Off­loading the diabetic foot

Background of the study:

Diabetes Mellitus (DM) is one of the most common chronic diseases. In these patients chronic non-healing ulcers of the foot are a significant problem. The first line of treatment consists of offloading these ulcers to reduce (peak) pressure at the ulcer location. Casting devices such as the total contact cast (TCC), bivalved TCC, or cast shoes are commonly used offloading treatment devices. However, the effect of these devices on the plantar peak pressure has not been directly investigated with between­-device variability of the plantar sole controlled.

Objective of the study:

To assess the efficacy of a TCC, a BTCC and a cast shoe with similar plantar soles on offloading the previous ulcer location in people with DM and peripheral neuropathy.
Primary objective: a comparison between a TCC, BTCC and a cast shoe, all with a Solo vinyl cast sole.

Secondary objectives: a comparison between a cast shoe and a non-modelled cast shoe, both with a Solo vinyl cast sole, and a comparison between a cast shoe with a Solo vinyl cast sole and a cast shoe with a Cellona sole.



Study design:

Intervention study with a within­-subject design, with one measurement session.



Study population:

Minimal 16 people with diabetes mellitus, peripheral neuropathy and a healed foot ulcer will be measured in all conditions.

Casting devices such as the total contact cast (TCC), bivalved TCC, or cast shoes are commonly used offloading treatment devices. The effect of these devices on the plantar peak pressure has not been directly investigated with between-­device variability of the plantar sole controlled.



From this within-­subject comparison, we can improve our understanding of the mechanisms used in offloading the diabetic foot, which may contribute to our understanding of the relation between offloading devices and healing of diabetic foot ulcers.

During one measurement session the dynamic in-shoe plantar peak pressure and force-time integral will be measured with the Pedar-X system (Novel GmbH, Munich, Germany). The perceived walking comfort will be assessed after completion of data collection in each offloading device using a visual analogue scale (VAS) with outcome score ranging from 0 (very uncomfortable) to 10 (very comfortable).

Total contact cast

Bivalved total contact cast

Cast shoe

Non-modelled cast shoe

Cast shoe with Cellona sole