Negative pressure wound therapy versus standard wound care in chronic diabetic foot wounds: study protocol for a randomized controlled trial

Abstract

Background: In August 2010, the Federal Joint Committee (G-BA) decided that negative pressure wound therapy (NPWT) would not be reimbursable in German ambulatory care. This decision was based on reports from the Institute for Quality and Efficiency in Health Care (IQWiG), which concluded that there is no convincing evidence in favor of NPWT. The aim of this diabetic foot study (DiaFu study) is to evaluate whether the clinical, safety and economic results of NPWT are superior to the results of standard wound treatment.

Methods/design: The DiaFu study is designed as a national, multicenter, randomized controlled clinical superiority trial with a special focus on outpatient care in Germany. Competent patients in inpatient and outpatient care suffering from a chronic diabetic foot wound for a minimum of four weeks may be included in the study. The trial evaluates the treatment outcome of the application of a technical medical device which is based on the principle of NPWT (intervention group) in comparison to standard moist wound therapy (control group). All treatment systems used in the intervention group bear the symbol of free trade capacity in the European Union (CE mark) and will be operated within normal conditions of clinical routine and according to manufacturer's instructions. Primary endpoints are the time to complete wound healing and the rate of wound healing achieved in each group within the maximum study treatment time of 16 weeks. Primary endpoints will be confirmed by blinded assessment of wound photographs.

Discussion: The DiaFu study will provide solid evidence regarding the efficacy and effectiveness of NPWT until 31 December 2014, the date when G-BA plans to decide on future reimbursement of NPWT in both ambulatory and in-hospital care. The study is designed to comply with all quality requirements of G-BA and IQWiG and will contribute to evidence-based wound care in Germany. The study has been initiated by the statutory health insurance companies in Germany and is co-funded by two manufacturers of NPWT systems.

Trial registration: Clinical Trials.gov registration number: NCT01480362 (date of registration: 23 November 2011).German Clinical Trials Register number: DRKS00003347 (date of registration: 22 November 2011).

Figure 1

Stratification of DiaFu study participants according to Wagner-Armstrong classification. Participants of the DiaFu study are stratified by study center and by Wagner-Armstrong stage within each center (Group 1: <Wagner-Armstrong stage 2C and Group 2: ≥Wagner-Armstrong stage 2C). The table shows the modified Wagner-Armstrong classification scheme. Strata-Group 1 is marked blue and Strata-Group 2 is marked red.

Figure 2

DiaFu study sites. Recruitment of study patients is performed in hospitals and outpatient facilities across Germany with a specific qualification for the treatment of chronic diabetic foot wounds. The table lists all study sites ready for patient recruitment as of 25 October 2013.

Figure 3

Inclusion and exclusion criteria of the DiaFu study. The table shows the required diagnosis and the inclusion and exclusion criteria for DiaFu participants.