What methodological approach (design, analysis, etc). has been used? (RCT, Case control, case study series, meta-analysis etc).
A design protocol for custom‐made footwear for the moderate‐to‐high‐risk patient with diabetes and peripheral neuropathy was developed.
2 algorithms: 1) The pressure‐relief algorithm and 2) the footwear design and pressure‐relief algorithms.
Method involved convening a group of experts including experts from rehabilitation medicine, orthopaedic shoe technology (pedorthics) and diabetic foot research. Meetings occurred over 2 hours for 12 sessions.
Table 1 included 14 domains of foot pathology were defined. This included comprehensive details of the domain categorised into direct scientific evidence, in-direct scientific evidence and consensus working group.
Table 2 demonstrates the pressure‐relief design algorithm, consisting of 10 required steps for design.
Table 1- Interesting to see that Charcot midfoot deformity was included as in practice, this deformity is commonly addressed with off the shelf devices.
Table 2- Good to see the cost benefit for the patient was included as specialised footwear can be very costly to patients. F-scan and Pedar system are expensive. Sensors are approx. $150 short arm and $250 for long arm sensors. Sensors are reusable but unlikely that it as effective as new sensors.
If cost benefit analysis is conducted is considered, the cost of expensive footwear that can cost up to $6000 is still effective compared to amputation costs.
Pedorthist may find it difficult to adhere to the protocol due to the cost. Funding schemes may not fully covert the cost for patients and patients will unlikely be able to afford the footwear.
Pedorthist may need to compromise certain features of a shoe in this scenario. E.g. Off the shelf footwear may be used instead costing
$400-500. Cost is mainly from the labour.
It is likely that 3D printing is used in this space however 3D printing can still be time consuming and may not bring down the cost at this present time. Pedorthist are choosing to outsource to other countries such as Bangladesh and Philippines.