People at risk of foot ulceration with loss of protective sensation do not sense tissue breakdown, and therefore may miss the urgency to wear their custom-made footwear at all times, including inside the house. The Dr. HOUSE trial provides these patients with new pressure-optimized custom-made footwear specifically for indoors, and assesses their effect on footwear adherence inside the house.
For many people with loss of protective sensation in the feet, due to diabetes or another cause, wearing custom-made footwear that offloads the pressure of vulnerable tissue is paramount to prevent chronic foot wounds (ulcers). However, these shoes are often not worn indoors for various reasons (e.g. heavy, difficult to put on and take off, dirty, habit).
To overcome this problem, we developed a custom-made shoe specially for use in the home environment. In a randomized controlled trial, the effects of providing these house shoes are measured on the use of footwear (adherence), quality of life, costs and the incidence/recurrence of ulcers. The study focuses on people with diabetes at medium-to-high risk of foot ulcers, as well as on people without diabetes at high risk of foot ulcers.
Participants will be followed for a total of 12 months. The intervention and its results will be compared with the current standard care. The research expects to show that the provision of custom-made house shoes increases adherence indoors substantially, which means that the feet are better protected against ulceration throughout the day. This contributes to the prevention of ulcers and thus the quality of life of the included patient groups.