Can free flap transfer reduce the incidence of amputations in diabetic foot infection with peripheral artery disease?

Abstract

BACKGROUND: Diabetic foot ulcer is a frequent complication of Diabetes Mellitus which represents a major health concern worldwide. Most of the patients diagnosed have an infection as well as peripheral artery disease (PAD) concomitantly, which represents a relevant prognostic factor in wound healing. Currently, revascularization is indicated in most cases, except for a large area of tissue destruction in which treatment only consists of amputation or a palliative approach. On the other hand, recent studies have seen that despite standardized treatment for diabetic foot infection, patients still had infected non-healed wounds after a year of diagnosis and some patients had undergone amputation. As a result, amputation supposes an enormous burden on patients, families, and society with worsening quality of life. Therefore, this study is proposed to avoid amputation and the problems that this entails. OBJECTIVES: This study aims to compare standardized treatment with free flap transfer in the management of infected diabetic and PAD foot to reduce the incidence of amputations in comparison to standardized treatment.

As secondary objectives, we will assess whether the quality of life improves, the post- treatment complications and if there is a decrease in the recurrence of diabetic foot ulcers.

DESIGN: Multicenter, longitudinal, prospective, randomized, and open-labelled clinical trial, carried out in 2 hospitals in Catalonia. METHODS: Study subjects will be those diagnosed with diabetic foot infection and PAD. They will be randomly classified in 2 groups of 276 patients. The control group will receive the standardized treatment and the interventional group, in addition to standardized treatment will undergo reconstruction of the foot with free flap transfer. Patients will be followed-up for 3 years. The main study outcome will be the incidence of amputation. Secondary outcomes will include post-treatment complications, recurrence, and quality of life. The main hypothesis will be tested by calculating the relative risk and its corresponding 95% confidence interval