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Background: It is critical that interventions used to enhance the healing of chronic foot ulcers in diabetes are backed by high‐quality evidence and cost‐effectiveness. In previous years, the systematic review accompanying guidelines published by the International Working Group of the Diabetic Foot performed 4‐yearly updates of previous searches, including trials of prospective, cross‐sectional and case‐control design. Aims: Due to a need to re‐evaluate older studies against newer standards of reporting and assessment of risk of bias, we performed a whole new search from conception, but limiting studies to randomised control trials only. Materials and Methods: For this systematic review, we searched PubMed, Scopus and Web of Science databases for published studies on randomised control trials of interventions to enhance healing of diabetes‐related foot ulcers. We only included trials comparing interventions to standard of care. Two independent reviewers selected articles for inclusion and assessed relevant outcomes as well as methodological quality. Results: The literature search identified 22,250 articles, of which 262 were selected for full text review across 10 categories of interventions. Overall, the certainty of evidence for a majority of wound healing interventions was low or very low, with moderate evidence existing for two interventions (sucrose‐octasulfate and leucocyte, platelet and fibrin patch) and low quality evidence for a further four (hyperbaric oxygen, topical oxygen, placental derived products and negative pressure wound therapy). The majority of interventions had insufficient evidence. Conclusion: Overall, the evidence to support any other intervention to enhance wound healing is lacking and further high‐quality randomised control trials are encouraged. [ABSTRACT FROM AUTHOR]

Aims: Principles of wound management, including debridement, wound bed preparation, and newer technologies involving alternation of wound physiology to facilitate healing, are of utmost importance when attempting to heal a chronic diabetes‐related foot ulcer. However, the rising incidence and costs of diabetes‐related foot ulcer management necessitate that interventions to enhance wound healing of chronic diabetes‐related foot ulcers are supported by high‐quality evidence of efficacy and cost effectiveness when used in conjunction with established aspects of gold‐standard multidisciplinary care. This is the 2023 International Working Group on the Diabetic Foot (IWGDF) evidence‐based guideline on wound healing interventions to promote healing of foot ulcers in persons with diabetes. It serves as an update of the 2019 IWGDF guideline. Materials and Methods: We followed the GRADE approach by devising clinical questions and important outcomes in the Patient‐Intervention‐Control‐Outcome (PICO) format, undertaking a systematic review, developing summary of judgements tables, and writing recommendations and rationale for each question. Each recommendation is based on the evidence found in the systematic review and, using the GRADE summary of judgement items, including desirable and undesirable effects, certainty of evidence, patient values, resources required, cost effectiveness, equity, feasibility, and acceptability, we formulated recommendations that were agreed by the authors and reviewed by independent experts and stakeholders. Results: From the results of the systematic review and evidence‐to‐decision making process, we were able to make 29 separate recommendations. We made a number of conditional supportive recommendations for the use of interventions to improve healing of foot ulcers in people with diabetes. These include the use of sucrose octasulfate dressings, the use of negative pressure wound therapies for post‐operative wounds, the use of placental‐derived products, the use of the autologous leucocyte/platelet/fibrin patch, the use of topical oxygen therapy, and the use of hyperbaric oxygen. Although in all cases it was stressed that these should be used where best standard of care was not able to heal the wound alone and where resources were available for the interventions. Conclusions: These wound healing recommendations should support improved outcomes for people with diabetes and ulcers of the foot, and we hope that widescale implementation will follow. However, although the certainty of much of the evidence on which to base the recommendations is improving, it remains poor overall. We encourage not more, but better quality trials including those with a health economic analysis, into this area. [ABSTRACT FROM AUTHOR]

In this paper we describe a method for exploring young children's views of illness causality in social context. Studies of children's conceptualisation of illness have predominantly focused on the nature of children's knowledge rather than locating that knowledge within socio-cultural contexts. Adopting a socio-constructivist perspective we sought to identify the ways in which young children's illness causality concepts are embedded in the socio-cultural context of the family. Interviews were undertaken with four-year-old children, their parents/guardians, sibling/s aged five to nine years and two other family members. To aid the elicitation of young children's narrative accounts of illness causality, children were invited to construct a storybook about "getting sick" utilising art materials and photographs of children experiencing illness. In this paper we describe this method, discuss its utility in eliciting illness narratives from pre-school children and provide suggestions for the use of this method in future research.

Autonomic neuropathy in the diabetic foot is associated with decreased sweating, loss of skin temperature regulation and interruption of sympathetic nerve function. The associated sudomotor dysfunction can cause anhidrosis in the feet, leading to callus, fissures or ulceration. There is no internationally recommended or recognised standardised tool to diagnose sudomotor dysfunction in the lower limb, and it is also unclear if currently available tools validly measure anhidrosis. This study investigates associations between clinician-observed anhidrosis, Neuropad®-detected anhidrosis and Michigan Neuropathy Screening Instrument (MNSI) findings in a sample of 50 participants with diabetes who attended a community podiatry service in the West of Ireland. Diabetic peripheral neuropathy was assessed using the Michigan Neuropathy Screening Instrument and Neuropad. The clinician-observed anhidrosis did not correlate with MNSI or Neuropad findings. [ABSTRACT FROM AUTHOR]

Abstract Background Randomised controlled trials are widely accepted as the gold standard method to evaluate medical interventions, but they are still open to bias. One such bias is the effect of patient’s preference on outcome measures. The aims of this study were to examine whether patients’ treatment preference affected clearance of plantar warts and explore whether there were any associations between patients’ treatment preference and baseline variables in the EverT trial. Methods Two hundred and forty patients were recruited from University podiatry schools, NHS podiatry clinics and primary care. Patients were aged 12 years and over and had at least one plantar wart which was suitable for treatment with salicylic acid and cryotherapy. Patients were asked their treatment preference prior to randomisation. The Kruskal-Wallis test was performed to test the association between preference group and continuous baseline variables. The Fisher’s exact test was performed to test the association between preference group and categorical baseline variables. A logistic regression analysis was undertaken with verruca clearance (yes or no) as the dependent variable and treatment, age, type of verruca, previous treatment, treatment preference as independent variables. Two analyses were undertaken, one using the health professional reported outcome and one using the patient’s self reported outcomes. Data on whether the patient found it necessary to stop the treatment to which they had been allocated and whether they started another treatment were summarised by treatment group. Results Pre-randomisation preferences were: 10% for salicylic acid; 42% for cryotherapy and 48% no treatment preference. There was no evidence of an association between treatment preference group and either patient (p=0.95) or healthcare professional (p=0.46) reported verruca clearance rates. There was no evidence of an association between preference group and any of the baseline variables except gender, with more females expressing a preference for salicylic acid (p=0.004). There was no evidence that the number of times salicylic acid was applied was different between the preference groups at one week (p=0.89) or at three weeks (p=0.24). Similarly, for the number of clinic visits for cryotherapy (p=0.71) Conclusions This secondary analysis showed no evidence to suggest that patients’ baseline preferences affected verruca clearance rates or adherence with the treatment. Trial registration Current Controlled Trials ISRCTN18994246 and National Research Register N0484189151

Abstract Background Plantar warts (verrucae) are extremely common. Although many will spontaneously disappear without treatment, treatment may be sought for a variety of reasons such as discomfort. There are a number of different treatments for cutaneous warts, with salicylic acid and cryotherapy using liquid nitrogen being two of the most common forms of treatment. To date, no full economic evaluation of either salicylic acid or cryotherapy has been conducted based on the use of primary data in a pragmatic setting. This paper describes the cost-effectiveness analysis which was conducted alongside a pragmatic multicentre, randomised trial evaluating the clinical effectiveness of cryotherapy versus 50% salicylic acid of the treatment of plantar warts. Methods A cost-effectiveness analysis was undertaken alongside a pragmatic multicentre, randomised controlled trial assessing the clinical effectiveness of 50% salicylic acid and cryotherapy using liquid nitrogen at 12 weeks after randomisation of patients. Cost-effectiveness outcomes were expressed as the additional cost required to completely cure the plantar warts of one additional patient. A NHS perspective was taken for the analysis. Results Cryotherapy costs on average £101.17 (bias corrected and accelerated (BCA) 95% CI: 85.09-117.26) more per participant over the 12 week time-frame, while there is no additional benefit, in terms of proportion of patients healed compared with salicylic acid. Conclusions Cryotherapy is more costly and no more effective than salicylic acid. Trial registration Current Controlled Trials ISRCTN18994246 [controlled-trials.com] and National Research Register N0484189151.

To date, research into interventions to promote wound healing has been led by scientists, clinicians, industry and academics, each with their own particular area of interest. However, the real experts in this area are the people who live with wounds and their families and heretofore their voice has not influenced or shaped the research agenda. This event aimed to seek patient and carer involvement as experts due to their lived experience in wounds through a partnership approach to identify research priorities and address a lack of patient and carer involvement in wound care research. A roundtable discussion format guided by the Scottish Health Council Participation Toolkit Supporting Patient Focus and Public Involvement in NHS Scotland was utilised. The Guidance for Reporting Involvement of Patients and the Public 2 – Short Form (GRIPP2-SF) guided the reporting process. Key areas for future research were identified and included; Patients and carers prioritised the establishment of support groups and the development of educational resources. Research priorities that emerged included understanding the impact of wounds, pain management, addressing educational needs and quantifying the financial burden on patients and carers of living with a wound. A key conclusion from this roundtable was that patients and their carers expressed a strong interest in further wound care related public and patient involvement events and identified areas for future research. [ABSTRACT FROM AUTHOR]

We set out to evaluate quality of reporting of data related to external validity from randomized controlled trials (RCTs) assessing treatment interventions for active venous leg ulcers. Using a systematic review study design, we identified 144 full‐text RCTs of treatment interventions, where the wound was assessed and published in English from 1998 to 2018. We found that the median study sample size was 75.5. Weighted mean wound size was 13.22 cm2 and weighted mean wound duration was 22.20 months. Forty‐six (32%) reported numbers screened for eligibility and 27 (19%) reported the number who declined to participate; 19 (13%) reported on patient ethnicity; 60 (42%) reported comorbidities; and 5 (4%) reported current medication use. When reported, 60/102 (59%) excluded patients with an ankle‐brachial pressure index <0.8; 68/135 (50%) were conducted in Europe, 6/135 (4%) in Asia, and 74/104 (71%) were conducted in outpatient facilities; 3 (2%) reported socioeconomic factors and 88 (61%) reported on adverse events. We concluded that there is inadequate reporting of data related to external validity in reports of RCTs assessing venous leg ulcers treatment interventions. Significant variability exists in the ankle‐brachial pressure index cutoff point for inclusion or exclusion, making generalizability difficult to assess. [ABSTRACT FROM AUTHOR]

Objective: To estimate the cost of wound care to the Irish health-care system. Methods: A bottom-up, prevalence-based analysis was undertaken using a decision analytic model to estimate costs. Health-care resource activity was identified from a recently published study from the UK and was valued using unit cost data for Ireland. Results: The base case analysis estimated the total annual healthcare cost of wound care to be €629,064,198 (95% Confidence interval (CI): €452,673,358 to €844,087,124), accounting for 5% (95% CI: 3% to 6%) of total public health expenditure in Ireland in 2013. The average cost per patient was €3,941 (95% CI: €2,836 to €5,287). However, this study is subject to many limitations and plausible changes in the model's inputs showed that the total annual health-care cost of wound care could range from €281,438,970 to €844,316,912. Conclusion: Caring for wounds places a substantial burden on the Irish health-care system. In light of growing pressures to finance an already resource-constrained health-care system, these results provide useful information for those charged with future wound care service design and provision in Ireland and elsewhere. [ABSTRACT FROM AUTHOR]

Background Living with diabetic foot ulceration (DFU) can have a significant impact on a person's physical and psychological health. Clinicians involved in the treatment of DFU patients should possess sufficient knowledge and understanding of the total impact of living with a DFU, including an awareness of an individual's wellbeing. Aim To provide an overview of the current literature with regard to wellbeing in patients affected by DFU by considering current outcome measures used to assess domains of wellbeing in this population. Findings The psychological, physical, spiritual, and cultural domains of wellbeing all impact an individual's overall wellbeing. There is no one standardised tool available that assesses all four domains of wellbeing specific to those with DFU. It is important for clinicians to be aware that all members of the multidisciplinary team have a responsibility to consider the importance of wellbeing assessment and to be mindful of suggested approaches. Conclusions There is a need for a reliable and valid measurement tool to assess overall wellbeing in people living with DFU. Implications for clinical practice This review highlights the importance of the inclusion of wellbeing assessment in optimising wound care for individuals with DFU. [ABSTRACT FROM AUTHOR]

Effective management of wound exudate in diabetic foot ulcers (DFUs) is a key component of any wound management plan and crucial to facilitate the healing of DFUs. It is important, therefore, that clinicians involved in the management of DFUs understand the role and function of wound exudate and, importantly, can recognise when exudate can become detrimental to the healing process. This article provides an overview of wound exudate, its role and constituents, and outlines current best practice in managing wound exudate to best facilitate wound healing and wound closure in DFUs. [ABSTRACT FROM AUTHOR]

Aim: To investigate pain in patients with Diabetic foot ulcer (DFU) and its impact on their HRQOL. Method: This was a cross-sectional descriptive study, obtained sample of 30 participants from MPPC, Galway, Ireland. Pain was assessed using short-form McGill questionnaire (SF-MPQ), HRQOL was assessed Cardiff Wound Impact schedule (CWIS) questionnaire. Results / Discussion: DFU pain was reported by 70% (n=21) of participants. The majority of participants (n=16) experience "mild" to "distressing" pain, the remaining 23 % (n=5) experiencing "severe" pain. The most common sensory pain descriptors reported were "tender", "aching", and "throbbing", indicating nociceptive pain. Significant correlations between VAS and total SF-MPQ score were observed across all CWIS domains and the total CWIS score. Social life (rs=-0.710, p=<0.001) and Physical symptoms and daily living and (rs=-0.665, p=<0.001) demonstrating the strongest negative correlations. Patients with no DFU pain experience superior quality of life (Mr=22, P=0.09) compared to DFU pain where both neuropathic and nociceptive pain coexist (Mr=9, P=0.09). With statistically significant differences in the domains Social Life (Mr=22, Mr=90). The presence of DFU negatively impacts patients' health-related quality of life (HRQOL) due to many factors, one of which is pain. There is a general misconception that patients with DFU do not experience wound-related pain due to the high incidence of diabetic neuropathy among them, attributing the presence of any DFU pain to ischaemia, infection and/or Charcot arthropathy. A growing evidence base challenges previous presumptions surrounding DFU pain, reporting this as a significant factor effecting HRQOL among people with DFU. Conclusion: This study identifies classification of DFU pain as a viable contributor to the identification and implementation of effective DFU management strategies. [ABSTRACT FROM AUTHOR]

Aim: To investigate wellbeing in those who are at high risk of or living with an active diabetic foot ulcer (DFU) attending a community Podiatry clinic in the West of Ireland. Method: A total of 25 participants at risk or/ active DFUs were recruited. In addition to demographic information, Phase 1 (n = 25) assessed: Spirituality Self Rating Scale (SSRS), Hearth Hope Index (HHI), Hospital Anxiety and Depression Score (HADS), Rosenberg Self-Esteem Scale (RSES) and Powerlessness Assessment Tool (PAT). Phase 2 (n = 10) utilised a qualitative approach and explored the lived experience of those at high risk (n=4) and those living with active (n = 6) DFU through one-to-one follow-up interviews. Results / Discussion: Sixty-four percent (n=16) had current ulceration. Mean age was 69.64 (±11.47) and disease duration 21.28 years (±10.76). Male: Female gender distribution was 76% (n = 19)/ 24% (n = 6). The following mean scores were identified: SSRS 21.24 (±6.78), HHI 37.28 (±6.17), RSES 20.84 (±5.02), PAT 28.88 (±7.91), and HADS = 9 (±5.33). Individuals with current DFU presented with lower levels of self-esteem, stronger feelings of powerlessness, higher levels of depression and lower levels of anxiety when compared to those who were at risk, but not currently ulcerated. Conclusion: Participants living with current DFUs reported stronger feelings of powerlessness, lower self-esteem and higher depression scores than those who are high risk of DFUs. Those with current DFUs reported significantly lower anxiety levels compared to the high-risk group. Healthcare professionals should consider the impact that DFU may have on wellbeing and future work should investigate if addressing these factors can improve patient outcomes. [ABSTRACT FROM AUTHOR]

Diabetic foot disease and chronic kidney disease (CKD) are strong predictive risk factors for the development of diabetic foot ulceration (DFU). Individuals with CKD, particularly those with end-stage renal disease (ESRD), are known to be at high risk of developing foot complications, including DFU and lower-extremity amputation. The onset and progression of CKD can be monitored through the analysis of estimated glomerular filtration rate (eGFR). The emerging literature investigating declining kidney function in association with DFU primarily focuses on stage 4 and stage 5 ESRD (e-GFR <29). Previous studies have identified a temporal relationship between dialysis and foot ulceration. Further research is warranted to comprehensively analyse the relationship between DFD and diabetic nephropathy to truly understand the interrelationship between these common, microvascular complications of diabetes. [ABSTRACT FROM AUTHOR]

Background: Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention. Design: Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness. Results: In the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained. Conclusion: There was a small reduction in falls. The intervention may be cost-effective. Trial Registration: ISRCTN ISRCTN68240461 [ABSTRACT FROM AUTHOR]

Background: Trials using inadequate levels of blinding may report larger effect sizes than blinded studies. It has been suggested that blinded outcome assessment in open trials may in some cases be undertaken by assessments of photographs. The aim of this paper is to explore the effect of using different methods to assess the primary outcome in the EVerT (Effective Verruca Treatments) trial. It also aims to give an overview of the experiences of using digital photographs within the trial. Methods: We undertook a secondary analysis to explore the effect of using three different methods to assess the primary outcome in the EVerT trial: assessment of digital photographs by blinded healthcare professionals; blinded healthcare professional assessment at the recruiting site and patient self-report. The verruca clearance rates were calculated using the three different methods of assessment. A Cohen's kappa measure of inter-rater agreement was used to assess the agreement between the methods. We also investigated the experiences of healthcare professionals using digital photographs within the trial. Results: Digital photographs for 189 out of 240 (79 %) patients in the trial were received for outcome assessment. Of the 189 photographs, 30 (16 %) were uninterpretable. The overall verruca clearance rates were 21 % (43/202,) using the unblinded patient self-reported outcome, 6 % (9/159,) using blinded assessment of digital photographs and 14 % (30/210,) using blinded outcome assessment at the site. Conclusions: Despite differences in the clearance rates found using different methods of outcome assessment, this did not change the original conclusion of the trial, that there is no evidence of a difference in effectiveness between cryotherapy and salicylic acid. Future trials using digital photographs should consider individual training needs at sites and have a backup method of assessment agreed a priori. Trial registration: ISRCTN Registry ISRCTN18994246 [ABSTRACT FROM AUTHOR]

Introduction: Falls and fall-related injuries are a serious cause of morbidity and cost to society. Foot problems and inappropriate footwear may increase the risk of falls; therefore podiatric interventions may play a role in reducing falls. Two Cochrane systematic reviews identified only one study of a podiatry intervention aimed to reduce falls, which was undertaken in Australia. The REFORM trial aims to evaluate the clinical and cost-effectiveness of a multifaceted podiatry intervention in reducing falls in people aged 65 years and over in a UK and Irish setting. Methods and analysis: This multicentre, cohort randomised controlled trial will recruit 2600 participants from routine podiatry clinics in the UK and Ireland to the REFORM cohort. In order to detect a 10% point reduction in falls from 50% to 40%, with 80% power 890 participants will be randomised to receive routine podiatry care and a falls prevention leaflet or routine podiatry care, a falls prevention leaflet and a multifaceted podiatry intervention. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by patient self-report falls diary. Secondary self-report outcome measures include: the proportion of single and multiple fallers and time to first fall over a 12-month period; Short Falls Efficacy Scale-International; fear of falling in the past 4 weeks; Frenchay Activities Index; fracture rate; Geriatric Depression Scale; EuroQoL-five dimensional scale 3-L; health service utilisation at 6 and 12 months. A qualitative study will examine the acceptability of the package of care to participants and podiatrists. Ethics and dissemination: The trial has received a favourable opinion from the East of England- Cambridge East Research Ethics Committee and Galway Research Ethics Committee. The trial results will be published in peer-reviewed journals and at conference presentations. [ABSTRACT FROM AUTHOR]