TBM project - Towards Pressure-Adherence & Education Driven Service in Diabetic Foot Disease (PARADISE trial)

Foot complications (so-called Diabetes-related foot disease (DFD)) are among the most serious
complications of diabetes mellitus. These complications may have a substantial impact on patients’
quality of life and well-being. Treatment of foot ulcers is challenging since these are typically caused
by neuropathy, repetitive trauma, foot deformity and high plantar pressures. Even when a foot ulcer
is healed, the risk of recurrence remains high. Management of high peak pressures and foot
deformities typically encompass pressure-relieving therapeutic interventions (e.g. therapeutic
footwear that patients should wear most of the time). Critical appraisal highlights two specific
weaknesses in current practice of diabetic foot clinics. First, there is suboptimal practice regarding
pressure monitoring and off-loading of the at-risk foot. Secondly, there is suboptimal practice about
the monitoring and optimization of footwear adherence in these patients. A number of barriers are
responsible for this suboptimal management and these will be addressed in the current project. The
main objective of the project is to conduct a Phase III clinical trial evaluating a pressure-adherence
and education driven service in recognized diabetic foot clinics in Flanders. The population in the
current project encompasses patients with DFD and a high risk of (recurrent) foot ulcers (P). The
clinical application will be oriented towards quantification of the therapeutic efficacy (I)) of 1)
pressure driven foot orthotics and 2) adherence monitoring-supportive interventions. In a multicentre
parallel group RCT, we will compare the foot ulcer recurrence rate (O) of patients receiving socalled
‘optimal care’ and ‘usual care’ (C).