Comparing outcomes of oral versus intravenous antibiotic therapy for the treatment of the diabetic foot wound complicated by osteomyelitis

This pilot study aims to evaluate the feasibility of the methods and procedures used in order to guide a larger open-label randomised trial. In addition, this pilot study will examine the primary outcome measures and the ability to recruit 50 participants in a 6-month period. This study will also involve a cost analysis to compare the cost attributed to both groups. The study aims to measure and compare clinical outcomes for two clinical management strategies for the treatment of diabetic foot osteomyelitis, these are a) prolonged IV treatment and b) early commencement of oral antibiotic therapy (following a brief initial treatment with IV antibiotics); and to compare the quality of life of participants receiving prolonged treatment with an oral antibiotic strategy and those receiving prolonged treatment with an intravenous antibiotic strategy. Data regarding the infection (presence or absence and infection severity), the wound size and the participant’s quality of life will be collected at various time-points. There will also be three follow up visit at 4 weeks, 8 weeks and 12 weeks post cessation of antibiotic treatment, which will evaluate the infection (presence or absence and infection severity grade) and the wound size. Whilst an additional plain X-ray will be performed at 4 weeks post cessation of treatment in order to determine if the infection has resolved. The tentative hypothesis for the pilot study is that a treatment strategy of predominantly oral antibiotics with high oral bioavailability and expected high bone concentration will have a success rate equivalent to that of a strategy of six weeks of intravenous antibiotics, but a lower rate of major complications, a lower cost and a better quality of life. Although this pilot study will not formally test these hypotheses it will enable the researchers to assess the ability of these hypotheses to be formally tested in a future definitive randomised controlled trial.