The financial burden of diabetes-related foot disease in Australia: a systematic review.

BACKGROUND: Diabetes-related foot disease (DFD) is a common, costly, and severe complication of diabetes mellitus. DFD is associated with high rates of morbidity and mortality and poses a significant burden on patients, healthcare systems and society. While the detrimental impact of DFD is widely recognised, the precise financial implications of its management in Australia remain unclear due to inconsistent and inconclusive contemporary data. Therefore, the aim of this review was to identify, summarise and synthesise existing evidence to estimate the costs associated with DFD management in Australia. METHODS: Searches were conducted in MEDLINE, Embase, AMED, CINAHL, Joanna Briggs Institute EBP, and the Cochrane Library from November 2011 to July 2023. Australian studies investigating costs associated with DFD management were eligible for inclusion. Two independent reviewers performed the study selection, data extraction and quality assessment steps. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022) checklist was used to assess study quality. A descriptive analysis was performed due to limited existing evidence and large heterogeneity between study populations to conduct meta-analyses. RESULTS: Three economic evaluations were included in the review. One study was rated as 'poor', one as 'very good' and one as 'excellent' when assessed against the CHEERS checklist. The estimated cost of DFD management varied between studies and comparisons were not possible due to the different methodological approaches and data sources. The studies were unable to provide an overall cost of DFD with respect to all aspects of care as they did not capture the multi-faceted level of care throughout the entire patient journey between sectors and over time. CONCLUSION: There is limited contemporary evidence for the costs associated with DFD management within Australia, particularly related to direct costs and resource utilisation. Further research into the economic impact of DFD management is needed to inform optimisation of national service delivery and improve health outcomes for individuals with DFD in Australia. Integrating real-world data on impact of clinical interventions with parallel economic evaluation could be a valuable approach for future research, which would offer a more comprehensive understanding of the clinical and economic outcomes beyond solely model-based evaluations. TRIAL REGISTRATION: PROSPERO Registration No. CRD42022290910.

Psychological factors associated with foot and ankle pain: a mixed methods systematic review.

BACKGROUND: Foot and ankle pain is common, and generally viewed through a biomedical lens rather than applying a biopsychosocial model. The objectives of this review were to evaluate: (1) the psychosocial characteristics of participants with foot/ankle pain compared to participants without foot/ankle pain; (2) the association between psychosocial factors with pain and function in people with foot/ankle pain; and (3) understand the psychosocial factors associated with the lived experience of foot/ankle pain. METHODS: A mixed methods systematic review was conducted according to the PRISMA guidelines and guided by the Joanna Briggs Institute methodology for mixed methods systematic reviews. The databases MEDLINE, Embase, CINAHL, SPORTDiscus, PsychInfo, and Scopus were searched. The Mixed Methods Assessment Tool was used to evaluate study quality. A convergent segregated approach was used to synthesise and integrate quantitative and qualitative data. RESULTS: Eighteen studies were included, consisting of 13 quantitative, 4 qualitative and 1 mixed methods study. The overall quality of the studies was considered high. Integration of the quantitative and qualitative data were not possible due to the disparate nature of the included studies. A narrative synthesis of the quantitative data revealed that negative emotional and cognitive factors were more common in people with foot/ankle pain compared to those without foot/ankle pain. A significant association was also found between emotional distress with foot pain and foot function in some people with plantar heel pain. In addition, kinesiophobia and pain catastrophising were significantly associated with impaired foot function, and pain catastrophising was significantly associated with first step pain in people with plantar heel pain. The qualitative data revealed emotional impacts, physical challenges, and a loss of self which was individual and unpredictable. CONCLUSIONS: This review provides evidence that negative psychological constructs are greater in participants with foot/ankle pain compared to those without foot/ankle pain, although the cross-sectional nature of the study designs included in this review reduces the certainty of the evidence. These findings indicate that psychological constructs are associated with foot/ankle pain. Further research should evaluate the predictive ability of multidimensional screening tools to identify patients at risk of developing persistent foot/ankle pain.

Podiatrists' views of assessment and management of pain in diabetes-related foot ulcers: a focus group study.

BACKGROUND: Contrary to the belief that patients with diabetes-related foot ulcers (DRFU) do not experience wound related pain due to the presence of peripheral neuropathy there is increasing evidence that pain can be present. Subsequently, wound-related pain is often underestimated and undertreated. The aim of this study is to describe what influences pain assessment of DRFU. METHODS: A qualitative exploratory study was conducted with podiatrists who managed DRFU. Eight podiatrists were recruited through a professional organisation to participate in a focus group. A thematic analysis was conducted to identify themes that explored the barriers and enablers to pain assessment and management of DRFU. RESULTS: Three themes emerged. Observational and non-verbal cues were the preferred approaches used to assess wound pain. Assumptions and value judgments of the pain patients experienced and the relationships between podiatrists, patients and other health care practitioners were important influencers on the assessment and management of pain. CONCLUSION: The perceived barriers to the assessment and management of wound related pain in DRFU were attitudes and beliefs about pain, lack of DRFU-specific validated assessment tools and lack of knowledge and skills to manage the pain.

Assessment of pain in chronic wounds: A survey of Australian health care practitioners.

Pain associated with chronic wounds can delay wound healing, affects quality of life, and has a major impact on physical, emotional, and cognitive function. However, wound-related pain is often under-assessed and may therefore be suboptimally managed. The aim of this study was to describe the assessment practices used to assess chronic wound pain by health practitioners in Australia. A structured self-administered questionnaire was posted to members of an Australian national wound care organisation, whose membership represents various health practitioners involved in wound management. A total of 1190 (53%) members completed the survey. Overall, wound pain assessment was most commonly conducted at every consultation or wound dressing change (n = 718/1173, 61%). Nurses were more likely to assess wound-related pain before, during, and after the wound dressing procedures compared with other health care practitioners. In contrast, podiatrists assessed wound pain only when the patient complained about the pain. The most common assessment method was simply talking to the patient (n = 1005/1180, 85%). Two-thirds of practitioners used a validated pain assessment tool. The most commonly used tool was the numerical analogue scale (n = 524/1175, 46%). In summary, these findings suggest that there is no consistent method for the assessment of wound-related pain, and there are substantial variations in how and when wound-related pain is assessed between different professions.

Reliability of a Skin Diagnostic Device in Assessing Hydration and Erythema.

OBJECTIVE: To examine the reliability of a skin diagnostic device, the SD202 (Courage+Khazaka GmBH, Cologne, Germany), in assessing hydration and erythema of periwound skin and pressure injury-prone areas. DESIGN: Intrarater reliabilities from 3 cross-sectional and prospective studies are reported. SETTING AND PARTICIPANTS: Patients attending an outpatient, nurse-led wound dressing clinic (n = 16), a podiatrist-led high-risk foot clinic (n = 17), and residents (n = 38) at a single residential aged-care facility. MAIN OUTCOME MEASURE: Skin hydration and erythema levels assessed using the SD202. MAIN RESULTS: High internal consistency was maintained for consecutive skin hydration and erythema measures at a single point on the venous leg ulcer periwound (α > .996 and α > .970 for hydration and erythema, respectively) and for the pressure-prone areas of the sacrum (α > .916), right (α > .994) and left (α > .967) ischium, right (α > .989) and left (α > .916) trochanter, right (α > .985) and left (α > .992) calcaneus, and right (α > .991) and left (α > .990) lateral malleolus. High consistency was also found for the measures obtained at 4 different locations around the periwound for the venous leg ulcer (α > .935 and α > .870 for hydration and erythema, respectively). In diabetic foot ulcer assessment, acceptable internal consistency of hydration measures around the periwound was observed (α > .634). Internal consistency of erythema measures was variable, ranging from low to high reliability, particularly among predebridement measures. CONCLUSIONS: Using the protocols outlined in this study, the SD202 demonstrates high reliability for assessing skin hydration and erythema levels. It is possible that the SD202 can be used in clinical practice as an appropriate tool for skin hydration and erythema assessment.

Effectiveness of off-the-shelf, extra-depth footwear in reducing foot pain in older people: a randomized controlled trial.

BACKGROUND: Foot pain is highly prevalent in older people and in many cases is associated with inappropriate footwear. This study evaluated the effectiveness of off-the-shelf, extra-depth footwear in reducing foot pain. METHODS: Community-dwelling older people with disabling foot pain (72 men and 48 women aged 65 to 96 years; mean age 82 [SD 8]) were randomly allocated to an intervention group (n = 59) or control group (n = 61). The intervention group was provided with off-the-shelf, extra-depth footwear. Participants in the control group received their footwear at the completion of the study. Both groups continued to receive usual podiatry care for the study period. The primary outcome measure was the Foot Health Status Questionnaire (FHSQ), measured at baseline and 16 weeks. RESULTS: There was a significant improvement in the FHSQ pain domain (ANCOVA-adjusted mean difference 11.5 points, 95% confidence interval 4.2 to 18.8, p = .002) and FHSQ function domain (10.0 points, 0.9 to 19.1, p = .032) in the intervention group compared to the control group. The intervention group also developed fewer keratotic lesions (mean difference -1.4, -2.5 to -0.2, p = .021), were less likely to report the use of co-interventions (relative risk [RR] 0.74, 0.56 to 0.98, p = .026) and were more likely to report that their foot pain had moderately or markedly improved during the study (RR = 7.93, 2.51 to 25.00, p < .001; number needed to treat = 3, 2 to 5). CONCLUSIONS: Off-the-shelf, extra-depth footwear significantly reduces foot pain, improves foot function and is associated with the development of fewer keratotic lesions in older people.

Comparison of the responsiveness of the foot health status questionnaire and the Manchester foot pain and disability index in older people.

BACKGROUND: In recent years, several questionnaires have been developed for the assessment of foot health and its impact on quality of life. In order for these tools to be useful outcome measures in clinical trials, their ability to detect change over time (responsiveness) needs to be determined. Therefore, the aim of this study was to assess the responsiveness of two commonly-used questionnaires in older people with foot pain. METHODS: Participants (n = 59; 24 women and 35 men, mean age [SD] 82.3 [7.8] years) allocated to the intervention arm of a randomised controlled trial assessing the effectiveness of extra-depth footwear compared to usual care completed the Foot Health Status Questionnaire (FHSQ) and Manchester Foot Pain and Disability Index (MFPDI) at baseline and 16 weeks. Responsiveness of the FHSQ subscales (pain, function, footwear and general foot health) and MFPDI subscales (pain, functional limitation and concern about appearance) was determined using (i) paired t-tests, (ii) Cohen's d, (iii) the standardised response mean (SRM), and (iv) the Guyatt index. RESULTS: Overall, the FHSQ pain subscale exhibited the highest responsiveness, as evidenced by a highly significant paired t-test (p <0.001), Cohen's d = 0.63 (medium effect size), SRM = 0.50 (medium effect size) and Guyatt index = 1.70 (huge effect size). The next most responsive measure was the FHSQ function subscale, as evidenced by a borderline paired t-test (p = 0.050), Cohen's d = 0.37 (small effect size), SRM = 0.26 (small effect size) and GI = 1.22 (very large effect size). The FHSQ footwear, FHSQ general foot health and MFPDI pain, functional limitation and concern about appearance subscales demonstrated lower responsiveness, with negligible to medium effect sizes. CONCLUSION: The FHSQ pain and function subscales were most responsive to change in older people with foot pain receiving a footwear intervention. These findings provide useful information to guide researchers in selecting appropriate outcome measures for use in future clinical trials of foot disorders.

Evaluation of the accuracy of shoe fitting in older people using three-dimensional foot scanning.

BACKGROUND: Ill-fitting footwear is a common problem in older people. The objective of this study was to determine the accuracy of shoe fitting in older people by comparing the dimensions of allocated shoes to foot dimensions obtained with a three-dimensional (3D) scanner. METHODS: The shoe sizes of 56 older people were determined with the Brannock device®, and weightbearing foot scans were obtained with the FotoScan 3D scanner (Precision 3D Ltd, Weston-super-mare, UK). Participants were provided with a pair of shoes (Dr Comfort®, Vista, CA, USA), available in three width fittings (medium, wide and extra wide). The dimensions (length, ball width and ball girth) of the allocated shoes were documented according to the last measurements provided by the manufacturer. Mean differences between last dimensions and foot dimensions obtained with the 3D scanner were calculated to provide an indication of shoe fitting accuracy. Participants were also asked to report their perception of shoe fit and comfort, using 100 mm visual analogue scales (VAS). RESULTS: Shoe size ranged from US size 7 to 14 for men and 5.5 to 11 for women. The allocated shoes were significantly longer than the foot (mean 23.6 mm, 95% confidence interval [CI] 22.1 to 25.2; t55 = 30.3, p < 0.001), however there were no significant differences in relation to ball width (mean 1.4 mm, 95% CI -0.1 to 2.9 mm; t55 = 1.9, p = 0.066) or ball girth (mean -0.7 mm, 95% CI -6.1 to 4.8 mm; t55 = -0.2, p = 0.810). Participants reported favourable perceptions of shoe fit (mean VAS = 90.7 mm, 95% CI 88.4 to 93.1 mm) and comfort (mean VAS = 88.4 mm, 95% CI 85.0 to 91.8 mm). CONCLUSION: Shoe size selection using the Brannock device® resulted in the allocation of shoes with last dimensions that were well matched to the dimensions of the foot. Participants also considered the shoes to be well fitted and comfortable. Older people with disabling foot pain can therefore be dispensed with appropriately-fitted shoes using this technique, provided that the style and materials used are suitable and extra width fittings are available.

Effectiveness of off-the-shelf footwear in reducing foot pain in Australian Department of Veterans' Affairs recipients not eligible for medical grade footwear: study protocol for a randomized controlled trial.

BACKGROUND: Foot pain is highly prevalent in older people, and in many cases is associated with wearing inadequate footwear. In Australia, the Department of Veterans' Affairs (DVA) covers the costs of medical grade footwear for veterans who have severe foot deformity. However, there is a high demand for footwear by veterans with foot pain who do not meet this eligibility criterion. Therefore, this article describes the design of a randomized controlled trial to evaluate the effectiveness of low cost, off-the-shelf footwear in reducing foot pain in DVA recipients who are currently not eligible for medical grade footwear. METHODS: One hundred and twenty DVA clients with disabling foot pain residing in Melbourne, Australia, who are not eligible for medical grade footwear will be recruited from the DVA database, and will be randomly allocated to an intervention group or a 'usual care' control group. The intervention group will continue to receive their usual DVA-subsidized podiatry care in addition to being provided with low-cost, supportive footwear (Dr Comfort®, Vasyli Medical, Labrador, Queensland, Australia). The control group will also continue to receive DVA-subsidized podiatry care, but will not be provided with the footwear until the completion of the study. The primary outcome measure will be pain subscale on the Foot Health Status Questionnaire (FHSQ), measured at baseline and 4, 8, 12 and 16 weeks. Secondary outcome measures measured at baseline and 16 weeks will include the function subscale of the FHSQ, the Manchester Foot Pain and Disability Index, the number of DVA podiatry treatments required during the study period, general health-related quality of life (using the Short Form 12® Version 2.0), the number of falls experienced during the follow-up period, the Timed Up and Go test, the presence of hyperkeratotic lesions (corns and calluses), the number of participants using co-interventions to relieve foot pain, and participants' perception of overall treatment effect. Data will be analyzed using the intention-to-treat principle. DISCUSSION: This study is the first randomized controlled trial to evaluate the effectiveness of off-the-shelf footwear in reducing foot pain in DVA recipients. The intervention has been pragmatically designed to ensure that the study findings can be implemented into policy and clinical practice if found to be effective. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12612000322831.

A survey of foot problems in community-dwelling older Greek Australians.

BACKGROUND: Foot problems are common in older people and are associated with impaired mobility and quality of life. However, the characteristics of foot problems in older Australians for whom English is a second language have not been evaluated. METHODS: One hundred and four community-dwelling people aged 64 to 90 years with disabling foot pain (according to the case definition of the Manchester Foot Pain and Disability Index, or MFPDI) were recruited from four Greek elderly citizens clubs in Melbourne, Australia. All participants completed a Greek language questionnaire consisting of general medical history, the Medical Outcomes Study Short-Form 36 (SF-36) questionnaire, the MFPDI, and specific questions relating to foot problems and podiatry service utilisation. In addition, all participants underwent a brief clinical foot assessment. RESULTS: The MFPDI score ranged from 1 to 30 (median 14), out of a total possible score of 34. Women had significantly higher total MFPDI scores and MFPDI subscale scores. The MFPDI total score and subscale scores were significantly associated with most of the SF-36 subscale scores. The most commonly reported foot problem was difficulty finding comfortable shoes (38%), and the most commonly observed foot problem was the presence of hyperkeratotic lesions (29%). Only 13% of participants were currently receiving podiatry treatment, and 40% stated that they required more help looking after their feet. Those who reported difficulty finding comfortable shoes were more likely to be female, and those who required more help looking after their feet were more likely to be living alone and have osteoarthritis in their knees or back. CONCLUSIONS: Foot problems appear to be common in older Greek Australians, have a greater impact on women, and are associated with reduced health-related quality of life. These findings are broadly similar to previous studies in English-speaking older people in Australia. However, only a small proportion of this sample was currently receiving podiatry treatment, and a substantial number stated that they required more help looking after their feet. To address this issue, steps need to be taken to increase awareness of podiatry services among older Greek Australians.

Development and validation of a Greek language version of the Manchester Foot Pain and Disability Index.

BACKGROUND: The Manchester Foot Pain and Disability Index (MFPDI) is a 19 item questionnaire used to assess the severity and impact of foot pain. The aim of this study was to develop a Greek-language version of the MFPDI and to assess the instrument's psychometric properties. METHODS: The MFPDI was translated into Greek by three bilingual content experts and two bilingual language experts, and then back-translated into English to assess for equivalence. The final Greek version was administered, along with a questionnaire consisting medical history and the Medical Outcomes Study Short Form 36 (SF-36), to 104 Greek-speaking, community-dwelling people (64 female, 40 male), aged between 64 and 90 years (mean 73.00, SD 5.26) with disabling foot pain. RESULTS: The Greek translation of the MFPDI was found to have high internal consistency (Cronbach's alpha= 0.89, and item-total correlation coefficients from 0.33 to 0.72). Principal components analysis revealed a four-factor structure representing the constructs of functional limitation, pain intensity, concern with appearance and activity restriction, which explained 60.8% of the variance, with 38.9% of the variance explained by the first construct (functional limitation). Six items demonstrated different factor loadings to the original English version. CONCLUSION: The Greek-language version of the MFPDI appears to be a valid tool in assessing foot pain in Greek-speaking older people. The total MFPDI scores are comparable between the Greek and English version, however due to differences in the factor loadings of some items, between-language comparisons of MFPDI should be undertaken with some caution.

Foot health service provision by the Australian Department of Veterans' Affairs: do major podiatric medical interventions reduce the number of maintenance treatments?

BACKGROUND: In Australia, the Department of Veterans' Affairs provides podiatric medical services, including nail surgery and the provision of footwear and orthoses, for war veterans and their dependents. We sought to evaluate whether the provision of these interventions reduces the number of ongoing maintenance treatments. METHODS: We used the database of the Department of Veterans' Affairs to document the number of major podiatric medical interventions (footwear, foot orthoses, nail surgery, and combinations of these interventions) for 1996-1997. The number of maintenance podiatric medical treatments provided in the 2 years before (1994-1996) and 2 years after (1997-1999) these interventions was then compared with a control group that did not receive any major interventions. RESULTS: Compared with the number of treatments in the 2 years before the interventions, in the subsequent 2 years there was a significant increase in the mean +/- SD number of maintenance treatments after receiving footwear only (10.4 +/- 5.8 versus 12.3 +/- 5.0), foot orthoses only (9.4 +/- 5.3 versus 12.2 +/- 4.6), nail surgery only (10.2 +/- 5.8 versus 13.2 +/- 4.4), and footwear plus foot orthoses (9.3 +/- 6.1 versus 13.3 +/- 5.5). In the control group, the mean number of treatments in 1994-1996 and 1997-1999 was 10.8 and 11.8, respectively. CONCLUSIONS: Provision of major podiatric medical interventions did not reduce the number of ongoing maintenance treatments received by veterans. However, owing to the inherent limitations of claims data, it is difficult to determine whether this finding is due to the limited efficacy of the interventions or to the policy structure of podiatric medical service provision in the Department of Veterans' Affairs.