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.

Article Title:

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

Journal:

Wound Repair & Regeneration: official publication of the Wound Healing Society and the European Tissue Repair Society 2019,

Issue/Page No:

27(5)

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

Limitations:

• Small sample size
• More type 1 participants
• No indigenous or immigrant participants
• Testing hypothesis rather than finding new research
• Did not encapsulate the whole population or cohort of DFU
• Applicable to those with neuropathy only
• Small sample
• Possible bias – patient going from HRF appt to interview straight away. Re-discussion of results in the interview -.
• Interview environment could have influence
• Smart phone use, population younger, possibly wealthier, intellectually more advanced, cognition, higher socioeconomic group?? Tech savvy.
• No formal assessment of health literacy – known for patients with DFU early dementia.
• Dialysis patients have poor retention of information post dialysis with education – multiple research sources
• Not generalisable limitations with population sample -potential for future research.
• Not fresh minds participants from another study, possible bias with potential convenience.
• Those that participate in research tend to be more engaged, likely to be more likely to follow education. Possible bias, higher health literacy.
• Gaps in methods not discussed but clarification with Jaap the investigators were different to the clinicians.
• Chronicity of the wounds would be interesting to explore, may influenced patient perception.
• Those wearing TCC vs removable devices answers would be different from interview.

Strengths

• WHO framework identified – part of the theme of the paper and 5 point framework. Qualitative commentary is still valid. Points to think in own practice.
• Learning points: new app for qualitative data app (www.saturateapp.com)

Do the conclusions follow logically from the design and results?

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.

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

Study objective, hypothesis and question?

The median TCC duration for the resolution of an acute Charcot foot in Australia. Exploring clinical factors.

Rationale and relevance of the question?

(Why was the study done?)

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.

Relevance of this topic/question to FH Podiatrists?

(Is it urgent or essential reading for a podiatrist working in an acute hospital?

•         Podiatrists are not able to provide guidance on time-frames in TCC treatment length. This study is relevant to set patient expectations and providing informed consent for treatment. It also assists patients with organising social supports, finances and work.
•        There is varying data in duration around the world.
•         It is important to gather Australian data for Australian podiatrists and patients.
•         Highly relevant to HRF podiatrists in acute and community
•        The study also highlights the high number of misdiagnosed patients when signs and symptoms first appeared.

What methodological approach (design, analysis, etc.) has been used?

(RCT, Case control, case study series, meta analysis etc.)

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.

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

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.

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

Strengths:

•         Robust screening and strict criteria, study is easily repeated.
•         Strengths in identifying risks in TCC treatment were only minor skin rubbing and irritation. 
•         Findings were generalisable to those with diabetes and peripheral neuropathy, therefore applicable to similar patients.
•         Realistic representation of the population – patients were not using assistive ambulating devices (crutches, walkers, knee scooters) and continuing daily activities of living whilst receiving treatment.

Weakness:

•         Time that patients were out of the TCC treatment was still included in the treatment time. However, this was justified by the patient only spending 1 week out of a TCC for flying and were in appropriate offloading such as a removable walker.
•         Osteoarthritis prevalence could be in any joint.
•         The osteoarthritis was not measurable via imaging before or after, it was dependent on medical history
•    Study did report that the increase in osteoarthritis was difficult to be explained, but maybe from biomechanical factors
•          Small sample size
•          Retrospective study – medical documentation flaws
•          External factors that can influence TCC duration length
•          Medical specialty led clinics
•          Experienced/trained clinician in identifying Charcot foot status

Do the conclusions follow logically from the design and results?

Yes, duration of TCC treatment is shorter or comparable to data reported in the UK, US, Europe and Asia Pacific countries.

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 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, hypothesis and question?

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.

Rationale and relevance of the question?

(Why was the study done?)

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?

Relevance of this topic/question to FH Podiatrists?

(Is it urgent or essential reading for a podiatrist working in an acute hospital?

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.

What methodological approach (design, analysis, etc.) has been used?

(RCT, Case control, case study series, meta analysis etc.)

Methodological approach used: observational cross-sectional study which was the most pragmatic design based on the resources available.

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

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. 

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

Strengths

• -        The amount of data collected was substantial.

 Weakness

• -        Cross-sectional design means it is not possible to draw conclusions regarding causality.
• -        Logistical constrains meant that 111 participants were recruited instead of 200 participants (100 per group) as initially planned which may have contributed to a type 2 error.
• -        Recruitment from a hospital outpatient clinic may limit the generalisability of findings.
• -        Assessment of foot self-care relied on self-reporting allowing room for the possibility of recall and social desirability bias.
• -        Patients better matched with comorbidities in this study, and have common pathways regarding diabetes.
• -        No longitudinal data was assessed. The prognostic impact of any impact of any differences between cohorts could not be investigated.

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?)

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.