Should weight-bearing activity be reduced during healing of plantar diabetic foot ulcers, even when using appropriate offloading devices?

Physical activity is an essential part of general health and diabetes management. However, recommending weight-bearing physical activity for people with plantar diabetic foot ulcers is controversial, even when gold standard offloading devices are used, as it is commonly thought to delay healing. We aimed to narratively review relevant studies investigating the relationship between plantar diabetic foot ulcer healing and weight-bearing activity, plantar pressure and device adherence. We defined relevant studies as those from two systematic reviews, along with those identified since using a similar updated Pubmed search strategy. We identified six studies. One study found that more daily steps were associated with worse ulcer healing, three found no significant association between steps and ulcer healing, and in two others the association was unclear. Thus, there is weak evidence for an inverse relationship between weight-bearing physical activity and plantar ulcer healing while utilizing offloading devices. We propose a Diabetic foot Offloading and Activity framework to guide future research to find the optimal balance between the positive and negative effects of weight-bearing activity in the context of foot ulcers. We hope such future studies will shed more conclusive light on the impact of weight-bearing activity on healing of plantar diabetic foot ulcers

A model of access combining triage with initial management reduced waiting time for community outpatient services: a stepped wedge cluster randomised controlled trial

BACKGROUND: Long waiting times are associated with public community outpatient health services. This trial aimed to determine if a new model of care based on evidence-based strategies that improved patient flow in two small pilot trials could be used to reduce waiting time across a variety of services. The key principle of the Specific Timely Appointments for Triage (STAT) model is that patients are booked directly into protected assessment appointments and triage is combined with initial management as an alternative to a waiting list and triage system. METHODS: A stepped wedge cluster randomised controlled trial was conducted between October 2015 and March 2017, involving 3116 patients at eight sites across a major Australian metropolitan health network. RESULTS: The intervention reduced waiting time to first appointment by 33.8% (IRR = 0.663, 95% CI 0.516 to 0.852, P = 0.001). Median waiting time decreased from a median of 42 days (IQR 19 to 86) in the control period to a median of 24 days (IQR 13 to 48) in the intervention period. A substantial reduction in variability was also noted. The model did not impact on most secondary outcomes, including time to second appointment, likelihood of discharge by 12 weeks and number of appointments provided, but was associated with a small increase in the rate of missed appointments. CONCLUSIONS: Broad-scale implementation of a model of access and triage that combined triage with initial management and actively managed the relationship between supply and demand achieved substantial reductions in waiting time without adversely impacting on other aspects of care. The reductions in waiting time are likely to have been driven, primarily, by substantial reductions for those patients previously considered low priority. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615001016527 registration date: 29/09/2015

Risk för fotsår vid diabetes : Är objektiva riskfaktorer associerade med upplevd risk?

Foot ulcers are a common and difficult complication of diabetes, and can end with amputation of the foot. Although some patients fear amputation more than death, adherence to self-care to prevent ulceration is generally low. This raises the question about how people at risk of foot ulcerations perceive risks. The aim the thesis is to explore whether people with and without known risk factors for foot ulcerations (male gender, previous foot ulcer, and previous amputation) experience different levels of probability of developing foot ulcers the coming 12 months. A questionnaire was sent to 1230 patients at two prosthetics and orthotics clinics in Örebro and Gothenburg. 443 responses were included in the analysis. The association between each risk factor and perceived risk of foot ulcer was investigated with a Mann-Whitney test and Chi-square test. Subsequently, all risk factors were included in a multiple logistic regression analysis with perceived foot ulcer risk as the dependent variable. The Mann-Whitney test and Chi-square test showed that people with previous foot ulcers experienced significantly higher risk (p<0.05) than people without previous foot ulcers and people with amputation experienced higher risk than people without amputation. Gender was not significantly associated with perceived foot ulcer risk. In the logistic regression analysis, previous foot ulcer was significantly associated with higher perceived risk of future foot ulcers, while sex and amputation were not significant. Presumably, amputation was not significant in the logistic regression analysis because there was a strong association between previous foot ulcer and amputation. The model explained only 8,3 % of the variance in perceived foot ulcer risk, which indicates that there may be several other factors affecting perceived risk of foot ulcers. The lack of significant association between sex and perceived risk can be interpreted as an optimism bias among men and/or a pessimism bias among women, which would be interesting to investigate further in future research. Future studies should use more precise methods to measure subjective risk, measure the negative value of foot ulcers and investigate interventions to promote a more realistic perception of risk to promote self-care and reduce risk of foot ulcer.

Risk för fotsår vid diabetes : Är objektiva riskfaktorer associerade med upplevd risk?

Foot ulcers are a common and difficult complication of diabetes, and can end with amputation of the foot. Although some patients fear amputation more than death, adherence to self-care to prevent ulceration is generally low. This raises the question about how people at risk of foot ulcerations perceive risks. The aim the thesis is to explore whether people with and without known risk factors for foot ulcerations (male gender, previous foot ulcer, and previous amputation) experience different levels of probability of developing foot ulcers the coming 12 months. A questionnaire was sent to 1230 patients at two prosthetics and orthotics clinics in Örebro and Gothenburg. 443 responses were included in the analysis. The association between each risk factor and perceived risk of foot ulcer was investigated with a Mann-Whitney test and Chi-square test. Subsequently, all risk factors were included in a multiple logistic regression analysis with perceived foot ulcer risk as the dependent variable. The Mann-Whitney test and Chi-square test showed that people with previous foot ulcers experienced significantly higher risk (p<0.05) than people without previous foot ulcers and people with amputation experienced higher risk than people without amputation. Gender was not significantly associated with perceived foot ulcer risk. In the logistic regression analysis, previous foot ulcer was significantly associated with higher perceived risk of future foot ulcers, while sex and amputation were not significant. Presumably, amputation was not significant in the logistic regression analysis because there was a strong association between previous foot ulcer and amputation. The model explained only 8,3 % of the variance in perceived foot ulcer risk, which indicates that there may be several other factors affecting perceived risk of foot ulcers. The lack of significant association between sex and perceived risk can be interpreted as an optimism bias among men and/or a pessimism bias among women, which would be interesting to investigate further in future research. Future studies should use more precise methods to measure subjective risk, measure the negative value of foot ulcers and investigate interventions to promote a more realistic perception of risk to promote self-care and reduce risk of foot ulcer.

A model to facilitate implementation of the International Classification of Functioning, Disability and Health into prosthetics and orthotics

BACKGROUND: The International Classification of Functioning, Disability and Health is a classification of human functioning and disability and is based on a biopsychosocial model of health. As such, International Classification of Functioning, Disability and Health seems suitable as a basis for constructing models defining the clinical P&O process. The aim was to use International Classification of Functioning, Disability and Health to facilitate development of such a model. Proposed model: A model, the Prosthetic and Orthotic Process (POP) model, is proposed. The Prosthetic and Orthotic Process model is based on the concepts of the International Classification of Functioning, Disability and Health and comprises four steps in a cycle: (1) Assessment, including the medical history and physical examination of the patient. (2) Goals, specified on four levels including those related to participation, activity, body functions and structures and technical requirements of the device. (3) Intervention, in which the appropriate course of action is determined based on the specified goal and evidence-based practice. (4) Evaluation of outcomes, where the outcomes are assessed and compared to the corresponding goals. After the evaluation of goal fulfilment, the first cycle in the process is complete, and a broad evaluation is now made including overriding questions about the patient's satisfaction with the outcomes and the process. This evaluation will determine if the process should be ended or if another cycle in the process should be initiated. CONCLUSION: The Prosthetic and Orthotic Process model can provide a common understanding of the P&O process. Concepts of International Classification of Functioning, Disability and Health have been incorporated into the model to facilitate communication with other rehabilitation professionals and encourage a holistic and patient-centred approach in clinical practice. Clinical relevance The Prosthetic and Orthotic Process model can support the implementation of International Classification of Functioning, Disability and Health in P&O practice, thereby providing a common understanding of the P&O process and a common language to facilitate communication with other rehabilitation professionals

An innovative sealed shoe to off-load and heal diabetic forefoot ulcers – a feasibility study

Background: Non-removable knee-high devices are the gold standard to treat diabetic foot ulcers located on the plantar forefoot, but they immobilize the ankle, which restricts daily life activities and has negative effects on joint functioning. Objective: To investigate the feasibility of sealing a therapeutic shoe to off-load and heal diabetic forefoot ulcers. Design: A case series of seven men with type 2 diabetes and a metatarsal head ulcer were prescribed therapeutic shoes and custom-made insoles. The shoe was sealed with a plastic band. Off-loading was assessed with the F-scan pressure measurement system. Adherence to wearing the shoe was assessed with a temperature sensor and by documenting the status of the seal. Results: The off-loading was effective and all ulcers healed. Median time to healing was 56 days (range 8–160). Complications were secondary ulcer (n = 1) and plantar hematoma (n = 1). Five of seven participants did not disturb the seal. Conclusions: Sealing a therapeutic shoe is a feasible way to off-load and heal forefoot ulcers. A controlled trial is needed to compare the effectiveness and safety of a sealed shoe to other non-removable devices

Knee-high devices are gold in closing the foot ulcer gap : A review of offloading treatments to heal diabetic foot ulcers

Diabetic foot ulcers (DFU) are a leading cause of the global disease burden. Most DFUs are caused, and prolonged, by high plantar tissue stress under the insensate foot of a person with peripheral neuropathy. Multiple different offloading treatments have been used to try to reduce high plantar tissue stress and heal DFUs, including bedrest, casting, offloading devices, footwear, and surgical procedures. The best offloading treatments are those that balance the benefits of maximizing reductions in high plantar tissue stress, whilst reducing the risks of poor satisfaction, high costs and potential adverse events outcomes. This review aimed to summarize the best available evidence on the effects of offloading treatments to heal people with DFUs, plus review their use in clinical practice, the common barriers and solutions to using these treatments, and discuss promising emerging solutions that may improve offloading treatments in future. Findings demonstrate that knee-high offloading devices, non-removable or removable knee-high devices worn for all weight-bearing activities, are the gold standard offloading treatments to heal most patients with DFU, as they are much more effective, and typically safer, quicker, and cheaper to use compared with other offloading treatments. The effectiveness of offloading treatments also seems to increase when increased offloading mechanical features are incorporated within treatments, including customized insoles, rocker-bottom soles, controlled ankle motion, and higher cast walls. However, in clinical practice these gold standard knee-high offloading devices have low rates of prescription by clinicians and low rates of acceptance or adherence by patients. The common barriers resulting in this low use seem to surround historical misperceptions that are mostly dispelled by contemporary evidence. Further, research is now urgently required to close the implementation gap between the high-quality of supporting evidence and the low use of knee-high devices in clinical practice to reduce the high global disease burden of DFU in future.</p

Translation and linguistic validation of the Swedish version of “Orthotics and Prosthetics Users’ Survey” (OPUS)

There is a lack of valid Swedish instruments to assess the overall outcome of upper limb prosthetic treatment. The Orthotic and Prosthetic Users’ Survey (OPUS) consists of five questionnaires assessing common goals in prosthetic and orthotic practice. The OPUS measures health related quality of life, satisfaction with device and services, respectively, and functional status of upper and lower extremities, respectively. Hence, this instrument could be a useful tool for outcome assessment of Swedish practice. Following the guidelines by the World Health Organization, the questionnaires were translated to Swedish and validated linguistically. Thirty-nine persons (12 men, 27 women) representing the target groups for OPUS participated in the study. During a regular visit at the prosthetic-orthotic out-patient clinic, the participants answered the relevant questionnaires and were systematically debriefed immediately afterwards. In most cases the items were understood as intended. In a few cases words and expressions had to be changed to avoid misunderstandings or diverse interpretations of the items. The resulting Swedish version of OPUS showed acceptable linguistic validity. A study on construct validity and reliability of the Swedish OPUS is in process and preliminary results will be presented

Gender differences in attitudes and attributes of people using therapeutic shoes for diabetic foot complications

Abstract Background Therapeutic shoes can prevent diabetic foot reulcerations but their use is complicated by the fact that shoes have psychological and social meanings, which is believed to put a larger burden on women than men. The aim was to compare attitudes and attributes of women and men using therapeutic shoes for diabetic foot complications. Methods A questionnaire was posted to 1230 people with diabetes who had been fitted with therapeutic shoes. Women’s and men’s answers were compared using t-tests, Mann–Whitney U tests and chi-square tests with Fischer’s exact tests. P-values < 0.05 were considered statistically significant. Results Questionnaires from 443 (36.0%) respondents (294 men, 149 women, mean age 69.2 years) were analyzed. More men than women (p < 0.05) had paid employment (20.4% vs 9.4%), had someone who reminded them to wear their therapeutic shoes (27.6% vs 10.0%), and had a history of foot ulcers (62.9% vs 46.3%) or minor amputation (17.7% vs 6.7%). More women than men received disability pension (18.8% vs 10.2%). Women reported worse general health, lower internal locus of control regarding ulcer prevention, and more negative attitudes to the appearance and price of therapeutic shoes and how they felt about wearing them in public. Other comparisons were non-significant: other shoe attributes, education, diabetes type, current foot ulcers, major amputations, satisfaction with shoe services, understanding of neuropathy as a risk factor, locus of control regarding ulcer healing, belief in the shoes’ efficacy to prevent and heal ulcers, worries about ulcer healing and new ulcerations, self-efficacy, depression, shoe use/adherence, paying a fee for therapeutic shoes, and social support. Conclusions Men had worse foot complications. Women had worse general health, lower internal locus of control regarding ulcer prevention, and more negative attitudes toward therapeutic shoes. Clinicians should pay more attention to their female patients’ concerns. Future research and development should focus on improving the weight and appearance of therapeutic shoes, particularly for women. Research is also needed on how to facilitate the adaption and reevaluation process where patients change from viewing shoes purely as items of clothing to also viewing them as medical interventions