Article title

State of the art design protocol for custom made footwear for people with diabetes and peripheral neuropathy.

(Bus, S. A., Zwaferink, J. B., Dahmen, R., & Busch-Westbroek, T.)

Journal

Diabetes/metabolism research and reviews

Issue/Page No:

36 Suppl 1(Suppl 1), e3237

Discussion date

Wednesday 6^th December 2023

Study objectives, hypothesis and question?

The study “aimed to develop a design protocol to support custom-made footwear prescription for people with diabetes and peripheral neuropathy.”

Target population: “people with diabetes who are at moderate-to-high risk of developing a foot ulcer, for whom custom-made footwear (shoes and/or insoles) can be prescribed.”

Discussion: Podiatrist and pedorthist colleague AJ shared that this protocol has been well received at the recent Pedorthic Association of Australia (PAA) Conference 2023 in Fremantle where the one of the authors (Sicco A. Bus) was the keynote speaker. This protocol is making an impact on the work of the profession. Prior to this, Rutger Dahmen’s work was the ‘gold standard’.

Rationale and relevance of the question? (why was the study done?)

Rationale for this protocol is to help guide the workforce. Protocol is required to assist with clear and clinical decision‐making in selecting the type of footwear. Currently there is minimal published protocol, shoe concept or algorithm. Prior to this paper, there have been only two consensus‐based algorithms for custom‐made footwear and a pressure‐ and foot shape‐guided design algorithm for custom‐made insoles identified in the scientific literature.

Relevance of this topic/question to Podiatrists?

All discussed that the protocol is relevant, essential, and useful to pedorthist, orthotist and podiatrist. For pedorthist, it will further guide practice, creation and manufacturing of footwear. There are no existing guidelines or standardised approach currently in place to make footwear and boots. Concerns about how to disseminate the study and guidelines were discussed.

For podiatrist, this protocol will enhance knowledge to better provide patient centred care for patients. The protocol will assist podiatrist to educate patients on the footwear requirements as well as facilitating the referral of the patient to a pedorthist and working collaboratively with the pedorthist.

Discussion: It is important for podiatrists to understand the design criteria of a footwear for a high risk patients and assist to support pedorthist to send the same message to the patient. For example, should a patient complain about the prescribed footwear being too chunky or too bulky, the podiatrist can assist to reiterate the reasons for the features of the footwear.

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.

Discussion:

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.

What were the results of the study? (what did the investigators find?)

A design protocol for custom‐made footwear for the moderate‐to‐high‐risk patient with diabetes and peripheral neuropathy was developed.

Strengthens and weaknesses of this study? Are the results valid? Look at study design and the appropriateness of the method(s), population and sample size, appropriate study conduct, data gathering, subject follow-up, influences of bias, methods of analysis, discussion, current and comprehensive listed references).

Strengths: Robust study and expert panel came to a consensus.

The pressure‐relief design algorithm consisted of 10 required steps for the design of custom‐made footwear.

Weaknesses: Expert panel did not include experts such as rehabilitation physicians, orthopaedic surgeons, podiatrist

Do the conclusions follow logically from the design and results?

Yes

How do the results relate to current practice and how might they influence future practice? (what does the answer mean anyway? So what? Who cares?)

The protocol is a valuable resource for pedorthist as there are nil consensus prior to this. However, the concern is around the availability of skilled pedorthist who can implement this protocol and the cost to patients. Pedorthists may have limited clinical skills set and confidence to implement the protocol. In Australia, funding for patients for footwear needs to increase. Patient adherence was also a concern (“Will patient wear it?”). Suggestions that a protocol should be established for Australia to consider the many barriers to implementing the protocol e.g.  the hot climate, cost, funding system.

Conclusion that the protocol is useful however we may find that it may be difficult to translate the algorithms to practice in Australia.