndrome after a network of specialized physicians and defined clinical pathways for wound treatment and metabolic control were introduced. [ABSTRACT FROM AUTHOR]

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.)