High-risk Foot Research Articles

Response to: Comment on "Prevalence and Risk Factors for Diabetic Lower Limb Amputation: A Clinic-Based Case Control Study".

[Extract] The observations by Bakhtiyari and Mansournia on our study [1] were received with great interest. We believe our study was consistent with a case-control format [2]. In particular, our target population was selected from subjects diagnosed with diabetic foot ulcer (DFU) at the local high-risk foot clinic, effectively fulfilling the criteria of control (DFU without amputations) and case (DFU with amputation), as previously described [3].

Effectiveness of Diabetes Foot Screening in Primary Care in Preventing Lower Extremity Amputations

The risk of lower extremity amputations (LEAs) in diabetics is 20 times higher than in non-diabetics. Clinical practice guidelines recommend that all diabetics should receive an annual foot examination to identify high-risk foot conditions. Despite this recommendation, there is little evidence in the literature to show its effectiveness in preventing LEA. This study aims to evaluate the effectiveness of diabetes foot screening in primary care in preventing LEA and to identify LEA risk factors. This is a retrospective cohort study of diabetic patients who visited the National Healthcare Group Polyclinics for the first time from 1 January 2008 to 31 December 2012. The intervention of interest was foot screening performed at least once during 2 years of follow-up, and the outcome of interest was LEA (major and/or minor) performed during 2 years of follow-up. Patients who did foot screening (n=8150) were compared to a propensity score matched control group (n=8150) who did not do foot screening. Logistics regression was done to identify factors associated with LEA. Among those who underwent foot screening, there were 2 (0.02%) major amputations and 15 (0.18%) minor amputations compared with 42 (0.52%) and 52 (0.64%) among those who did not (P<0.001). Lack of diabetes foot screening, lower socioeconomic status, hip fracture, Malay ethnicity, chronic kidney disease, poorer glycaemic control, longer diabetes duration and male gender have been found to be associated with a higher risk of LEA.

Effects of topical negative pressure therapy on tissue oxygenation and wound healing in vascular foot wounds

ObjectiveTopical negative pressure (TNP) therapy is widely used in the treatment of acute wounds in vascular patients on the basis of proposed multifactorial benefits. However, numerous recent systematic reviews have concluded that there is inadequate evidence to support its benefits at a scientific level. This study evaluated the changes in wound volume, surface area, depth, collagen deposition, and tissue oxygenation when using TNP therapy compared with traditional dressings in patients with acute high-risk foot wounds. MethodsThis study was performed with hospitalized vascular patients. Forty-eight patients were selected with an acute lower extremity wound after surgical débridement or minor amputation that had an adequate blood supply without requiring further surgical revascularization and were deemed suitable for TNP therapy. The 22 patients who completed the study were randomly allocated to a treatment group receiving TNP or to a control group receiving regular topical dressings. Wound volume and wound oxygenation were analyzed using a modern stereophotographic wound measurement system and a hyperspectral transcutaneous oxygenation measurement system, respectively. Laboratory analysis was conducted on wound biopsy samples to determine hydroxyproline levels, a surrogate marker to collagen. ResultsDifferences in clinical or demographic characteristics or in the location of the foot wounds were not significant between the two groups. All patients, with the exception of two, had diabetes. The two patients who did not have diabetes had end-stage renal failure. There was no significance in the primary outcome of wound volume reduction between TNP and control patients on day 14 (44.2% and 20.9%, respectively; P = .15). Analyses of secondary outcomes showed a significant result of better healing rates in the TNP group by demonstrating a reduction in maximum wound depth at day 14 (36.0% TNP vs 17.6% control; P = .03). No significant findings were found for the other outcomes of changes in hydroxyproline levels (58.0% TNP vs 94.5% control; P = .32) or tissue perfusion by tissue oxyhemoglobin saturation (19.4% TNP vs 12.0% control; P = .07) at day 14. At 1 year of follow-up, there were no significant outcomes in the analysis of wound failure, major amputation, and overall survival rates between the two groups. ConclusionsIn this pilot study, applying TNP to acute high-risk foot wounds in patients with diabetes or end-stage renal failure improved the wound healing rate in reference to wound depth. This suggests that TNP may play a role in enhancing wound healing. This study sets the foundation for larger studies to evaluate the superiority of TNP over traditional dressings in high-risk foot wounds.

The prevalence of diabetic foot disease in the Waikato region.

The aim of this study was to establish the prevalence of diabetic foot disease by utilising the retinal eye screening register in the Waikato region of New Zealand. Understanding both the prevalence and the degree of foot disease across the general diabetes population will help to determine what podiatry services are required for people with diabetes. 2192 people aged 15years and over, who attended the Waikato Regional Diabetes Service mobile retinal photo screening service for the six-month period between May and November 2014, consented to a foot screen including testing for sensation and pedal pulses. A digital image was taken of the dorsal and plantar aspect of each foot for review by a registered Podiatrist. Thirteen percent of the study sample was identified as having a high-risk foot including active foot complications. 65% were categorised as low risk and a further 22% at moderate risk of diabetic foot disease. Factors identified as significant included age, type of diabetes, duration of diabetes, and smoking. These factors placed people at greater risk of diabetic foot disease. A significant number of people with diabetes are at risk of diabetic foot disease. This study has highlighted the need for targeted podiatry services to address diabetic foot disease.

A Novel Thermochromic Liquid Crystal Fabric Design for the Early Detection of High-Risk Foot Complications

We developed a prototype of a novel thermochromic liquid crystal (TLC)–coated fabric with an extended temperature range and enhanced sensitivity. By incorporating color and pattern recognition into the fabric, rapid determination of the underlying pedal temperature is facilitated. The purpose of this study was to evaluate the accuracy of the TLC fabric as a potential diagnostic aid for identifying complications in the high-risk foot. The hands of 100 individuals were used to compare the mean maximum temperatures indicated by the fabric versus standard thermal camera images. Findings were statistically analyzed using a paired <italic>t</italic> test, with significance defined as <italic>P</italic> < .05. Except for the tip of the thumb and regions in the palm, there were no statistically significant differences between mean maximum temperatures measured with the thermal camera and those detected with the TLC fabric. Minor differences were relatively consistent in all nine regions of the hand and were not considered to be clinically significant. Using direct visual analysis, we demonstrated that a novel TLC fabric could accurately map temperatures in the palmar surface of the hand. The findings support the continued development of a temperature-sensitive sock that can be used in the home to monitor for temperature changes that may indicate the onset of complications in the high-risk foot.

A medical thermal imaging device for the prevention of diabetic foot ulceration

In this paper a description is given of the development, characterisation and first results of a thermal imaging device aimed at significantly reducing the incidence of diabetic foot ulceration (DFU). These devices will be used in three clinical centres and in two preliminary clinical trials. The first will be on healthy volunteers to set a robust baseline for the overall research aims and the second on >100 patients at high risk of DFU. In the second phase of the project the objective is to demonstrate significant reduction in the incidence of DFU through a comparison of the results of standard care of high risk feet with standard care plus thermal imaging.

The effectiveness of felt padding for offloading diabetes-related foot ulcers, at baseline and after one week of wear

AimFelt padding is used to offload diabetes-related foot ulceration although limited quality data exists to support its use. This study aimed to quantify pressure offloading from neuropathic plantar foot ulcers in a clinical setting, when felt padding is first applied and after wear. MethodsThis study used a within-subjects, repeated measures design. Data was collected in a high-risk foot service. Peak plantar pressures, contact area and contact time were measured in 15 diabetes subjects with 16 non-complicated plantar neuropathic foot ulcers, with: no felt padding, newly applied felt padding and felt padding after one week of wear. ResultsStatistically significant decreases in peak pressure of 49% and 32% were measured with newly applied felt padding (188.0kPa; p<0.001) and worn felt padding (248kPa; p=0.003) respectively, compared to no padding (367.2kPa). Worn felt offloaded 32% less pressure than new felt however this did not reach statistical significance (p=.069). Corresponding increases in contact area of 18% and 14% occurred with newly applied felt padding (156.9cm2; p<.001) and worn felt padding (150.6cm2; p=0.003) compared to no padding (132.5cm2). Contact time was constant across testing conditions. ConclusionsNew felt padding offloaded on average half the pressure applied to sites of plantar neuropathic ulceration, which reduced to one third after wear. Increased contact area under the foot is a possible mechanism contributing to pressure reduction. Further studies are required to evaluate effectiveness of felt padding directly on ulcer healing.

The Evaluation of SPECT-CT in the Early Management of Acute Charcot Osteoarthropathy (CN)

Category: Diabetes Introduction/Purpose: Charcot osteooarthropathy (CN) is a debilitating condition afflicting the bone, soft tissue and joints of foot and ankle and is related to pain insensitivity. Its pathogenesis and natural progression is poorly understood. In patients with high clinical suspicion, treatment with immediate off-loading and immobilisation may halt and (help to) reverse or prevent deformity. We aim to establish the role of SPECT CT in the diagnosis of acute charcot osteoarthropathy of the red swollen foot prior to radiographic changes and assess its reliability in diagnostic accuracy and guiding treatment. Methods: A prospective, observational review of all patients presenting to the multidisciplinary diabetic foot clinic from 1st Jan 2009 to 1st Jan 2013 with clinically suspected acute active charcot arthropathy was performed. All patients with a high clinical suspicion of acute CN and normal radiographs, underwent SPECT-CT within 10 days of the assessment after emergency off-loading in a TCC. A positive SPECT CT scan for new onset acute CN was diagnosed if radioisotope uptake was seen in all 3 phases of scanning. Further CT fusion images provided localization of ongoing activity. All patients were followed up for 1-year or until treatment ceased and treated in concordance with clinical symptoms and SPECT CT imaging. Results: In total 137 patients were referred or self referred with a high suspicion of new onset acute CN. The majority being diabetic (98%), including 116 unilaterally symptomatic feet with normal radiographs; 86 were consequently positively confirmed on SPECT-CT CN; 15 new ‘diabetic’ fractures were diagnosed on the CT component. At 1 year – only 5 patients went on to develop radiological changes consistent with charcot arthropathy even with accepted off loading in TCC. Thirty negative scans were recorded where no triple phase trace response &amp; localisation was uni-focal or not associated with skeletal structures. Differential diagnosis included cellulitis, degenerative changes, old fractures, and planter fasciitis were made. At 1-year none of the patients were found to have developed CN in neither in the form of foot deformity nor radiological evidence of fragmentation or loss of normal bone anatomy. Conclusion: A combination of symptoms including swelling, pain and/or heat, positive three phase tracer uptake and localisation on SPECT CT can identify and aid the management of acute active CN in radiographically normal feet. Positive scans seem to identify an intermediate grade of charcot arthropathy where cortical fractures have occurred with significant subchondral bone turnover. A negative scan excludes high-risk feet for CN confidently and thus can direct treatment. We find SPECT CT a valuable addition to the armamentarium of the treating physician in instituting off loading to prevent the possible progression and onset of deformity and avoiding unnecessary treatment.

Fully customised insole design for people with diabetes and high risk feet

Fully customised insole design for people with diabetes and high risk feet

To Study the Association of HbA1c with Retinopathy, Neuropathy and High Risk Foot among Diabetic Patients Attending Rural Tertiary Care Hospital of Tamil Nadu, India

1 Assistant Professor, Department of Ophthalmology, SRM Medical College Hospital & Research Centre, Kattankulatur, Chennai, Tamilnadu, India. 2 Assistant Professor, Department of Community Medicine, SRM Medical College Hospital & Research Centre, Kattankulatur, Chennai, Tamilnadu, India. 3 Professor, Department of Ophthalmology, SRM Medical College Hospital & Research Centre, Kattankulatur, Chennai, Tamilnadu, India. 4 Professor, Department of General Medicine, SRM Medical College Hospital & Research Centre, Kattankulatur, Chennai, Tamilnadu, India.

Prevalence and Risk Factors for Diabetic Lower Limb Amputation: A Clinic-Based Case Control Study.

Objective. The aim of the study was to evaluate the prevalence of and risk factors for lower limb amputation in a specialist foot clinic-based setting. Methods. A retrospective quantitative study was conducted, using clinical and biochemical profiles of diabetic foot patients attending the High Risk Foot Clinic at The Townsville Hospital, Australia, between January 1, 2011, and December 31, 2013. Results. The total study sample included 129 subjects, comprising 81 males and 48 females with M : F ratio of 1.7 : 1. Twenty-three subjects were Indigenous Australians, representing 17.8% of the study population. The average age of the cohort was 63.4 years ± 14.1 years [CI 90.98–65.89]. Lower limb amputation was identified as a common and significant outcome (n = 44), occurring in 34.1%, more commonly amongst the Indigenous Australians (56.5% versus 29.2%; p = 0.94, OR 0.94). Risk factors most closely associated with amputation included diabetic retinopathy (p = 0.00, OR 4.4), coronary artery bypass graft (CABG) surgery (p = 0.01, OR 4.1), Charcot's arthropathy (p = 0.01, OR 2.9), and Indigenous ethnicity (p = 0.01, OR 3.4). Although average serum creatinine, corrected calcium, and glycosylated haemoglobin A1c (Hba1c) levels were higher amongst amputees they were statistically insignificant. Conclusions. Lower limb amputation is a common outcome and linked to ethnicity and neurovascular diabetic complications amongst subjects with diabetic foot ulcer. Further research is needed to identify why risk of lower limb amputation seems to differ according to ethnicity.

Diabetic foot disease: From the evaluation of the "foot at risk" to the novel diabetic ulcer treatment modalities.

The burden of diabetic foot disease (DFD) is expected to increase in the future. The incidence of DFD is still rising due to the high prevalence of DFD predisposing factors. DFD is multifactorial in nature; however most of the diabetic foot amputations are preceded by foot ulceration. Diabetic peripheral neuropathy (DPN) is a major risk factor for foot ulceration. DPN leads to loss of protective sensation resulting in continuous unconscious traumas. Patient education and detection of high risk foot are essential for the prevention of foot ulceration and amputation. Proper assessment of the diabetic foot ulceration and appropriate management ensure better prognosis. Management is based on revascularization procedures, wound debridement, treatment of infection and ulcer offloading. Management and type of dressing applied are tailored according to the type of wound and the foot condition. The scope of this review paper is to describe the diabetic foot syndrome starting from the evaluation of the foot at risk for ulceration, up to the new treatment modalities.

When and how to audit a diabetic foot service.

Quality improvement depends on data collection and audit of clinical services to inform clinical improvements. Various steps in the care of the diabetic foot can be used to audit a service but need defined audit standards. A diabetes foot service should have risk stratification system in place that should compare to the population-based figures of 76% having low-risk feet, 17% moderate risk and 7% being at high risk of ulceration. Resources can then be directed towards those with high-risk feet. Prevalence of foot ulceration needs to be audited. Community-based studies give an audit standard of around 2%, with 2 to 9% having had an ulcer at some stage in the past. Amputation rates should be easier to measure, and the best results are reported to be around 1.5-3 per 1000 people with diabetes. This is a useful benchmark figure, and the rate has been shown to decrease by approximately a third over the last 15 years in some centres. Ulceration rates and ulcer healing rates are the ultimate outcome audit measure as they are always undesirable, whilst occasionally for defined individuals, an amputation can be a good outcome. In addition to clinical outcomes, processes of care can be audited such as provision of clinical services, time from new ulcer to be seen by health care professional, inpatient foot care or use of antibiotics. Measurement of clinical services can be a challenge in the diabetic foot, but it is essential if clinical services and patient outcomes are to be improved.

Development of a Clinical Care Pathway for High Risk Feet in Patients with Diabetes

s / Can J Diabetes 39 (2015) 529e547 541 maintaining TG 62.2mmol/L; patient #2 -10.8 and 44.0 mmol/L; and patient #3 41.7 and >62.2 mmol/L respectively. Partial lipoprotein lipase deficiency was demonstrated molecularly in patient #3. Patients #1 and #2 received no PLEx, while patient #3 received a single course of PLEx within 24 hours of admission. By 72hours, plasma TGwas reduced by68%, 77% and 73% in patients #1, #2 and #3, respectively. All three patients were eventually discharged with essentially normal profiles. Conclusion: The clinical course in these three patients with severe HTG-induced pancreatitis suggests that PLEx is not necessary even in very severe cases, and that TG levels will correct rapidly with conservative measures. The role of PLEx in this situation should be addressed more formally in a clinical trial format. 044-2015. CLINICAL CARE A Patient Survey of Diabetes Patients in Hospital: Implications for Quality Improvement Strategies PETRA O’CONNELL*, JULIE A. MCKEEN, KARMON E. HELMLEy, GLENDA MOORE, EDWIN ROGERS

Outcomes and cost minimisation associated with outpatient parenteral antimicrobial therapy (OPAT) for foot infections in people with diabetes.

To determine clinical outcomes in patients with diabetic foot infections receiving outpatient parenteral antimicrobial therapy (OPAT), to evaluate cost savings from the use of OPAT and to analyse demographic, clinical and laboratory data that may predict OPAT failure. A retrospective cohort analysis was conducted between 1 January 2007 and 7 July 2012 at a tertiary referral hospital in metropolitan Sydney. Patients with diabetic foot infection were identified from the outpatient parenteral antimicrobial therapy database. Demographic, clinical, laboratory and operative report data were obtained from patient charts and electronic medical records. Potential cost savings were calculated on the estimated cost of expenditure versus the expected savings. Linear regression was used to explore outcomes associated with outpatient parenteral antimicrobial therapy failure. Fifty-nine patients were identified over the 5-year study period. The outpatient parenteral antimicrobial therapy success rate for diabetic foot infections was 88%. Following the resolution of the primary episode of infection, new infective episodes within the study period were high (n = 26, 44%). Regression analysis of variables for OPAT failure failed to indicate any factors reaching statistical significance. A total of 1569 days were saved by using outpatient parenteral antimicrobial therapy for an estimated total cost saving of $983,645 or $16,672 per patient. Outpatient intravenous therapy for diabetic foot infections is an effective mode of treatment that can contribute to significant healthcare savings. High re-infection rates associated with diabetes foot ulceration in this population underline the need for close monitoring and management of these patients in multidisciplinary high-risk foot setting.

Data-driven directions for effective footwear provision for the high-risk diabetic foot.

Custom-made footwear is used to offload the diabetic foot to prevent plantar foot ulcers. This prospective study evaluates the offloading effects of modifying custom-made footwear and aims to provide data-driven directions for the provision of effectively offloading footwear in clinical practice. Eighty-five people with diabetic neuropathy and a recently healed plantar foot ulcer, who participated in a clinical trial on footwear effectiveness, had their custom-made footwear evaluated with in-shoe plantar pressure measurements at three-monthly intervals. Footwear was modified when peak pressure was ≥ 200 kPa. The effect of single and combined footwear modifications on in-shoe peak pressure at these high-pressure target locations was assessed. All footwear modifications significantly reduced peak pressure at the target locations compared with pre-modification levels (range -6.7% to -24.0%, P < 0.001). The metatarsal heads were most frequently targeted. Repositioning an existing (trans-)metatarsal pad in the shoe insole (-15.9% peak pressure relief), applying local cushioning to the insole (-15.0%) and replacing the insole top cover with Plastazote (-14.2%) were the most effective single modifications. Combining a new Plastazote top cover with a trans-metatarsal bar (-24.0% peak pressure relief) or with local cushioning (-22.0%) were the most effective combined modifications. In people with diabetic neuropathy and a recently healed plantar foot ulcer, significant offloading can be achieved at high-risk foot regions by modifying custom-made footwear. These results provide data-driven directions for the design and evaluation of custom-made footwear for high-risk people with diabetes, and essentially mean that each shoe prescribed should incorporate those design features that effectively offload the foot.

Congestive heart failure presence predicts delayed healing of foot ulcers in diabetes: An audit from a multidisciplinary high-risk foot clinic

AimsThis retrospective study aimed to investigate both established and less well-explored factors as potential predictive variables for failed and delayed ulcer healing. MethodsPatients with type 1 or 2 diabetes with foot ulceration presenting consecutively to, and then subsequently managed at, a multidisciplinary, high-risk foot clinic were followed until ulcer healing, amputation or death. Data comprised prospective standardised documentation at each visit and retrospective collection from hospital records, and included patient demographics, comorbidities, laboratory variables, and ulcer infection, depth and area at each presentation. Multiple regression analysis was used to determine independent predictors of failure to heal and delayed healing. ResultsOf the 107 consecutive patients studied, 95 (89%) healed overall, 50 (47%) had healed in 12 weeks and the mean healing rate was a 10% decrease in ulcer area per week. Amongst all variables examined, comorbid congestive heart failure (CHF) was the only factor independently predictive of all measured outcomes of failure to heal overall, delayed healing at 12 weeks, and reduced healing rate. Ulcer infection at presentation, longer duration of antibiotic use, and liver enzyme abnormalities of raised ALT and AST:ALT<1 (each suggestive of non-alcoholic fatty liver disease), were also predictive of poor ulcer outcomes. ConclusionsComorbid congestive cardiac failure is predictive of delayed foot ulcer healing rate as well as a lower probability of healing overall. Liver enzyme abnormalities also predicted delayed ulcer healing outcomes. The mechanisms underlying these associations with foot ulcer outcomes in diabetes are unclear. Further studies are needed to determine the role of systematic routine documentation of heart failure and its severity, and then targeting of heart failure to potentially aid the management of foot ulcers in diabetes.

Primary care referral to multidisciplinary high risk foot services - too few, too late.

BackgroundTo determine if patients with no contact with a multi-disciplinary team High Risk Foot Service (MDT-HRFS) had an increased rate of hospital admission for diabetes foot infection compared to patients with contact. Secondary aims were to report on clinical outcomes.MethodsA retrospective study was conducted at a major tertiary referral hospital in metropolitan Sydney over 12 months. An ICD-10 search of the electronic medical record system and paper medical charts identified patients with diabetes mellitus (type 1 or type 2) and a primary admission for diabetes foot infection (DFI). Patients were categorised as having contact or no contact with an MDT-HRFS.ResultsOne hundred ninety-six hospital admissions (156 patients) were identified with DFI over a 12-month period. Patients with no contact with a MDT-HRFS represented three quarters of admissions (no contact = 116, 74.7 % vs. contact = 40, 25.6 %, p = 0.0001) and presented with more severe infection (no contact = 39 vs. contact = 12). The odds of lower extremity amputation increased five-fold when both no contact and severe infection occurred in combination (no contact with severe infection and amputation = 34, 82.9 % vs. contact with severe infection and amputation = 7, 17.1 %, OR 4.9, 95 % CI 1.1–21.4, p = 0.037). Using estimates of both the contact and no contact population of people with diabetes and high-risk feet and assuming the risk of amputation was the same, than the number of expected amputations in the no contact group should have been 55, however the observed number was 77, 22 more than expected (p = 0.0001).ConclusionsPatients with no contact with a MDT-HRFS represented the majority of admissions for DFIs to a tertiary referral hospital. This group on population estimates appears to be at high risk of amputation of the lower extremity and therefore early referral of this high-risk group might lower this risk.

Effectiveness and Complications Associated With Recombinant Human Bone Morphogenetic Protein-2 Augmentation of Foot and Ankle Fusions and Fracture Nonunions

Recombinant human bone morphogenetic protein-2 (rhBMP-2) has been used to augment bone healing and fusion in a variety of orthopaedic conditions. However, there is a paucity of data evaluating the potential benefits of its use in foot and ankle surgery. The purpose of this study was to investigate the effectiveness and associated complications with the use of rhBMP-2 in high-risk foot and ankle fusions and fracture nonunions. A total of 51 cases in 48 patients undergoing foot and ankle fusions or fracture nonunion revisions and considered at high risk for subsequent nonunion were identified through a retrospective review in which rhBMP-2 was used as an augment for bone healing. Rate of union, time to union, and associated complications were evaluated. Forty-seven of 51 high-risk cases treated with rhBMP-2 united for a per-case union rate of 92.2%. Seventy-eight of 82 individual sites treated with rhBMP-2 united for a per-site union rate of 95.1%. Of the successful unions, the mean time to union was 111 days (95% confidence interval, 101-121). There were no statistically significant differences in time to union with regard to supplementation with bone allograft or autograft or size of rhBMP-2 kit used. Complication rates were low. rhBMP-2 was a safe and apparently effective adjunct to bony union in high-risk foot and ankle surgeries. Further randomized controlled trials are warranted. Level IV, retrospective case series.

The Queensland high risk foot form (QHRFF) – is it a reliable and valid clinical research tool for foot disease?

BackgroundFoot disease complications, such as foot ulcers and infection, contribute to considerable morbidity and mortality. These complications are typically precipitated by “high-risk factors”, such as peripheral neuropathy and peripheral arterial disease. High-risk factors are more prevalent in specific “at risk” populations such as diabetes, kidney disease and cardiovascular disease. To the best of the authors’ knowledge a tool capturing multiple high-risk factors and foot disease complications in multiple at risk populations has yet to be tested. This study aimed to develop and test the validity and reliability of a Queensland High Risk Foot Form (QHRFF) tool.MethodsThe study was conducted in two phases. Phase one developed a QHRFF using an existing diabetes foot disease tool, literature searches, stakeholder groups and expert panel. Phase two tested the QHRFF for validity and reliability. Four clinicians, representing different levels of expertise, were recruited to test validity and reliability. Three cohorts of patients were recruited; one tested criterion measure reliability (n = 32), another tested criterion validity and inter-rater reliability (n = 43), and another tested intra-rater reliability (n = 19). Validity was determined using sensitivity, specificity and positive predictive values (PPV). Reliability was determined using Kappa, weighted Kappa and intra-class correlation (ICC) statistics.ResultsA QHRFF tool containing 46 items across seven domains was developed. Criterion measure reliability of at least moderate categories of agreement (Kappa > 0.4; ICC > 0.75) was seen in 91% (29 of 32) tested items. Criterion validity of at least moderate categories (PPV > 0.7) was seen in 83% (60 of 72) tested items. Inter- and intra-rater reliability of at least moderate categories (Kappa > 0.4; ICC > 0.75) was seen in 88% (84 of 96) and 87% (20 of 23) tested items respectively.ConclusionsThe QHRFF had acceptable validity and reliability across the majority of items; particularly items identifying relevant co-morbidities, high-risk factors and foot disease complications. Recommendations have been made to improve or remove identified weaker items for future QHRFF versions. Overall, the QHRFF possesses suitable practicality, validity and reliability to assess and capture relevant foot disease items across multiple at risk populations.