An investigation in the reduction of wound volume in diabetic foot ulcers (DFUs) comparing NPWT VAC® device to a standard dressing - a single blinded randomized controlled trial (RCT).

Abstract

Diabetic foot ulcers (DFUs) are relatively common in the UK; 5–7% of people with Diabetes Mellitus currently have or have had a diabetic foot ulcer. Successful diagnosis and treatment of patients with DFUs involves wound healing using optimal wound dressings. Negative Pressure Wound Therapy (NPWT) has a significant role in healing of DFUs. There is very limited data available on the role of NPWT in healing of DFUs. RCTs with larger samples and adequate randomization are required to reinforce the role of NPWT in the management of DFUs. Therefore, this study is put forward to evaluate the role of negative pressure wound therapy in reducing wound volume of DFUs using a vacuum-assisted closure (VAC®) device. The aim of this study is to investigate the reduction of wound volume in diabetic foot ulcers (DFUs) comparing NPWT VAC® device to a standard dressing Mepitel® - a single blinded randomized controlled trial (RCT). A sample group of 80 participants will be used for this study with an equal number of participants assigned to the intervention group (NPWT via VAC® device) and to the control group (Mepitel® dressings). Reduction of DFU volume will be calculated using the Student t-test for percentage change in wound volume from the DFU’s baseline size (1st week) to the cut-off point of treatment (12th week). Quantitative data will be analysed using an inferential statistical test and results will be presented in graphs and will be rounded off to the nearest percentage.