PMID- 32209619 OWN - NLM STAT- MEDLINE DCOM- 20210215 LR - 20210215 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 10 IP - 3 DP - 2020 Mar 24 TI - 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. PG - e026345 LID - 10.1136/bmjopen-2018-026345 [doi] LID - e026345 AB - 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. CI - (c) 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. FAU - Seidel, Dorthe AU - Seidel D AUID- ORCID: 0000-0002-2287-5217 AD - Institut fur Forschung in der Operativen Medizin (IFOM), Universitat Witten/Herdecke, Koln, Germany Doerthe.Seidel@uni-wh.de. FAU - Storck, Martin AU - Storck M AD - Klinik fur Gefass- und Thoraxchirurgie, Stadtisches Klinikum Karlsruhe gGmbH, Karlsruhe, Germany. FAU - Lawall, Holger AU - Lawall H AD - Praxis fur Herzkreislauferkrankungen, Ettlingen, Germany. AD - Innere Medizin, Max-Grundig Klinik, Buhlerhohe, Germany. FAU - Wozniak, Gernold AU - Wozniak G AD - Gefasschirurgische Klinik, Knappschaftskrankenhaus Bottrop GmbH, Bottrop, Germany. FAU - Mauckner, Peter AU - Mauckner P AD - Innere Medizin, St. Remigius Krankenhaus Opladen, Leverkusen, Germany. FAU - Hochlenert, Dirk AU - Hochlenert D AD - Gemeinschaftspraxis Schlotmann-Hochlenert-Zavaleta-Haberstock, Koln, Germany. FAU - Wetzel-Roth, Walter AU - Wetzel-Roth W AD - Chirurgische Praxis Wetzel-Roth, Buchloe, Germany. FAU - Sondern, Klemens AU - Sondern K AD - Klinik fur Innere Medizin/Diabetologie, Marien Hospital Dortmund-Hombruch, Dortmund, Germany. FAU - Hahn, Matthias AU - Hahn M AD - Allgemein- und Viszeralchirurgie, Helfenstein Klinik, Geisslingen, Germany. FAU - Rothenaicher, Gerhard AU - Rothenaicher G AD - Chirurgische Praxis Rothenaicher, Munchen, Germany. FAU - Kronert, Thomas AU - Kronert T AD - Klinik fur Gefasschirurgie, Thuringen-Kliniken "Georgius Agricola" GmbH, Saalfeld, Germany. FAU - Zink, Karl AU - Zink K AD - Diabetes Klinik, Diabetes Zentrum Mergentheim, Bad Mergentheim, Germany. FAU - Neugebauer, Edmund AU - Neugebauer E AD - Department fur Humanmedizin, Universitat Witten/Herdecke, Witten, Germany. AD - Medizinische Hochschule Brandenburg -Theodor Fontane, Neuruppin, Germany. LA - eng SI - ClinicalTrials.gov/NCT01480362 SI - DRKS/DRKS00003347 PT - Equivalence Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20200324 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Diabetic Foot/*therapy MH - Female MH - Follow-Up Studies MH - Germany MH - Humans MH - Intention to Treat Analysis MH - Male MH - Middle Aged MH - *Negative-Pressure Wound Therapy MH - *Occlusive Dressings MH - Severity of Illness Index MH - Single-Blind Method MH - Treatment Outcome MH - Wound Healing PMC - PMC7202734 OTO - NOTNLM OT - benefit assessment OT - diabetic foot OT - negative pressure wound therapy OT - wound care OT - wound healing OT - wound treatment COIS- 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 fur 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 1000euro 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). EDAT- 2020/03/27 06:00 MHDA- 2021/02/16 06:00 PMCR- 2020/03/23 CRDT- 2020/03/27 06:00 PHST- 2020/03/27 06:00 [entrez] PHST- 2020/03/27 06:00 [pubmed] PHST- 2021/02/16 06:00 [medline] PHST- 2020/03/23 00:00 [pmc-release] AID - bmjopen-2018-026345 [pii] AID - 10.1136/bmjopen-2018-026345 [doi] PST - epublish SO - BMJ Open. 2020 Mar 24;10(3):e026345. doi: 10.1136/bmjopen-2018-026345.