A shift in priority in diabetic foot care and research: 75% of foot ulcers are preventable.

Diabetic foot ulceration poses a heavy burden on the patient and the healthcare system, but prevention thereof receives little attention. For every euro spent on ulcer prevention, ten are spent on ulcer healing, and for every randomized controlled trial conducted on prevention, ten are conducted on healing. In this article, we argue that a shift in priorities is needed. For the prevention of a first foot ulcer, we need more insight into the effect of interventions and practices already applied globally in many settings. This requires systematic recording of interventions and outcomes, and well-designed randomized controlled trials that include analysis of cost-effectiveness. After healing of a foot ulcer, the risk of recurrence is high. For the prevention of a recurrent foot ulcer, home monitoring of foot temperature, pressure-relieving therapeutic footwear, and certain surgical interventions prove to be effective. The median effect size found in a total of 23 studies on these interventions is large, over 60%, and further increases when patients are adherent to treatment. These interventions should be investigated for efficacy as a state-of-the-art integrated foot care approach, where attempts are made to assure treatment adherence. Effect sizes of 75-80% may be expected. If such state-of-the-art integrated foot care is implemented, the majority of problems with foot ulcer recurrence in diabetes can be resolved. It is therefore time to act and to set a new target in diabetic foot care. This target is to reduce foot ulcer incidence with at least 75%.

Use of locally made off-loading techniques for diabetic plantar foot ulcer in Karachi, Pakistan.

The aim of this study was to evaluate the effectiveness of applying locally made pressure off-loading techniques on plantar foot ulcer in individuals with diabetes. This prospective study of 70 diabetic patients was conducted at the foot clinic of Baqai Institute of Diabetology & Endocrinology. Plantar foot ulcer, stages 1A and 2A according to the University of Texas classification, was treated by using three off-loading techniques: modified foot wear (sandal), modified plaster of Paris cast with plywood platform and Scotchcast boot. The outcome was assessed at either complete wound healing (defined as complete epithelialisation) or at 12 weeks, whichever came first. Of the 70 patients, 24 were in modified foot wear group, 23 in modified plaster of Paris cast and 23 in Scotchcast boot group. There was almost equal proportion of patients healed within 12 weeks period treated with these three off-loading techniques, i.e. 22 (95·7%) for modified foot wear group, 19 (95%) for modified plaster cast and 18 (94·7%) for Scotchcast boot group. No significant difference was observed in median healing time and cumulative wound survival at 12 weeks in the three off-loading techniques. Modified foot wear group was the most cost effective ($7) amongst the three off-loading techniques. It is concluded that in this cohort, no significant difference in healing time was observed in the three off-loading techniques, although modified foot wear (sandal) was found to be a more cost-effective treatment modality.

Economic analysis of soft-heel casting for diabetic foot ulcer: prevention and treatment.

OBJECTIVE: To model the benefit of an innovative measure to manage patients with diabetes and a foot ulcer, or at high risk of ulceration, using a soft-heel casting, which can be applied by a podiatrist or other trained staff member and used in the hospital or community setting. METHOD: An audit of the patient outcomes associated with the casting at NHS Borders was undertaken for inpatients with ulcers. These data were combined with other published data and expert opinion to model the benefit of the casting for prevention and curative purposes compared to standard practice. Cost of healed and unhealed ulcers in various settings was estimated based on the treatment pathways adopted. RESULTS: The data from the economic model suggest that soft-heel castings could reduce the costs of managing these patients by approximately 10%; about £500 per inpatient and £425 per outpatient with an ulcer, and £205 per high-risk patient, when used for prevention. CONCLUSION: This cost-consequence analysis suggests the intervention could save about 10% of costs for managing patients with an active ulcer in inpatients or outpatients and offers potential savings if used as a preventive measure. Further studies are required to confirm the estimated clinical benefit and reduced resource use.

The impact of providing product funding for compression bandaging and medical footwear on compression use, wound healing and quality of life.

A study conducted in an Australian home nursing service sought to ascertain whether the provision of funding for compression bandaging and medical footwear would impact on compression therapy use, wound healing and quality of life (QoL) among people with venous leg ulcers. Clients (n = 120) were randomly allocated to evaluation funded or not evaluation funded groups, the former provided funding for compression bandaging and medical footwear. Outcome measures included the number of wounds healed, healing rate, compression use and QoL. Analysis included ttests and Kaplan-Meier Survival Analysis. An alpha level of 0·05 classified findings as significant. There were no significant differences between groups for rate or time to healing, wounds healed or compression use. The evaluation funded group were significantly more likely to receive medical footwear. Those with confirmed diagnosis and who received multilayer bandaging, irrespective of group, achieved healing rates significantly higher than those who wore other compression therapy. Factors other than cost intervened with the capacity to evaluate the impact of wound product subsidisation. Further exploration of how to best promote evidence-based practice and future research to evaluate clinically and cost-effective wound treatments in a range of health care settings is required.

Selecting slip resistant winter footwear for personal support workers.

BACKGROUND: Falls are among the leading causes of occupational injuries for workers exposed to outdoor winter conditions such as Personal Support Workers (PSWs). Slip resistant footwear is known to reduce the risk of falls, however, it is difficult to predict how well a particular boot will perform prior to purchasing them. Our recently developed Maximum Achievable Angle (MAA) test can be used to rate footwear objectively to address this gap. OBJECTIVE: To rate the slip resistance of a selection of winter footwear that meets the needs and preferences of PSWs. METHODS: We selected 40 representative types of footwear based on survey results from 677 PSWs and applied our MAA test to rate slip resistance. RESULTS: Comfort and slip resistance were rated the most important features for selecting winter footwear. Of the 40 types of footwear tested, six were found to have a good slip resistance on ice. CONCLUSION: The vast majority of winter footwear that meet the needs and preferences of PSWs, perform poorly on ice. Therefore, PSWs should consult our website (ratemytreads.com) for selecting appropriate footwear that will keep them safe in the winter.

Do you get value for money when you buy an expensive pair of running shoes?

OBJECTIVE: This investigation aims to determine if more expensive running shoes provide better cushioning of plantar pressure and are more comfortable than low-cost alternatives from the same brand. METHODS: Three pairs of running shoes were purchased from three different manufacturers at three different price ranges: low (40-45 pounds), medium (60-65 pounds) and high (70-75 pounds). Plantar pressure was recorded with the Pedar in-shoe pressure measurement system. Comfort was assessed with a 100 mm visual analogue scale. A follow-on study was conducted to ascertain if shoe cushioning and comfort were comparable to walking while running on a treadmill. Forty-three and 9 male subjects participated in the main and follow-on studies, respectively. The main outcome measure was the evaluation of plantar pressure and comfort. RESULTS: Plantar pressure measurements were recorded from under the heel, across the forefoot and under the great toe. Differences in plantar pressure were recorded between models and between brands in relation to cost. Shoe performance was comparable between walking and running trials on a treadmill. No significant difference was observed between shoes and test occasions in terms of comfort. CONCLUSIONS: Low- and medium-cost running shoes in each of the three brands tested provided the same (if not better) cushioning of plantar pressure as high-cost running shoes. Cushioning was comparable when walking and running on a treadmill. Comfort is a subjective sensation based on individual preferences and was not related to either the distribution of plantar pressure or cost.

Off-the-shelf in-shoe heel inserts: does cost matter?

OBJECTIVE: A growing exercise culture has lead to an increase in the use of off-the-shelf heel inserts. While there are a variety of designs in a spectrum of cost ranges, probably the ease of availability and cost would mainly determine the choice of purchase. This study was designed to determine whether expensive designs provide better pressure attenuation under the heel than their less expensive counterparts. PARTICIPANTS AND DESIGN: Six brands of off-the-shelf heel inserts were tested. Selection of these was based purely on their availability in all sizes. Cost per pair ranged from 6 pounds sterling to 30 pounds sterling. Thirty-five asymptomatic subjects walked on a 10 m walkway, once with no inserts and once with each pair of inserts. The Pedar in-shoe system recorded a range of parameters under the heel. SETTING: Institute of Motion Analysis and Research, Ninewells Hospital and Medical School, University of Dundee. MAIN OUTCOME MEASURES: Evaluation of plantar pressure parameters under the heel. RESULTS: All inserts reduced peak pressure under the heel. Maximum force and pressure-time integral also decreased. Contact time generally increased with the use of inserts. Values of contact area with and without inserts were comparable. CONCLUSIONS: No significant differences were observed under the heel between the pressure attenuation properties of the lowest-priced and the most expensive designs, and hence the less expensive inserts can be considered as good as the expensive brands. However, the endurance power of these inserts may differ and this should be evaluated.

SSHeW study protocol: does slip resistant footwear reduce slips among healthcare workers? A randomised controlled trial.

INTRODUCTION: Slips, trips and falls are common causes of injuries in the workplace. It is estimated that in Great Britain, nearly 1 million days are taken off work due to these injuries. There is some evidence to suggest this accident burden could be reduced by the use of slip resistant footwear. This protocol describes a multicentre trial investigating the effectiveness and cost-effectiveness of slip resistant footwear to prevent slips in National Health Service (NHS) staff working in clinical, general or catering environments. METHODS AND ANALYSIS: A two-arm, randomised controlled trial conducted within England, with 4400 NHS staff, aged 18 years and above, who adhere to a dress code policy and work in a clinical, catering or general hospital environment. Participants will be randomised 1:1 to the intervention or waiting list control group. The intervention group will be offered a pair of 5-star GRIP rated slip resistant footwear. The control group will be offered the footwear at the end of the trial. The primary outcome is the incidence rate of self-reported slips in the workplace over a 14-week period, as reported via weekly text messages. Secondary outcomes include: time to first slip/fall, proportion of participants who slip and fall over 14 weeks and incidence rate of falls resulting from and not resulting from a slip in the workplace over 14 weeks. An economic evaluation will assess cost-effectiveness, in terms of cost per quality-adjusted life year gained. A nested qualitative study will explore the acceptability of the footwear and compliance. ETHICS AND DISSEMINATION: This protocol received a favourable ethical opinion from the University of York, Department of Health Sciences Research Governance Committee. The trial results will be published in peer-reviewed journals and at conferences. A summary of the findings will be made available to participants. TRIAL REGISTRATION NUMBER: ISRCTN33051393; Pre results.

Willingness to pay for footwear, and associated factors related to podoconiosis in northern Ethiopia.

BACKGROUND: In Northern Ethiopia, use of footwear by the rural community is limited, and non-governmental organizations provide footwear for school children as a means of preventing podoconiosis. However, this is not a sustainable strategy. This study assessed willingness to pay for footwear among people with and without podoconiosis. METHODS: A comparative cross-sectional community-based study was conducted in Mecha and Gozamen woredas among randomly selected people with and without podoconiosis. Trained health extension workers collected data using an interviewer-administered structured questionnaire. The data were entered into EPI-Data and exported to SPSS version 16.0 statistical software package for analysis. RESULTS: The willingness to pay for footwear among people with and without podoconiosis was 72.3% and 76.7% respectively (p=0.30). People with podoconiosis in the lower quintiles of economic status were less likely to be willing to pay for footwear than those in the higher quintiles. CONCLUSIONS: There is substantial willingness to pay for footwear. The expressed willingness to pay indicates demand for footwear in the community, suggesting an opportunity for shoe companies. There are still a substantial proportion of individuals not willing to pay for footwear. This requires intensified public education and social transformation to bring about change in behavior towards footwear use if elimination of podoconiosis within our generation is to be achieved.

The Therapeutic Shoe Bill: Medicare coverage for prescription footwear for diabetic patients.

This article describes the extent of coverage and the process of obtaining Medicare coverage for prescription footwear for patients with diabetes and reflects policies in effect as of April 1, 2004.

Evaluation of the costs to Medicare of covering therapeutic shoes for diabetic patients.

OBJECTIVE: A three-year demonstration was fielded in three states to evaluate the cost to Medicare of a therapeutic shoes benefit for Medicare Part B beneficiaries with severe diabetic foot disease. RESEARCH DESIGN AND METHODS: Eligible Medicare beneficiaries who applied were randomly assigned to either a treatment group that received the extra therapeutic shoe coverage or a control group that received only standard Medicare coverage. This study analyzes the Medicare payments and service use of 3,428 demonstration participants in California, Florida, and New York for whom data on a 12-month follow-up period were available. These results are comparable to those for the entire sample over a variable length follow-up period that averaged 20 months but ranged from 3 months to 3 years. RESULTS: Differences between groups are not statistically significant. However, Medicare payments for all services among the treatment group were $451 (3.8%) higher than those for all services among the control group. Similarly, Medicare payments for foot-care services were $318 (14.6%) higher among beneficiaries in the treatment group, which considerably exceeded the cost of the shoe benefit ($118). CONCLUSIONS: The demonstration produced no definitive evidence that expanding Medicare Part B to cover therapeutic shoes for beneficiaries with severe diabetic foot disease would increase total Medicare costs. However, our findings indicate that the demonstration was successful at increasing therapeutic shoe ownership and was instrumental in increasing beneficiaries' use of the shoes when walking outdoors.

Motivational brochures increase the number of medicare-eligible persons with diabetes making therapeutic footwear claims.

OBJECTIVE: This study tests the hypothesis that Medicare beneficiaries at high risk of foot complications who are mailed a motivational brochure describing the Medicare diabetes-related therapeutic footwear benefit will increase their therapeutic footwear-related Medicare claims. RESEARCH DESIGN AND METHODS: In this quasi-experimental study, a motivational brochure was mailed in the summer of 1997 to 5,872 Medicare beneficiaries in Washington, Alaska, and Idaho who were identified as being at high risk for foot-related claims on the basis of their prior Medicare claims history. Beneficiaries were identified through footwear claims made in these states-and also in three comparison states (Oregon, Montana, and Wyoming)-during the 18 months before and after the mailing. Linear regression was used to compare the number of persons making claims in the intervention states with the comparison states before, at the time of, and after the mailing. RESULTS: Before the intervention, the number of persons making claims was increasing in the non-intervention states and decreasing in the intervention states. During the first month after the intervention mailing, the number of persons making claims remained nearly the same in non-intervention states, but increased 13 persons per month in intervention states (95% CI 3.5-11 persons/month). After the intervention, the number of persons making claims continued to increase similarly in both intervention and non-intervention states. CONCLUSIONS: Mailed motivational brochures were associated with an increase in the number of persons making therapeutic footwear claims. Randomized trials should confirm these findings.

Potential economic benefits of lower-extremity amputation prevention strategies in diabetes.

OBJECTIVE: To estimate the potential economic benefits of selected strategies from published literature--educational interventions, multidisciplinary clinics, and insurance coverage for therapeutic shoes--to reduce the incidence of lower-extremity amputation among individuals with diabetes. RESEARCH DESIGN AND METHODS: We developed a model to estimate the expected incidence and associated costs of lower-extremity amputation in a hypothetical cohort of 10,000 people with diabetes. Prevention strategies were assumed to be targeted at individuals with a history of foot ulcer, and benefits were estimated over a period of 3 years. RESULTS: The total potential economic benefits (discounted at 5%) of strategies to reduce amputation risk ranged from $2.0 to $3.0 million ($2,900 to $4,442 per person with a history of foot ulcer) over 3 years. Benefits were highest for educational interventions. Most benefits were found to accrue among individuals aged > or = 70 years. CONCLUSIONS: Strategies to reduce the risk of lower-extremity amputation may generate substantial economic benefits and should be a standard component of routine diabetes care. Benefits may best be achieved through a partnership of government, private payers, health care service providers and producers, and individuals with diabetes.

Purchasing infant shoes: attitudes of parents, pediatricians, and store managers.

Questionnaires designed to collect data about the purchase of shoes for normal infants were completed by 104 parents in a university ambulatory unit, 127 practicing pediatricians, and 36 shoe store managers. Infants received their first pair of walking shoes at an average age of 8.1 months (range: 4 to 12 months) and at an average cost of $14.56 (range: $2 to $43). Most of these shoes had laces (95%), high tops (87%), hard soles (74%), and special arch supports (50%). Of the 104 children, 73 had shoes before they were walking (average cost: $13.21) and 35 wore walking shoes before they were even standing (average cost: $12.68). Parents obtained much more information about shoes from friends and relatives than from physicians. Those parents who obtained most of their information from salespersons spent the most for shoes. The average cost of shoes recommended by store managers was $18.74. Although 77% of pediatricians felt that inexpensive canvas sneakers are adequate, only 28% of the salespersons and 37% of the parents believed that wearing sneakers is healthy.

Cost-effective footwear for leprosy control programmes: a study in rural Ethiopia.

A randomized, controlled trial of commercially available canvas shoes was carried out in a rural area of Ethiopia. Subjects with deformed and anaesthetic feet, most with ulceration, were given either canvas shoes or plastazote/moulded shoes and followed up for one year. Seventy-five percent of subjects with ulcers who used canvas shoes had no ulcer at the end of the study, while no significant change was noted in the plastazote group. The durability and acceptability of the shoes were also examined. Clients in remote areas who have no access to an orthopaedic workshop, but who have anaesthetic feet, with or without deformity, should have access to canvas shoes with an MCR insole. Two pairs are needed per year at a cost of US$6.7 per pair.

American Orthopaedic Foot and Ankle Society shoe survey of diabetic patients.

A one-page written survey was completed by 402 randomly selected patients with diabetes in five cities during a scheduled visit to their endocrinologist. Patients averaged 61.5 years of age and had been diagnosed with diabetes for 27.3 years. This study suggests that approximately 25% of adults with diabetes are at risk for developing foot ulcers, the precursor to deep infection leading to lower limb amputation. The goal at the inception of this project was to obtain benchmark data on the current level of prophylactic foot care being provided to adult patients with diabetes. The results of this survey suggest that most individuals with diabetes and their physicians are aware of potential diabetic foot morbidity, yet very few take advantage of prophylactic protective footware. Even fewer are presently taking advantage of benefits established through the Medicare Therapeutic Foot Bill. This survey highlights a substantial opportunity for improvement in the long-term care of individuals with diabetes.

Orthopedic footwear. Custom-made and commercially manufactured footwear.

Shoes and footwear have been a part of human lives for centuries. Many take good foot health for granted. For those individuals, the commercial shoe store has hundreds of varieties of shoes in every price range. For individuals with compromised, at-risk feet, the options are reduced greatly. The foot health industry today has made available many viable options to meet specific needs. Footwear can augment successfully the treatment of foot and ankle pathology and when properly applied improve the health and lifestyle of patients.

Household-shoe wearing and purchasing habits. A survey of people aged 65 years and older.

A mail survey was conducted to assess the types of household footwear currently being worn by a random sample of independently living men and women aged 65 years and older as well as their needs related to the purchase and wearing of household footwear. Questionnaires were completed by 128 people. The greatest number of respondents wore slippers all day around the home, purchasing these shoes because of their convenience and comfort. Respondents were not willing to purchase expensive shoes for household wear and infrequently replaced them, despite the fact that such footwear was worn for extended periods each day. It was concluded that further research is required to design a household shoe that fits well and accommodates a variety of foot pathologies typical of the elderly foot; the shoe should be comfortable, relatively inexpensive, and safe for typical household surfaces.

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.