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.)
Diabetes/metabolism research and reviews
36 Suppl 1(Suppl 1), e3237
Wednesday 6th 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.
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?)
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?
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.
Reasons for (non-)adherence to self-care in people with a diabetic foot ulcer
Jaap J van Netten, Leonard Seng, Peter A Lazzarini, Jason Warnock, Bernd Ploderer
Wound Repair & Regeneration: official publication of the Wound Healing Society and the European Tissue Repair Society 2019,
Discussion Date: 23 / 2 / 2023
Study objective, hypothesis and question?
Qualitative, hypothesis generating study exploring.
Interview style performed
Rationale and relevance of the question?
(Why was the study done?)
DFU self-care lack of evidence, explore intervention self-care activities to
Respect self-care and no foot ulcers. But in this space limited.
Relevant area of research, majority of care is seen outside of the clinical setting. Time factor, limiting impact. Most of the work is done outside of the clinical setting for the patient. What goals patients have and identifying barriers is essential
Self-care with risk of ulceration vs those with active ulcerations would be different.
Relevance of this topic/question to FH Podiatrists?
(Is it urgent or essential reading for a podiatrist working in an acute hospital?
Essential for any podiatrist to consider with patient presenting with HRF wound. Enlightening, exploring the issues with the patient around integrating offloading into their day. Valued part of the treatment. Limitations with available offloading (cumbersome, knee to ankle height offloading), environmental and life style barriers to wear devices. Short changing people with delivering in-effective education, aligning patient goals with therapeutic goals. Limitations with time in clinic, not necessarily seeing patient often enough to enforce the importance of therapeutic goals. What is their understanding of the therapeutic goals? Often patient confusion, not necessarily aware of the objectives of care.
Patient understanding of information supplied, what we communicate is essential, this may be interpreted differently. Motivation of the patient in this article was key to adherence
No indigenous or immigrant community included, barriers and issues maybe different or similar to general population?
Relevance is identified, duration of working in HRF and noting that education is important and how it is interpreted by the patients.
What methodological approach (design, analysis, etc.) has been used?
(RCT, Case control, case study series, meta analysis etc.)
A qualitative study using face-to-face semi-structured interviews, using the framework approach.
A 40-item, semi-structured interview guide was developed. The systematic nature of the framework approach allowed for the interview guide to be structured to align with the various aspects and factors of diabetic foot ulcer self-care.
Interview guide was piloted with two persons not included in the study, to ensure validity and feasibility.
5 key threads to that approach – interview
Familiarisation, Thematic framework identification, indexing, charting, mapping and interpreting data.
WHO adherence dimensions (social and economic factors; therapy-related factors; patient-related factors; health-system related factors; condition-related factors
Bias with study design,
-interview was completed after the appointment.
-not clear if patients were questioned by same person.
Missing methods information
Themes and interpretations were discussed
Smart phone use - may exclude some relevant participants.
What were the results of the study? (What did the investigators find?)
Multi-dimensional factors that contribute to non-adherence.
Nothing new, that self-care is not well done. Didn’t look at the communication or education provided by the practitioner.
Patient explored the adherence at home only. Many factors, in education.
Research location (South East Queensland) may not have full relevance to the general population.
Further research proposing possible solutions to these issues with self-care rather than providing a reflective element to the study conclusion.
Strengths & weaknesses of this study? Are the results valid? Look at study design, appropriateness of the method(s), population and sample size, appropriate study conduct, data gathering, subject follow‐up, influences of bias, methods of analysis, discussion, currentness and comprehensiveness of the listed references
Yes, null hypothesis that difficulty in self care was going to be an issue. It reaffirms what we know, how do we address this in practice.
Apply this study to a wider cohort – difficulty in the qualitative design
Not assuming patients have any knowledge – care needs to be explicitly explained, clinical environment and time can influence effectiveness.
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?)
What we confirm and all believe and know, there are barriers and themes that need to be addressed with education and self-care.
Teaching and communication – we don’t recognise or research well, how well do we communicate to our patients?
Clinicians often assume that they communicate consistently with a valid and reliable outcome.
NESB/. Indigenous population and other populations can be impacted when the message does not get across. Repetition isn’t always effective communication. Patient can reach a point of saturation.
Outcomes from communication – need to be explored and the styles of communication/education used clinically.
Qualitative study and question around possible bias environment and when clients were interviewed?
-Researchers were interviewers, early research career person and a non podiatric / no DFU experience colleague.
Japp not one of the interviewers
Qualitative research you will always have an element of bias with questioning. Early career researcher, structure was useful and controlling research design. Actively caring for the patient may influence patient.
Stranger may open up more.
Possible bias controlled and other variable with relatively structured approach to interview questions, researcher early in research career.
-Interview was completed in clinic room? Would it have made a difference, time, space between appointment?
Environment was considered with study design – patient home vs clinical space. Awareness of influence on question outcomes.
Awareness that participants were happy to identify barriers to self-care. Jaap didn’t feel this influenced the conclusions from the study. Current study is not generalisable, but still adds to the research pool.
Future research opportunity different population sample, further focus on themes already identified from WHO framework and current study conclusions. Negative patient may seek opportunity to complain to an outside researcher, could influence conclusions in qualitative research
Interview vs focus group – structured interview slightly better, where focus groups the researcher has to manage patient interaction and note where conversation may go. Interaction was missed with patients which is prevalent in focus group. Questions were used during current study with ‘other patients have experienced X…..” await outcome from participant.
Where do we go from here?
Does this open up for further research to be conducted here?
Clinical day and time can influence outcomes and education delivered.
The invisible balls that patients are constantly juggling with their health care. How do we incorporate education and self-care focus into our practice. Not more checklists, already heavy administrative burden with a questionnaire or check list, more of an awareness and working more collaboratively. Difficult.
Interactions with people assumptions that you carry – insightful and people’s motivation. Aligning patient goals with therapeutic goals vs therapeutic goals aligning with patient goals. Holistic care. Staged approach to include more therapeutic care goals at each appointment.
Sample size small
Article Title: Duration of total contact casting for resolution of acute Charcot foot: a retrospective cohort study
Journal: Journal of Foot and Ankle Research
Issue/Page No: 14:44 1-12
Discussion Date: 20/7/2022
The median TCC duration for the resolution of an acute Charcot foot in Australia. Exploring clinical factors.
There was varying TCC treatment lengths in different countries and limited Australian data in regards to the duration of TCC treatment.
Study was done to present more Australian data and identify any clinical factors affecting its duration.
Retrospective cohort study over a 3 years period. The cohort was from a large metropolitan hospital.
The study group was small consisting of 27 participants.
The study’s eligibility criteria were strict where current ulcers were excluded from the study.
The study showed a median of 4.3 months of treatment time in TCC.
Patients diagnosed with osteoarthritis before they had an active Charcot’s foot showed a TCC treatment time-frame of more than 4 months - had more incidents of osteoarthritis (in any joint) post treatment.
Identified a high misdiagnosis of Charcot’s foot before attending the high risk foot service.
The greatest reduction in temperature was at the affected Charcot site.
Yes, duration of TCC treatment is shorter or comparable to data reported in the UK, US, Europe and Asia Pacific countries.
The study supports change in podiatry practice by giving podiatrists the ability to provide better informed consent and education for TCC treatment.
Ability to estimate time-frames and setting expectations.
Advising patients of risk factors.
Article Title: Evaluating Cognitive Impairment in People with Diabetes-Related Foot Ulceration
Journal: Journal of Clinical Medicine
Issue/Page No: 2021, 10 (13)
Discussion Date: 03/03/2022
Study Objective: To determine whether there is an excess of cognitive impairment in patients with T2DM and foot ulceration.
Hypothesis Question: Whether DFUs in people with T2DM is associated with greater cognitive impairment, compared with T2DM without DFU.
Patients with a Diabetic Foot Ulcer often do not complete what is required to manage their DFU. Is there some Cognitive Impairment in patients with a Diabetic Foot Ulcer that impedes ability to carry out what’s required to manage DFU?
Should tools be used to assess/explore cognitive impairment to improve patient education and patient outcomes?
Highly relevant across all HRFS.
Patients provided with instructions and information, yet are unable to complete instructions.
Essential reading for podiatrists working in HRFS/with patients presenting with DFUs.
Methodological approach used: observational cross-sectional study which was the most pragmatic design based on the resources available.
No difference found between the two groups assessed regarding cognitive scores. The study did not show an excess of cognitive impairment in patients with T2DM and DFU compared with patients with T2DM and no DFU.
50% of participants across both groups had mild cognitive impairment.
Prior studies conducted and compared results between population with T2DM and DFUs vs no diabetes – Found disparity between co-morbidities, potentially influencing causation and pathway for cognitive impairment.
Future research is needed to establish whether cognitive impairment impacts DFU healing/LEA outcomes.
Detailed assessment of self-care behaviour currently under review, not yet published.
Non-adherence and adverse DFU outcomes may potentially be driven by other factors such as behavioural aspects, personality constructs, social disadvantage, education aspects, work commitments, family commitments, health literacy impacting self-care behaviour.
Clinicians need to adjust how patient education is delivered to this vulnerable cohort of patients who have challenges regarding memory and retention – Change delivery of education to be succinct and clear, being mindful of prevalence in patient cohort.
Improved access to Health Psychology within a High-Risk Foot Service is required to improve outcomes for patients.