An investigation of the clinical effectiveness of negative pressure wound therapy (NPWT) using a VAC® device in comparison to a conventional dressing (Activheal®) on diabetic foot ulcers (DFUs) - a single blinded randomized controlled trial (RCT) with a qualitative element.

Abstract / Lay summary Diabetic foot ulcers (DFUs) are relatively common in the UK; 5-7% of people with diabetes currently have or have had a diabetic foot ulcer (Wounds International 2013). Once a foot ulcer is present and there is poor arterial supply, a foot ulcer becomes more difficult to heal if the blood sugar levels are not controlled adequately and the risk of amputation occurring significantly increases (Sen et al. 2016). Successful diagnosis and treatment of patients with DFUs involves wound healing using optimal wound dressings. Nain et al. (2011) indicate that Negative Pressure Wound Therapy (NPWT) has a significant role in healing of DFUs. However, there is a gap in the literature for prospective single blinded RCTs in order to fully evaluate the effect of NPWT in the healing of DFUs (Vig et al. 2011; Meloni et al. 2015). The aim of this study is to determine the clinical effectiveness of NPWT using a VAC® (vacuum-assisted closure) device in comparison to a conventional dressing (Activheal®) on DFUs by conducting a single blinded RCT with a qualitative element. A sample group of 40 participants will be used for this study and there will be equal numbers of patients who are treated with the VAC® device and Activheal®. The quantitative results will be analysed using descriptive and inferential statistics and the qualitative results will be assessed using thematic analysis. Data will be analysed using computer package SPSS version 19 and data will be illustrated using graphs.msc_diaunpub2950_ethesesunpu