A mouldable fibreglass backslab device as a novel approach to offload chronic plantar foot ulcers: A retrospective observational audit.

BACKGROUND: Pressure offloading is a critical component of plantar foot ulcer management, including diabetes-related foot ulcers (DFU). Conventional offloading options such as total contact casting and removable knee-high walkers may be unsuitable or unsuccessful in patients with morbid obesity, intermittent lower limb oedema, high exudative wounds or poor mobility. A mouldable fibreglass backslab device (BSD) may be a practical alternative to be considered in these situations. METHODS: Data were retrospectively collected on 28 patients (29 foot ulcers) with non-healing ulcers who received a BSD to offload their foot ulcer as an extension to standard offloading care. Baseline data included: patient demographics, type of offloading prior to BSD application, date of ulcer onset, days ulcer present prior to BSD application and ulcer size at BSD initiation. Measures of success included ulcer size reduction 12 weeks post-BSD application, time to complete ulcer healing in BSD, time to 50% reduction in ulcer size post-BSD application and total number of days ulcer present. RESULTS: The median (IQR) ulcer area and ulcer duration at baseline for 19 patients (20 ulcers) who used the BSD was 1.65 (0.4-3.8) cm2 and 531 (101-635) days. At 12 weeks, the median (IQR) ulcer area was 0.3 (0-0.55) cm2 with a median (IQR) reduction of 97 (80-100) %. Nine (45%) ulcers achieved complete wound healing (100% reduction in wound size) at 12 weeks post-BSD application, and the remaining 11 (55%) ulcers achieved at least 50% reduction in wound size. The median (IQR) time to complete wound healing and 50% reduction in wound size was 71 (35-134) days and 24 (15-44) days, respectively. Nine patients ceased use of the BSD and reverted to conventional offloading before their wounds had healed. Of these, four patients achieved a 50% reduction in wound size at the 12-week mark with conventional offloading. CONCLUSION: Our preliminary data suggests that a mouldable fibreglass BSD may be a practical offloading option in the management of DFUs, especially when conventional offloading methods are unsuccessful, unsuitable or unacceptable to patients. Higher level evidence is required to demonstrate suitability or efficacy of the BSD compared to current evidence-based recommended offloading methods.

Exercise in adults admitted to hospital with diabetes-related foot ulcers: a pilot study of feasibility and safety.

BACKGROUND: Diabetes-related foot ulcers result in significant mortality, morbidity and economic costs. Pressure offloading is important for ulcer healing, but patients with diabetes-related foot ulcers are presented with a dilemma, because whilst they are often advised to minimise standing and walking, there are also clear guidelines which encourage regular, sustained exercise for patients with diabetes. To overcome these apparently conflicting recommendations, we explored the feasibility, acceptability and safety of a tailored exercise program for adults admitted to hospital with diabetes-related foot ulcers. METHODS: Patients with diabetes-related foot ulcers were recruited from an inpatient hospital setting. Baseline demographics and ulcer characteristics were collected, and participants undertook a supervised exercise training session comprising aerobic and resistance exercises followed by prescription of a home exercise programme. Exercises were tailored to ulcer location, which complied with podiatric recommendations for pressure offloading. Feasibility and safety were assessed via recruitment rate, retention rate, adherence to inpatient and outpatient follow up, adherence to home exercise completion, and recording of adverse events. RESULTS: Twenty participants were recruited to the study. The retention rate (95%), adherence to inpatient and outpatient follow up (75%) and adherence to home exercise (50.0%) were all acceptable. No adverse events occurred. CONCLUSIONS: Targeted exercise appears safe to be undertaken by patients with diabetes-related foot ulcers during and after an acute hospital admission. Recruitment in this cohort may prove challenging, but adherence, retention and satisfaction with participation in exercise were high. TRIAL REGISTRATION: The trial is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12622001370796).

Routine bacterial culture of proximal bone specimens during minor amputation in patients with diabetes-related foot infections has little clinical utility in predicting re-operation or ulcer healing.

BACKGROUND: Trans-phalangeal and trans-metatarsal amputation, collectively termed 'minor amputations' are important procedures for managing infections of diabetes-related foot ulcers (DFU). Following minor amputation, international guidelines recommend a prolonged course of antibiotics if residual infected bone on intra-operative bone samples are identified, but the quality of the evidence underpinning these guidelines is low. In this study, we examined the concordance of microbiological results from proximal bone cultures compared to results from superficial wound swabs in relation to patient outcomes; with the aim of determining the utility of routinely obtaining marginal bone specimens. METHODS: Data was retrospectively collected on 144 individuals who underwent minor amputations for infected DFU at a large Australian tertiary hospital. Concordance was identified for patients with both superficial wound swabs and intra-operative bone samples available. Patient outcomes were monitored up to 6 months post-amputation. The primary outcome was complete healing at 6 months; and secondary outcome measures included further surgery and death. Mann Whitney U testing was performed for bivariate analyses of continuous variables, Chi-Squared testing used for categorical variables and a logistic regression was performed with healing as the dependent variable. RESULTS: A moderate-high degree of concordance was observed between microbiological samples, with 38/111 (35%) of patients having discordant wound swab and bone sample microbiology. Discordant results were not associated with adverse outcomes (67.2% with concordant results achieved complete healing compared with 68.6% patients with discordant results; P = 0.89). Revascularisation during admission (0.37 [0.13-0.96], P = 0.04) and amputation of the 5th ray (0.45 [0.21-0.94], P = 0.03) were independent risk factors for non-healing. CONCLUSION: There was a moderate-high degree of concordance between superficial wound swab results and intra-operative bone sample microbiology in this patient cohort. Discordance was not associated with adverse outcomes. These results suggest there is little clinical utility in routinely collecting proximal bone as an adjunct to routine wound swabs for culture during minor amputation for an infected DFU.

Wound healing with "spray-on" autologous skin grafting (ReCell) compared with standard care in patients with large diabetes-related foot wounds: an open-label randomised controlled trial.

There is an urgent need for interventions that improve healing time, prevent amputations and recurrent ulceration in patients with diabetes-related foot wounds. In this randomised, open-label trial, participants were randomised to receive an application of non-cultured autologous skin cells ("spray-on" skin; ReCell) or standard care interventions for large (>6 cm2 ), adequately vascularised wounds. The primary outcome was complete healing at 6 months, determined by assessors blinded to the intervention. Forty-nine eligible foot wounds in 45 participants were randomised. An evaluable primary outcome was available for all wounds. The median (interquartile range) wound area at baseline was 11.4 (8.8-17.6) cm2 . A total of 32 (65.3%) index wounds were completely healed at 6 months, including 16 of 24 (66.7%) in the spray-on skin group and 16 of 25 (64.0%) in the standard care group (unadjusted OR [95% CI]: 1.13 (0.35-3.65), P = .845). Lower body mass index (P = .002) and non-plantar wounds (P = .009) were the only patient- or wound-related factors associated with complete healing at 6 months. Spray-on skin resulted in high rates of complete healing at 6 months in patients with large diabetes-related foot wounds, but was not significantly better than standard care (Australian New Zealand Clinical Trials Registry: ACTRN12618000511235).

Reduction in femoral neck and total hip bone mineral density following hospitalisation for diabetes-related foot ulceration.

Management of diabetes-related foot ulceration (DFU) includes pressure offloading resulting in a period of reduced activity. The metabolic effects of this are unknown. This study aims to investigate changes in bone mineral density (BMD) and body composition 12 weeks after hospitalisation for DFU. A longitudinal, prospective, observational study of 22 people hospitalised for DFU was conducted. Total body, lumbar spine, hip and forearm BMD, and total lean and fat mass were measured by dual-energy X-ray absorptiometry (DXA) during and 12 weeks after hospitalisation for DFU. Significant losses in total hip BMD of the ipsilateral limb (- 1.7%, p < 0.001), total hip BMD of the contralateral limb (- 1.4%, p = 0.005), femoral neck BMD of the ipsilateral limb (- 2.8%, p < 0.001) and femoral neck BMD of the contralateral limb (- 2.2%, p = 0.008) were observed after 12 weeks. Lumbar spine and forearm BMD were unchanged. HbA1c improved from 75 mmol/mol (9.2%) to 64 mmol/mol (8.0%) (p = 0.002). No significant changes to lean and fat mass were demonstrated. Total hip and femoral neck BMD decreased bilaterally 12 weeks after hospitalisation for DFU. Future research is required to confirm the persistence and clinical implications of these losses.

Subcutaneous ertapenem delivered by an Australian outpatient parenteral antimicrobial therapy service: a retrospective comparative efficacy study.

Subcutaneous (SC) administration of ertapenem in outpatient parenteral antimicrobial therapy (OPAT) services may be a practical alternative to intravenous delivery for complicated infections. The clinical features and outcomes according to route of administration were compared from a large Australian OPAT service. Chronic renal impairment was more common in the SC group, reflecting an opportunity for route of administration as a vein preservation strategy. Adverse events were uncommon and successful outcomes were not different between the groups.

Management of diabetes-related foot disease in the outpatient setting during the COVID-19 pandemic.

The use of telephone and/or video consultation in routine management of acute diabetes-related foot disease (DFD) before the coronavirus disease 2019 (COVID-19) pandemic at a tertiary hospital is unprecedented. In March 2020, the Diabetes Feet Australia (DFA) released a national guideline to inform DFD management during the COVID-19 pandemic. The present study aimed to describe the adherence to the DFA guideline of managing acute DFD using telephone and/or video consultation at a Western Australian tertiary hospital during this period. We found >80% adherence rate to the DFA guideline and the management of active DFD using telephone and/or video consultations was feasible and acceptable in carefully selected patients.

Cognitive Impairment in People with Diabetes-Related Foot Ulceration.

AIMS: To determine whether there is an excess of cognitive impairment in patients with type 2 diabetes and foot ulceration. METHODS: 55 patients with type 2 diabetes and foot ulcers attending Multidisciplinary Diabetes Foot Ulcer clinics (MDFU cohort) were compared with 56 patients with type 2 diabetes attending Complex Diabetes clinics (CDC cohort) using commonly used screening tests for cognitive impairment (Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MOCA)), as well as foot self-care, mood and health literacy. MMSE was also compared between the MDFU cohort and a historical community-based cohort of patients with type 2 diabetes (FDS2 cohort). RESULTS: Median MMSE scores were the same in all three groups (28/30). Median MOCA scores did not differ between the MDFU and CDC cohorts (25/30). There were no significant differences in the percentages of patients with MMSE ≤ 24 or MOCA ≤ 25 between MDFU and CDC cohorts (3.6% versus 10.7%, p = 0.27 and 56.4% versus 51.8%, p = 0.71, respectively), findings that did not change after adjustment for age, sex, education, diabetes duration, and random blood glucose. CONCLUSIONS: Using conventionally applied instruments, patients with type 2 diabetes and foot ulceration have similar cognition compared with patients without, from either hospital-based clinic or community settings.

Availability and service provision of multidisciplinary diabetes foot units in Australia: a cross-sectional survey.

BACKGROUND: With growing global prevalence of diabetes mellitus, diabetes-related foot disease (DFD) is contributing significantly to disease burden. As more healthcare resources are being dedicated to the management of DFD, service design and delivery is being scrutinised. Through a national survey, this study aimed to investigate the current characteristics of services which treat patients with DFD in Australia. METHODS: An online survey was distributed to all 195 Australian members of the Australian and New Zealand Society for Vascular Surgery investigating aspects of DFD management in each member's institution. RESULTS: From the survey, 52 responses were received (26.7%). A multidisciplinary diabetes foot unit (MDFU) was available in more than half of respondent's institutions, most of which were tertiary hospitals. The common components of MDFU were identified as podiatrists, endocrinologists, vascular surgeons and infectious disease physicians. Many respondents identified vascular surgery as being the primary admitting specialty for DFD patients that require hospitalisation (33/52, 63.5%). This finding was consistent even in centres with MDFU clinics. Less than one third of MDFUs had independent admission rights. CONCLUSIONS: The present study suggests that many tertiary centres in Australia provide their diabetic foot service in a multidisciplinary environment however their composition and function remain heterogeneous. These findings provide an opportunity to evaluate current practice and, to initiate strategies aimed to improve outcomes of patients with DFD.

Spray on skin for diabetic foot ulcers: an open label randomised controlled trial.

BACKGROUND: One Australian loses a limb every 3 h as a result of infected diabetic foot ulcers (DFU). This common condition accounts for substantial morbidity and mortality for affected individuals and heavy economic costs for the health sector and the community. There is an urgent need to test interventions that improve wound healing time, prevent amputations and recurrent ulceration in patients presenting with DFU whilst improving quality of life and reducing health care costs. METHODS: One hundred and fifty eligible participants will be randomised to receive an autologous skin cell suspension, also termed 'spray-on' skin (ReCell®) or standard care interventions for their DFU. The primary outcome is complete wound healing at 6 months, but participants will be followed up for a total of 12 months to enable secondary outcomes including total overall costs, ulcer free days at 12 months and quality of life to be assessed. DISCUSSION: Outpatient costs for dressings, home nursing visits and outpatient appointments are key cost drivers for DFU. If spray-on skin is effective, large cost savings to WA Health will be realised immediately through a shortened time to healing, and through a higher proportion of patients achieving complete healing. Shortened healing times may enable participants to return to work earlier. Any economic benefits are likely to be amplified across Australia and other similar demographic settings where aging populations with increased diabetes rates are considered major future challenges. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618000511235. Registered on 9 April 2018.