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Article History

Received: 20 December 2021

Accepted: 24 August 2022

First Online: 30 September 2022

Declarations

:

: The study protocol and the informed consent documents were approved by the lead ethical committee (EC) of the Witten/Herdecke University. Ethical approval has been fully granted without any conditions. Due to performing the trial according to § 23b MPG (German Medical Device Act), participating study sites in Germany only received a consultation for the main clinical investigator according to professional law by the respective EC. All investigators have been fully approved by the respective ECs. An evaluation of the study’s content by ECs of participating study sites in Germany was not applicable.Written informed consent was obtained from every patient after being informed about all aspects of the trial, and before randomization and any trial-related procedure.

: Not applicable.

: The German statutory health insurance companies commissioned the Witten/Herdecke University (UW/H) to plan, conduct, analyze and publish the study. DS was an employee of the UW/H. RL 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 organized by the manufacturer Hartmann. All clinical investigators received a case fee for each patient included in the DiaFu study in order to compensate for the additional organizational 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.