Search Results
Recognizing the Prevalence of Changing Adult Foot Size
An Opportunity to Prevent Diabetic Foot Ulcers?
Ill-fitting shoes may precipitate up to half of all diabetes-related amputations and are often cited as a leading cause of diabetic foot ulcers (DFU), with those patients being 5 to 10 times more likely to present wearing improperly fitting shoes. Among patients with prior DFU, those who self-select their shoe wear are at a three-fold risk for reulceration at 3 years versus those patients wearing prescribed shoes. Properly designed and fitted shoes should then address much of this problem, but evidence supporting the benefit of therapeutic shoe programs is inconclusive. The current study, performed in a male veteran population, is the first such effort to examine the prevalence and extent of change in foot length affecting individuals following skeletal maturity. Nearly half of all participants in our study experienced a ≥1 shoe size change in foot length during adulthood. We suggest that these often unrecognized changes may explain the broad use of improperly sized shoe wear, and its associated sequelae such as DFU and amputation. Regular clinical assessment of shoe fit in at-risk populations is therefore also strongly recommended as part of a comprehensive amputation prevention program.
Background:
Osteomyelitis is a common complication in the diabetic foot that can conclude with amputation. The purpose of this study was to evaluate the role of diffusion-weighted magnetic resonance imaging (DWI) in the diagnosis of osteomyelitis in diabetic foot ulcer (DFU).
Methods:
Thirty patients with type 2 diabetes mellitus and a DFU were enrolled. Both DWIs and conventional MRIs were obtained. Apparent diffusion coefficient (ADC) measurements were made by transferring the images to a workstation. The measurements were made both from bone with osteomyelitis, or nearest to the injured area if osteomyelitis is not available, and from the adjacent soft tissue.
Results:
The patients comprised nine women (30%) and 21 men (70%) with a mean age of 58.7 years (range, 41–78 years). The levels of ADC were significantly low (P = .022) and the erythrocyte sedimentation rates were significantly high (P = .014) in patients with osteomyelitis (n = 9) compared with patients without osteomyelitis (n = 21). The mean ± SD bone ADC value (0.75 ± 0.16 × 10–3 mm2/sec) was significantly lower than the adjacent soft-tissue ADC value (0.90 ± 0.15 × 10–3 mm2/sec) in patients with osteomyelitis (P = .04).
Conclusions:
It is suggested that DWI contributes to conventional MRI with short imaging time and no requirement for contrast agent. Therefore, DWI may be an alternative diagnostic method for the evaluation of DFU and the detection of osteomyelitis.
Anti-inflammatory Effects of Clostridial Collagenase
Results from In Vitro and Clinical Studies
Background
Digestion of collagen with clostridial collagenase (CC) produces peptides that can induce cellular responses consistent with wound healing in vivo. However, nonhealing human wounds are typically in a state of chronic inflammation. We evaluated the effects of CC on markers of inflammation in cell culture and wound fluid from diabetic patients.
Methods
Lipopolysaccharide-induced release of tumor necrosis factor-α and interleukin-6 from interferon-γ–activated THP-1 monocytes was measured in the presence or absence of CC or CC collagen digests. In the clinical study, 17 individuals with mildly inflamed diabetic foot ulcers were randomized to receive CC ointment (CCO) or hydrogel. Weekly assessments included wound appearance and measurements. Wound exudate was collected at baseline and at 2 and 4 weeks of treatment. A multiplex assay was used to measure levels of analytes, including those associated with inflammation and with inflammation resolution.
Results
Lower levels of tumor necrosis factor-α and interleukin-6 were found in media of cells cultured with CC or CC digests of collagen type I or III than for untreated lipopolysaccharide controls (P < .05). Clinically, CCO and hydrogel resulted in improvement in wound appearance and a decrease in mean wound area. The CCO, but not the hydrogel, was found to increase the level of analytes associated with resolution of inflammation while decreasing those associated with inflammation. There was a general correlation between resolution of inflammation and healing.
Conclusions
These results support a hypothesis that debridement with CCO is associated with decreased inflammation and greater progress toward healing.
Retrospective and prospective studies have shown that elevated plantar pressure is a causative factor in the development of many plantar ulcers in diabetic patients and that ulceration is often a precursor of lower-extremity amputation. Herein, we review the evidence that relieving areas of elevated plantar pressure (off-loading) can prevent and heal plantar ulceration.
There is no consensus in the literature concerning the role of off-loading through footwear in the primary or secondary prevention of ulcers. This is likely due to the diversity of intervention and control conditions tested, the lack of information about off-loading efficacy of the footwear used, and the absence of a target pressure threshold for off-loading. Uncomplicated plantar ulcers should heal in 6 to 8 weeks with adequate off-loading. Total-contact casts and other nonremovable devices are most effective because they eliminate the problem of nonadherence to recommendations for using a removable device. Conventional or standard therapeutic footwear is not effective in ulcer healing. Recent US and European surveys show that there is a large discrepancy between guidelines and clinical practice in off-loading diabetic foot ulcers. Many clinics continue to use methods that are known to be ineffective or that have not been proved to be effective while ignoring methods that have demonstrated efficacy.
A variety of strategies are proposed to address this situation, notably the adoption and implementation of recently established international guidelines, which are evidence based and specific, by professional societies in the United States and Europe. Such an approach would improve the often poor current expectations for healing diabetic plantar ulcers. (J Am Podiatr Med Assoc 100(5): 360–368, 2010)
Background
We evaluated whether direct or indirect endovascular revascularization based on the angiosome model affects outcomes in type 2 diabetes and critical limb ischemia.
Methods
From 2010 to 2015, 603 patients with type 2 diabetes were admitted for critical limb ischemia and submitted to endovascular revascularization. Among these patients, 314 (52%) underwent direct and 123 (20%) indirect revascularization, depending on whether the flow to the artery directly feeding the site of ulceration, according to the angiosome model, was successfully acquired; 166 patients (28%) were judged unable to be revascularized. Outcomes were healing, major amputation, and mortality rates.
Results
An overall healing rate of 62.5% was observed: patients who did not receive percutaneous transluminal angioplasty presented a healing rate of 58.4% (P < .02 versus revascularized patients). A higher healing rate was observed in the direct versus the indirect group (82.4% versus 50.4%; P < .001). The major amputation rate was significantly higher in the indirect versus the direct group (9.2% versus 3.2%; P < .05). The overall mortality rate was 21.6%, and it was higher in the indirect versus the direct group (24% versus 14%; P < .05).
Conclusions
These data show that direct revascularization of arteries supplying the diabetic foot ulcer site by means of the angiosome model is associated with a higher healing rate and lower risk of amputation and death compared with the indirect procedure. These results support use of the angiosome model in type 2 diabetes with critical limb ischemia.
Background:
This randomized, prospective, multicenter, open-label study was designed to test whether a topical, electrolyzed, superoxidized solution (Microcyn Rx) is a safe and effective treatment for mildly infected diabetic foot ulcers.
Methods:
Sixty-seven patients with ulcers were randomized into three groups. Patients with wounds irrigated with Microcyn Rx alone were compared with patients treated with oral levofloxacin plus normal saline wound irrigation and with patients treated with oral levofloxacin plus Microcyn Rx wound irrigation. Patients were evaluated on day 3, at the end of treatment on day 10 (visit 3), and 14 days after completion of therapy for test of cure (visit 4).
Results:
In the intention-to-treat sample at visit 3, the clinical success rate was higher in the Microcyn Rx alone group (75.0%) than in the saline plus levofloxacin group (57.1%) or in the Microcyn Rx plus levofloxacin group (64.0%). Results at visit 4 were similar. In the clinically evaluable population, the clinical success rate at visit 3 (end of treatment) for patients treated with Microcyn Rx alone was 77.8% versus 61.1% for the levofloxacin group. The clinical success rate at visit 4 (test of cure) for patients treated with Microcyn Rx alone was 93.3% versus 56.3% for levofloxacin plus saline–treated patients. This study was not statistically powered, but the high clinical success rate (93.3%) and the P value (P = .033) suggest that the difference is meaningfully positive for Microcyn Rx–treated patients.
Conclusions:
Microcyn Rx is safe and at least as effective as oral levofloxacin for mild diabetic foot infections. (J Am Podiatr Med Assoc 101(6): 484–496, 2011)
Background:
We investigated the validity of probe-to-bone testing in the diagnosis of osteomyelitis in a selected subgroup of patients clinically suspected of having diabetic foot osteomyelitis.
Methods:
Between January 1, 2007, and December 31, 2008, inpatients and outpatients with a diabetic foot ulcer were prospectively evaluated, and those having a clinical diagnosis of foot infection and at least one of the osteomyelitis clinical suspicion criteria were consecutively included in this study.
Results:
Sixty-five patients met the inclusion criteria and were prospectively enrolled in the study. Forty-nine patients (75.4%) were hospitalized, and the remaining 16 (24.6%) were followed as outpatients. Osteomyelitis was diagnosed in 39 patients (60.0%). Probe-to-bone test results were positive in 30 patients (46.1%). The positive predictive value for the probe-to-bone test was fairly high (87%), but the negative predictive value was only 62%. The sensitivity and specificity of the test were 66% and 84%, respectively. White blood cell counts and mean C-reactive protein levels did not statistically significantly differ between groups. However, erythrocyte sedimentation rates greater than 70 mm/h reached statistical significance between groups. Wound area and depth were not found to be statistically significantly different between groups.
Conclusions:
Positive probe-to-bone test results and erythrocyte sedimentation rates greater than 70 mm/h provide some support for the diagnosis of diabetic foot osteomyelitis, but it is not strong; magnetic resonance imaging or bone biopsy will probably be required in cases of doubt. (J Am Podiatr Med Assoc 102(5): 369–373, 2012)
Background:
Although total-contact cast (TCC) systems are considered the gold standard for off-loading plantar ulcers, less than 6% of patients with diabetic foot ulcers receive them due to negative perceptions of special technique requirements and time investment in their application and removal. We compared the ease of use and casting time of four TCC systems.
Methods:
Four novice casters applied each of the four TCC systems three times using the manufacturer's written instructions for cast application and removal of each cast type. For each TCC system, casters also provided ratings of quality and effectiveness, their level of confidence in applying each system, and overall ease of use.
Results:
The time to complete the first application of each cast type was not different among TCC systems. However, by the third application, TCC-EZ had a significantly faster application time than the other three TCC systems. In addition, TCC-EZ was considered better overall in packaging and instructions, quality of cast components, and casting method than the other TCC systems. Half of the casters rated TCC-EZ and MedE-Kast as the easiest to apply after the third and final trial, and TCC-EZ and MedE-Kast were rated as being the cast chosen to use in the casters' clinical practices.
Conclusions:
One of the obstacles to use of TCC systems, despite being recognized as the gold standard of off-loading, is the perception of a prolonged learning curve on application. This study demonstrated that TCC-EZ can be applied by novice casters in less than 14 minutes after their third application experience.
Foot Complications and Mortality
Results from Translating Research Into Action for Diabetes (TRIAD)
Background: We sought to study the impact of foot complications on 10-year mortality independent of other demographic and biological risk factors in a racially and socioeconomically diverse managed-care population with access to high-quality medical care.
Methods: We studied 6,992 patients with diabetes in Translating Research Into Action for Diabetes (TRIAD), a prospective observational study of diabetes care in managed care. Foot complications were assessed using administrative claims data. The National Death Index was searched for deaths across 10 years of follow-up (2000-2009).
Results: Charcot's neuro-osteoarthropathy and diabetic foot ulcer with debridement were associated with an increased risk of mortality; however, the associations were not significant in fully adjusted models. Lower-extremity amputation (LEA) was associated with an increased risk of mortality in unadjusted (hazard ratio [HR], 3.21; 95% confidence interval [CI], 2.50–4.12) and fully adjusted (HR, 1.84; 95% CI, 1.28–2.63) models. When we examined the associations between LEA and mortality stratified by sex and race, risk was increased in men (HR, 1.96; 95% CI, 1.25–3.07), Hispanic individuals (HR, 5.17; 95% CI, 1.48–18.01), and white individuals (HR, 2.18; 95% CI, 1.37–3.47). In sensitivity analyses, minor LEA tended to increase the risk of mortality (HR, 1.48; 95% CI, 0.92–2.40), and major LEA was associated with a significantly higher risk of death at 10 years (HR, 1.89; 95% CI, 1.18–3.01).
Conclusions: In this managed-care population with access to high-quality medical care, LEA remained a robust independent predictor of mortality. The association was strongest in men and differed by race.
Topical Application of a Gentamicin-Collagen Sponge Combined with Systemic Antibiotic Therapy for the Treatment of Diabetic Foot Infections of Moderate Severity
A Randomized, Controlled, Multicenter Clinical Trial
Background:
The aim of this pilot study was to determine the safety and potential benefit of adding a topical gentamicin-collagen sponge to standard of care (systemic antibiotic therapy plus standard diabetic wound management) for treating diabetic foot infections of moderate severity.
Methods:
We randomized 56 patients with moderately infected diabetic foot ulcers in a 2:1 ratio to receive standard of care plus the gentamicin-collagen sponge (treatment group, n = 38) or standard of care only (control group, n = 18) for up to 28 days of treatment. Investigators performed clinical, microbiological, and safety assessments at regularly scheduled intervals and collected pharmacokinetic samples from patients treated with the gentamicin-collagen sponge. Test of cure was clinically assessed 14 days after all antibiotic therapy was stopped.
Results:
On treatment day 7, we noted clinical cure in no treatment patients and three control patients (P = .017). However, for evaluable patients at the test-of-cure visit, the treatment group had a significantly higher proportion of patients with clinical cure than did the control group (22 of 22 [100.0%] versus 7 of 10 [70.0%]; P =.024). Patients in the treatment group also had a higher rate of eradication of baseline pathogens at all visits (P ≤ .038) and a reduced time to pathogen eradication (P < .001). Safety data were similar for both groups.
Conclusions:
Topical application of the gentamicin-collagen sponge seems safe and may improve clinical and microbiological outcomes of diabetic foot infections of moderate severity when combined with standard of care. These pilot data suggest that a larger trial of this treatment is warranted. (J Am Podiatr Med Assoc 102(3): 223-232, 2012)
