Randomized Controlled Trial Comparing the Effects of Far-Infrared Emitting Ceramic Fabric Shirts and Control Polyester Shirts on Transcutaneous PO2.

Our aim was to confirm earlier studies showing tcPO2 to be higher under clothing made with polyethylene terephalate (PET) fabric containing ceramic particles (CEL) compared to standard PET fabric. In previous studies PET garments were donned first to avoid possible persistent effects from ceramic particles. This study randomized donning sequence to avoid bias. METHODS: Subjects were randomized to don either PET shirts first (PETF n=73) or CEL first (CELF n=80), switching garments after 90 minutes. Skin temperature (ST), arterial oxygen saturation (O2sat), and tcPO2 were measured every 30 minutes. RESULTS: Baseline ST and O2 sat were nearly identical in the two groups. Baseline tcPO2 was modestly higher in the CELF group than with PETF: 66.4 ± 18.9 vs. 63.9 ± 18.8 mmHg (n.s). Independent of donning sequence, tcPO2 measurements 90 minutes after wearing CEL were 6.7% higher than after 90 minutes wearing PET (p<0.0003). Sequence analysis found tcPO2 in PETF subjects to gradually rise before and after switching garments, but tcPO2 fell immediately after switching garments in CELF subjects. PETF baseline O2sat of 98.1 ± 1.3 increased insignificantly after 90 minutes, and then increased further to 98.6 ± 0.8 after wearing CEL ninety minutes (p=0.0001). CELF baseline O2sat of 97.9 ± 1.7 increased to 98.5 ± 1.1 90 minutes after donning CEL (p=0.0002) and fell to 98.3 ± 1.0 ninety minutes after switching to PET (p=0.0033). CONCLUSIONS: The ability of ceramic-embedded fabric to induce higher tcPO2 measurements is not due to sequence bias.

Prevention of foot ulcers in the at-risk patient with diabetes: a systematic review.

BACKGROUND: Prevention of foot ulcers in patients with diabetes is extremely important to help reduce the enormous burden of foot ulceration on both patient and health resources. A comprehensive analysis of reported interventions is not currently available, but is needed to better inform caregivers about effective prevention. The aim of this systematic review is to investigate the effectiveness of interventions to prevent first and recurrent foot ulcers in persons with diabetes who are at risk for ulceration. METHODS: The available medical scientific literature in PubMed, EMBASE, CINAHL and the Cochrane database was searched for original research studies on preventative interventions. Both controlled and non-controlled studies were selected. Data from controlled studies were assessed for methodological quality by two independent reviewers. RESULTS: From the identified records, a total of 30 controlled studies (of which 19 RCTs) and another 44 non-controlled studies were assessed and described. Few controlled studies, of generally low to moderate quality, were identified on the prevention of a first foot ulcer. For the prevention of recurrent plantar foot ulcers, multiple RCTs with low risk of bias show the benefit for the use of daily foot skin temperature measurements and consequent preventative actions, as well as for therapeutic footwear that demonstrates to relieve plantar pressure and that is worn by the patient. To prevent recurrence, some evidence exists for integrated foot care when it includes a combination of professional foot treatment, therapeutic footwear and patient education; for just a single session of patient education, no evidence exists. Surgical interventions can be effective in selected patients, but the evidence base is small. CONCLUSION: The evidence base to support the use of specific self-management and footwear interventions for the prevention of recurrent plantar foot ulcers is quite strong, but is small for the use of other, sometimes widely applied, interventions and is practically nonexistent for the prevention of a first foot ulcer and non-plantar foot ulcer.

Interventions in the management of infection in the foot in diabetes: a systematic review.

The expert panel on diabetic foot infection (DFI) of the International Working Group on the Diabetic Foot conducted a systematic review seeking all published reports relating to any type of treatment for infection of the foot in persons with diabetes published as of 30 June 2014. This review, conducted with both PubMed and EMBASE, was used to update an earlier one undertaken on 30 June 2010 using the same search string. Eligible publications included those that had outcome measures reported for both a treated and a control population that were managed either at the same time, or as part of a before-and-after case design. We did not include studies that contained only information related to definition or diagnosis, but not treatment, of DFI. The current search identified just seven new articles meeting our criteria that were published since the 33 identified with the previous search, making a total of 40 articles from the world literature. The identified articles included 37 randomised controlled trials (RCTs) and three cohort studies with concurrent controls, and included studies on the use of surgical procedures, topical antiseptics, negative pressure wound therapy and hyperbaric oxygen. Among the studies were 15 RCTs that compared outcomes of treatment with new antibiotic preparations compared with a conventional therapy in the management of skin and soft tissue infection. In addition, 10 RCTs and 1 cohort study compared different treatments for osteomyelitis in the diabetic foot. Results of comparisons of different antibiotic regimens generally demonstrated that newly introduced antibiotic regimens appeared to be as effective as conventional therapy (and also more cost-effective in one study), but one study failed to demonstrate non-inferiority of a new antibiotic compared with that of a standard agent. Overall, the available literature was both limited in both the number of studies and the quality of their design. Thus, our systematic review revealed little evidence upon which to make recommendations for treatment of DFIs. There is a great need for further well-designed trials that will provide robust data upon which to make decisions about the most appropriate treatment of both skin and soft tissue infection and osteomyelitis in diabetic patients.

The microbiome of diabetic foot osteomyelitis.

The purpose of this investigation was to evaluate the diversity of bacteria in diabetic foot osteomyelitis using a 16S rRNA sequencing approach and to compare the results with conventional culture techniques. In this prospective observational study, we obtained 34 bone samples from patients admitted to our hospital with a moderate-severe diabetic foot infection. We analysed the distribution of the 16S rRNA gene sequences in the bone samples, using an Illumina MiSeq Personal Sequencer. We compared the genera that were detected with the cultured pathogens in the bone samples with conventional techniques. In the 23 samples that had positive results with both techniques, Staphylococcus, Corynebacterium, Streptococcus and Propionibacterium spp. were detected in 20, 18, 13 and 11 samples, respectively. Significantly more anaerobes were detected with 16S rRNA sequencing compared to conventional techniques (86.9 % vs. 23.1 %, p = 0.001) and more Gram-positive bacilli were present (78.3 % vs. 3.8 %, p < 0.001). Staphylococcus spp. were identified in all of the sequenced bone samples that were negative with conventional techniques. Mixed genera were present in 83.3 % (5 of 6) of the negative samples. Anaerobic and fastidious organisms may play a more significant role in osteomyelitis than previously reported. Further studies with larger populations are needed in order to fully understand the clinical importance of the microbial diversity of diabetic foot osteomyelitis.

Electrospun nitric oxide releasing bandage with enhanced wound healing.

Research has shown that nitric oxide (NO) enhances wound healing. The incorporation of NO into polymers for medical materials and surgical devices has potential benefits for many wound healing applications. In this work, acrylonitrile (AN)-based terpolymers were electrospun to form non-woven sheets of bandage or wound dressing type materials. NO is bound to the polymer backbone via the formation of a diazeniumdiolate group. In a 14 day NO release study, the dressings released 79 µmol NO g(-1) polymer. The NO-loaded dressings were tested for NO release in vivo, which demonstrate upregulation of NO-inducible genes with dressing application compared to empty dressings. Studies were also conducted to evaluate healing progression in wounds with dressing application performed weekly and daily. In two separate studies, excisional wounds were created on the dorsa of 10 mice. Dressings with NO loaded on the fibers or empty controls were applied to the wounds and measurements of the wound area were taken at each dressing change. The data show significantly enhanced healing progression in the wounds with weekly NO application, which is more dramatic with daily application. Further, the application of daily NO bandages results in improved wound vascularity. These data demonstrate the potential for this novel NO-releasing dressing as a valid wound healing therapy.

Approaches to learning for the ANZCA Final Examination and validation of the revised Study Process Questionnaire in specialist medical training.

When evaluating assessments, the impact on learning is often overlooked. Approaches to learning can be deep, surface and strategic. To provide insights into exam quality, we investigated the learning approaches taken by trainees preparing for the Australian and New Zealand College of Anaesthetists (ANZCA) Final Exam. The revised two-factor Study Process Questionnaire (R-SPQ-2F) was modified and validated for this context and was administered to ANZCA advanced trainees. Additional questions were asked about perceived value for anaesthetic practice, study time and approaches to learning for each exam component. Overall, 236 of 690 trainees responded (34%). Responses indicated both deep and surface approaches to learning with a clear preponderance of deep approaches. The anaesthetic viva was valued most highly and the multiple choice question component the least. Despite this, respondents spent the most time studying for the multiple choice questions. The traditionally low short answer questions pass rate could not be explained by limited study time, perceived lack of value or study approaches. Written responses suggested that preparation for multiple choice questions was characterised by a surface approach, with rote memorisation of past questions. Minimal reference was made to the ANZCA syllabus as a guide for learning. These findings indicate that, although trainees found the exam generally relevant to practice and adopted predominantly deep learning approaches, there was considerable variation between the four components. These results provide data with which to review the existing ANZCA Final Exam and comparative data for future studies of the revisions to the ANZCA curriculum and exam process.

A systematic review of the effectiveness of interventions in the management of infection in the diabetic foot.

The International Working Group on the Diabetic Foot expert panel on infection conducted a systematic review of the published evidence relating to treatment of foot infection in diabetes. Our search of the literature published prior to August 2010 identified 7517 articles, 29 of which fulfilled predefined criteria for detailed data extraction. Four additional eligible papers were identified from other sources. Of the total of 33 studies, 29 were randomized controlled trials, and four were cohort studies. Among 12 studies comparing different antibiotic regimens in the management of skin and soft-tissue infection, none reported a better response with any particular regimen. Of seven studies that compared antibiotic regimens in patients with infection involving both soft tissue and bone, one reported a better clinical outcome in those treated with cefoxitin compared with ampicillin/sulbactam, but the others reported no differences between treatment regimens. In two health economic analyses, there was a small saving using one regimen versus another. No published data support the superiority of any particular route of delivery of systemic antibiotics or clarify the optimal duration of antibiotic therapy in either soft-tissue infection or osteomyelitis. In one non-randomized cohort study, the outcome of treatment of osteomyelitis was better when the antibiotic choice was based on culture of bone specimens as opposed to wound swabs, but this study was not randomized, and the results may have been affected by confounding factors. Results from two studies suggested that early surgical intervention was associated with a significant reduction in major amputation, but the methodological quality of both was low. In two studies, the use of superoxidized water was associated with a better outcome than soap or povidone iodine, but both had a high risk of bias. Studies using granulocyte-colony stimulating factor reported mixed results. There was no improvement in infection outcomes associated with hyperbaric oxygen therapy. No benefit has been reported with any other intervention, and, overall, there are currently no trial data to justify the adoption of any particular therapeutic approach in diabetic patients with infection of either soft tissue or bone of the foot.

Expert opinion on the management of infections in the diabetic foot.

This update of the International Working Group on the Diabetic Foot incorporates some information from a related review of diabetic foot osteomyelitis (DFO) and a systematic review of the management of infection of the diabetic foot. The pathophysiology of these infections is now well understood, and there is a validated system for classifying the severity of infections based on their clinical findings. Diagnosing osteomyelitis remains difficult, but several recent publications have clarified the role of clinical, laboratory and imaging tests. Magnetic resonance imaging has emerged as the most accurate means of diagnosing bone infection, but bone biopsy for culture and histopathology remains the criterion standard. Determining the organisms responsible for a diabetic foot infection via culture of appropriately collected tissue specimens enables clinicians to make optimal antibiotic choices based on culture and sensitivity results. In addition to culture-directed antibiotic therapy, most infections require some surgical intervention, ranging from minor debridement to major resection, amputation or revascularization. Clinicians must also provide proper wound care to ensure healing of the wound. Various adjunctive therapies may benefit some patients, but the data supporting them are weak. If properly treated, most diabetic foot infections can be cured. Providers practising in developing countries, and their patients, face especially challenging situations.

Mortality and cause of death in mucopolysaccharidosis type II-a historical review based on data from the Hunter Outcome Survey (HOS).

Mucopolysaccharidosis type II (MPS II or Hunter syndrome) is a progressive, multisystemic disease caused by a deficiency of iduronate-2-sulfatase. Patients with the severe form of the disease have cognitive impairment and typically die in the second decade of life. Patients with the less severe form do not experience significant cognitive involvement and may survive until the fifth or sixth decade of life. We studied the relationship of both severity of MPS II and the time period in which patients died with age at death in 129 patients for whom data were entered retrospectively into HOS (Hunter Outcome Survey), the only large-scale, multinational observational study of patients with MPS II. Median age at death was significantly lower in patients with cognitive involvement compared with those without cognitive involvement (11.7 versus 14.1 years; p = 0.024). These data indicate that cognitive involvement is indicative of more severe disease and lower life expectancy in patients with MPS II. Median age at death was significantly lower in patients who died in or before 1985 compared with those who died after 1985 (11.3 versus 14.1 years; p alpha 0.001). The difference in age at death between patients dying in or before, relative to after, the selected cut-off date of 1985 may reflect improvements in patient identification, care and management over the past two decades. Data from patients who died after 1985 could serve as a control in analyses of the effects of enzyme replacement therapy with idursulfase on mortality in patients with MPS II.

Functional status of persons with diabetes-related lower-extremity amputations.

OBJECTIVE: It is reasonable to predict that diabetes-related lower-extremity amputations have a detrimental impact on quality of life. However, we are unaware of any study in the medical literature describing the functional level of diabetic patients with amputations. The objective of this study was to evaluate amputations among diabetic patients and to determine the functional level of these patients with the Sickness Impact Profile (SIP). RESEARCH DESIGN AND METHODS: We enrolled 124 patients with diabetes. Case subjects (n = 35) were defined as patients who had undergone amputation of the lower-extremity, and control subjects (n = 89) were defined as patients who had not undergone amputation. Study participants received a standard history and physical examination. RESULTS: Both the physical dimension scores (33.5 +/- 14.9 vs. 22.3 +/- 14.7, P < 0.001) and the total SIP scores (27.6 +/- 9.9 vs. 22.5 +/- 10.3, P = 0.013) were significantly higher for amputees. However, the psychosocial dimension scores were not significantly different between case and control subjects (14.9 +/- 8.9 vs. 15.2 +/- 10.0, P > 0.05). Post hoc analysis showed that the group of patients who had undergone transtibial amputation had a significantly higher total impairment score than patients who had not undergone amputation (P = 0.039). This is in contrast to patients with toe or midfoot amputations, for whom total impairment scores were not significantly higher than those for the control subjects. Interestingly, bilateral amputees did not have significantly higher scores on either SIP dimension compared with unilateral amputees. CONCLUSIONS: These findings exemplify the detrimental physical and psychosocial health status of patients with diabetes-related lower-extremity amputation.

Effectiveness of the diabetic foot risk classification system of the International Working Group on the Diabetic Foot.

OBJECTIVE: To evaluate the effectiveness of a diabetic foot risk classification system by the International Working Group on the Diabetic Foot to predict clinical outcomes. RESEARCH DESIGN AND METHODS: A total of 225 diabetic patients were initially evaluated as part of a prospective case-control study at the University of Texas Health Science Center at San Antonio. Complete records were available for 213 patients for follow-up evaluation after 29 months. Upon enrollment, subjects were stratified into four risk groups based on the presence of risk factors according to the consensus of the International Working Group on the Diabetic Foot. Group 0 consisted of subjects without neuropathy, group 1 consisted of patients with neuropathy but without deformity or peripheral vascular disease (PVD), group 2 consisted of subjects with neuropathy and deformity or PVD, and group 3 consisted of patients with a history of foot ulceration or a lower-extremity amputation. RESULTS: Upon enrollment, patients in higher-risk groups had longer duration of diabetes, worse glycemic control, vascular and neuropathic variables, and more systemic complications of diabetes. During 3 years of follow-up, ulceration occurred in 5.1, 14.3, 18.8, and 55.8% of the patients in groups 0, 1, 2, and 3, respectively (linear-by-linear association, P < 0.001). All amputations were found in Groups 2 and 3 (3.1 and 20.9%, P < 0.001). CONCLUSIONS: The foot risk classification of the International Working Group on the Diabetic Foot predicts ulceration and amputation and can function as a tool to prevent lower-extremity complications of diabetes.

A comparison of diabetic foot ulcer patients managed in VHA and non-VHA settings.

OBJECTIVE: To compare patients with diabetes and new onset foot ulcers treated in Veterans Health Administration (VHA) and non-VHA settings. METHODS: The treatment of patients with new onset diabetic foot ulcers was prospectively monitored in three VHA and three non-VHA hospitals and outpatient settings until ulcer healing, amputation, or death. RESULTS: Of the 302 individuals enrolled in this study, 47% were veterans receiving VHA care. There were no significant differences between veterans and nonveterans in baseline wound classification, diabetes severity, or comorbid conditions. Veterans received significantly fewer sharp debridements, total contact casts, and custom inserts than their nonveteran counterparts, and they had significantly more x-rays, local saline irrigations, IV antibiotics, and prescriptions for bed rest. The percentage of amputations was higher in veterans but did not achieve statistical significance. CONCLUSIONS: Many commonly held stereotypes of veteran men were not found. Veterans and nonveterans with foot ulcers were similar in terms of health and foot history, diabetes severity, and comorbid conditions. There was considerable variation in treatment of diabetic foot ulcers between VHA and non-VHA care. Yet this variation did not result in statistically significant differences in ulcer outcomes.

Electric stimulation as an adjunct to heal diabetic foot ulcers: a randomized clinical trial.

OBJECTIVE: To evaluate high-voltage, pulse-galvanic electric stimulation as an adjunct to healing diabetic foot ulcers. DESIGN: Randomized, double-blind, placebo-controlled pilot trial. SETTING: University medical center. PATIENTS: Forty patients with diabetic foot ulcers, consecutively sampled. Twenty patients each assigned to treatment and placebo groups. Five patients (2 treated, 3 placebo) withdrew because of severe infection. INTERVENTIONS: Electric stimulation through a microcomputer every night for 8 hours. The placebo group used identical functioning units that delivered no current. Additional wound care consisted of weekly débridements, topical hydrogel, and off-loading with removable cast walkers. Patients were followed for 12 weeks or until healing, whichever occurred first. MAIN OUTCOME MEASURES: Proportion of wounds that healed during the study period. Compliance with use of device (in hr/wk), rate of wound healing, and time until healing. RESULTS: Sixty-five percent of the patients healed in the group treated with stimulation, whereas 35% healed with placebo (p = .058). After stratification by compliance, a significant difference was identified among compliant patients in the treatment group (71% healed), noncompliant patients in the treatment group (50% healed), compliant patients in the placebo group (39% healed), and noncompliant patients in the placebo group (29% healed, linear-by-linear association = 4.32, p = .038). There was no significant difference in compliance between the 2 groups. CONCLUSION: Electric simulation enhances wound healing when used in conjunction with appropriate off-loading and local wound care.

Off-loading the diabetic foot wound: a randomized clinical trial.

OBJECTIVE: To compare the effectiveness of total-contact casts (TCCs), removable cast walkers (RCWs), and half-shoes to heal neuropathic foot ulcerations in individuals with diabetes. RESEARCH DESIGN AND METHODS: In this prospective clinical trial, 63 patients with superficial noninfected, nonischemic diabetic plantar foot ulcers were randomized to one of three off-loading modalities: TCC, half-shoe, or RCW. Outcomes were assessed at wound healing or at 12 weeks, whichever came first. Primary outcome measures included proportion of complete wound healing at 12 weeks and activity (defined as steps per day). RESULTS: The proportions of healing for patients treated with TCC, RCW, and half-shoe were 89.5, 65.0, and 58.3%, respectively. A significantly higher proportion of patients were healed by 12 weeks in the TCC group when compared with the two other modalities (89.5 vs. 61.4%, P = 0.026, odds ratio 5.4, 95% CI 1.1-26.1). There was also a significant difference in survival distribution (time to healing) between patients treated with a TCC and both an RCW (P = 0.033) and half-shoe (P = 0.012). Patients were significantly less active in the TCC (600.1 +/- 320.0 daily steps) compared with the half-shoe (1,461.8 +/- 1,452.3 daily steps, P = 0.04). There was no significant difference in the average number of steps between the TCC and the RCW (767.6 +/- 563.3 daily steps, P = 0.67) or the RCW and the half-shoe (P = 0.15). CONCLUSIONS: The TCC seems to heal a higher proportion of wounds in a shorter amount of time than two other widely used off-loading modalities, the RCW and the half-shoe.

Assessing the feet of patients with diabetes.

Diabetic foot complications are common and often result in recurrent morbid events. Several studies have indicated that prevention practices are effective in preventing the development of foot ulcers and amputations. The first step in a lower-extremity ulcer prevention program is a systematic foot examination and risk stratification to select patients for more intensive prevention efforts. We provide current information on the components that should be indicated in a lower-extremity screening history and physical evaluation and a diabetic foot risk-classification scheme.

Systemic hyperbaric oxygen therapy: lower-extremity wound healing and the diabetic foot.

OBJECTIVE: To document peer-reviewed medical publications that have reported on hyperbaric oxygen (HBO) therapy as an adjunct to standard lower-extremity wound care, focusing on publications dealing with the diabetic foot. RESEARCH DESIGN AND METHODS: A review of the medical literature was conducted using MEDLINE. Research articles involving HBO treatment and the diabetic foot were critiqued to identify factors that may have been a source of bias. RESULTS: Of the published reports on human studies, seven involved diabetes-related foot pathology. Five of these studies, two of which were randomized, included a control group that did not receive HBO therapy The controlled diabetic foot studies included an average of 28 subjects in the HBO therapy group (range 10-62) and an average of 16.2 subjects in the non-HBO control group (range 5-33). Most of the published reports have several potential sources of bias, including, but not limited to, inadequate evaluation of comorbid conditions relevant to wound healing, small sample size, and poor documentation of wound size or severity. Four of the seven reports involving the diabetic foot were published by a group of researchers at the University of Milan between 1987 and 1996. CONCLUSIONS: Additional randomized placebo-controlled clinical trials in large diabetic populations would further lend credence to the presumption that HBO therapy improves clinical outcomes. Given the relatively high cost of this treatment modality, perhaps a more acute awareness of the medical literature would reduce the economic burden that HBO therapy imposes on care providers that are financially at risk.