Review question/objective The objective of this review is to systematically review the evidence to determine the best available evidence related to methods of off-loading to prevent the development of foot ulcers in adults with diabetes. More specifically, the review question is to identify: What is the effectiveness of methods of off-loading to prevent diabetic foot ulcers in adults with diabetes? Inclusion criteria Types of participants This review will consider studies that include adults 18 years and older with diabetes mellitus regardless of age, gender, ethnicity, duration of diabetes, type of diabetes in any clinical setting. Types of intervention(s)/phenomena of interest This review will consider studies that evaluate all off-loading methods and strategies (excluding surgical interventions such as Achilles tendon lengthening). Interventions to be considered include mechanical external methods of off-loading, used prior to the development of a primary ulcer or break in the skin of the foot or lower leg. These may include, but are not limited to; padding: in-shoe and attached to the foot, customised insoles, customised orthotic devices, customised footwear and rocker-soled shoes. Types of outcomes The primary outcome of interest will be the prevalence of foot ulcers associated with diabetes mellitus. Secondary outcomes will include measurable changes in pressure on the skin of the foot and may include, but are not limited to; visual, mechanical or computerised methods