The performed analysis aimed to evaluate the clinical benefit of NPWT in comparison with conventional forms of wound care, and to compare the benefit of various forms of NPWT for acute and chronic wounds with regard to patient-relevant outcomes on the basis of the published literature. The IQWiG is an independent non-profit and non-government scientific institute that receives commissions from the Federal Joint Committee and the German Ministry of Health. The G-BA is the legislative institution of the German healthcare self-administration system. In 2004 the German Federal Joint Committee (Gemeinsamer Bundesausschuss (G-BA)) commissioned an analysis of the available studies regarding NPWT to the Institute for Quality and Efficiency in Healthcare (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)) to support decision-making on the reimbursement of NPWT by the German statutory health insurance funds. Recent history of NPWT - clear evidence is still missing The occurrence of impaired wound-healing represents a multi-disciplinary treatment and cost-intensive clinical problem whether it is caused by infectious or non-infectious reasons. Complications associated with non-healing wounds range from inconvenient to life threatening and can be more common and serious than those related to the underlying disease. Acute and chronic wounds with healing impairment are a common problem of healthcare. Due to arterial abnormalities and diabetic neuropathy, as well as a tendency to delay wound healing, infection or gangrene of the foot may develop. The Diabetic foot wound is a common and frequent secondary syndrome that can lead to amputation. The WHO has estimated that 2.5 to 15% of annual national healthcare budgets are spent on diabetes-related illness alone. Diabetes and its sequelae cause significant economic consequences on individuals, families, health systems and countries. Diabetes management involves a variety of costs and imposes enormous resource burdens, both on the individual and on healthcare systems. Both organizations estimate that in 2030 the number of those diagnosed will have almost doubled, mainly due to demographic changes. Even higher numbers have been predicted by the International Diabetes Federation (IDF), who reported in 2003 that 194 million adults were diagnosed with diabetes. The World Health Organization (WHO) estimates that more than 180 million people worldwide suffer from diabetes. These disturbances result from an inability of the pancreas to produce enough insulin, the body’s inability for an effective use of the produced hormone, or both. It is characterized by chronic hyperglycemia and disturbances in carbohydrate, fat and protein metabolism. Primary endpoints will be confirmed by blinded assessment of wound photographs.ĭiabetes mellitus (DM) is a prevalent global chronic disease and describes a metabolic disorder. 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. 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. 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). 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 DiaFu study is designed as a national, multicenter, randomized controlled clinical superiority trial with a special focus on outpatient care in Germany.
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